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Feliza Mirasol is the science editor for 

On Oct. 9, 2024, Evonik announced that it has won the 2024 CPHI Excellence in Pharma Award in the “Sustainability” category for its plant-based squalene, PhytoSquene, an adjuvant that can be used for parenteral drug delivery applications. According to a company press release, the product is the first plant-based squalene on the market that complies with good manufacturing practices (GMP).

Vaccines such as the H1N1 influenza vaccine use squalene as an adjuvant. Adding it to vaccines stimulates the body’s immune response to the active ingredient. Pharmaceutical-grade squalene is currently sourced from shark liver oil, however, which runs the risk of depleting shark populations and negatively impacting marine biodiversity, Evonik stated in its press release. “In terms of quality, animal-derived squalene may be susceptible to batch-to-batch inconsistencies which can complicate regulatory processes. Some patients also cannot use animal-based products for cultural or religious reasons,” the company also stated in the release.

PhytoSquene belongs to Evonik’s Next Generation Solutions (NGS) portfolio, in which products are categorized by a distinct sustainability profile. Evonik’s Health Care business unit aims to transform more than 70% of its portfolio by revenue to NGS by 2030. This goal also includes commitments from the company’s life sciences division, Nutrition & Care, to reduce the need for animal-derived products while growing its biosolutions portfolio, according to the company.

“Sustainability drives us! This award confirms that we are pursuing the right goals: to offer our customers alternatives that enhance patient outcomes and protect our planet,” said Yann d'Hervé, head of the Health Care business line at Evonik, in the press release.

PhytoSquene is manufactured in Germany using a proprietary process. It comes from amaranth (

) oil. Amaranth is an herbaceous plant cultivated in many parts of the world, making it a renewable feedstock. The manufacturing process produces consistent quality and is compliant with 

 regulations. Evonik launched commercial-scale PhytoSquene in 2023.

In 2022, Evonik won a CPHI Pharma Award in the category “Packaging and Drug Delivery” for a polymer-based messenger RNA (mRNA) drug delivery system. The drug delivery system is also used for delivery of other nucleic acid-based therapeutics.

Evonik also announced that it is transforming its Health Care business to focus on strategic core growth areas. Under the restructuring, Evonik will evaluate strategic options, such as partnerships or divestment, to develop its keto and pharma amino acid production sites in Ham, France, and Wuming, China. The company also plans to discontinue its production of keto acids in Hanau, Germany by the end of 2025 (1).

Evonik’s Nutrition & Care, the Health Care business within the company’s life sciences division, is transforming into a system solutions provider and is growing in core areas of expertise, including complex and highly potent APIs, oral and injectable drug delivery, and precision biosolutions, such as lipids for mRNA and gene delivery, and cell culture ingredients. The company described system solutions as tailored offerings that integrate products, technologies, and services with sustainability benefits, according to an Oct. 11, 2024 company press release (1).

For the full list of the 2024 CPHI Excellence in Pharma Awards winners, read the 

1. Evonik. Evonik to Restructure Its Keto and Pharma Amino Acid Business. Press Release. Oct. 11, 2024.

Articles

Evonik won the CPHI Excellence in Pharma Award in the “Sustainability” category in recognition of its plant-based squalene, PhytoSquene, used in parenteral drug delivery applications.

Evonik Wins Award at CPHI Milan for Plant-based Parenteral Drug Delivery Adjuvant

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept. | Image Credit: © Dilok - stock.adobe.com

The California-based contract development and manufacturing organization (CDMO) SK pharmteco, which focuses on small molecules and advanced therapies, announced on Oct. 2, 2024 that it was entering into a multi-year agreement with the German biotechnology company AaviGen to be the preferred manufacturing partner for AaviGen’s lead gene therapy product, AVG-101 (1).

According to a press release from SK pharmteco, AVG-101 is intended for the treatment of heart failure; AaviGen’s business specializes in the preclinical stage, and the company is a developer of curative gene therapies for both cardiovascular and cardiopulmonary diseases (1).

"SK pharmteco stands out from the global pool of suppliers because of its extensive experience in process development and manufacturing of adeno-associated viral-based gene therapies,” Martin Busch, PhD, COO of AaviGen, said in the press release. “Additionally, their recent investments in expanding manufacturing capacity provide us with exceptional support from the earliest stages of development to the commercial phase, especially for common cardiac disorders, such as chronic heart failure."

“We are thrilled to partner with AaviGen on their innovative gene therapy for heart failure,” added Patrick Mahieux, SK pharmteco president of cell and gene, Europe. “Our deep expertise in viral vector manufacturing and our commitment to quality and efficiency make us the ideal partner to support the development and commercialization of this promising therapy. We look forward to contributing to the advancement of this groundbreaking treatment for patients in need.”

In the press release, AaviGen’s proprietary adeno-associated viral vector technology was described as being able to enable development of therapies to target, and reverse, underlying molecular causes of heart muscle dysfunction, by concentrating on areas such as cardioprotection, contractility, and energy metabolism (1).

AaviGen has been around just since 2019, while SK pharmteco is a subsidiary of SK Inc., the strategic investment company of SK Group, which the press release identified as the second-largest conglomerate in South Korea (1).

"SK pharmteco is a key partner for AaviGen as part of our strategy to develop and commercialize innovative gene therapies against diseases of the cardiovascular and cardiovascular system,” said Patrick Most, AaviGen CEO, in the press release. “The SK pharmteco team offered the trust, competence, and understanding of how a young company like AaviGen must operate in a dynamic market from the first minute of our interactions. We look forward to the collaboration with great confidence."

In late September 2024, SK pharmteco announced another partnership, that with the supply-chain service company, Cryoport (2). The two businesses will work together to provide biopharmaceutical companies with integrated logistics and manufacturing services—such as end-to-end cell and gene therapy services that include biomaterial collection, bioservices, data solutions, and shipping systems.

1. SK pharmteco. SK pharmteco and AaviGen Announce Strategic Partnership to Manufacture AaviGen’s Lead Gene Therapy Product for Heart Failure. Press Release. Oct. 2, 2024.
2. SK pharmteco. SK pharmteco and Cryoport Partner for Cell and Gene Therapy Logistics and BioServices. Press Release. Sept. 25, 2024.

SK pharmteco will be the preferred manufacturing partner for AVG-101, AaviGen’s lead gene therapy product.

AaviGen, SK pharmteco Announce Manufacturing Agreement for Heart Failure Gene Therapy

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The European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) announced that the draft joint strategy for the European Union to 2028 (EMANS 2028) is now open for public consultation. The consultation period will be open until Nov. 30, 2024.

 has been reviewed and updated as regulatory and technical situations have changed rapidly (1). New regulations (e.g., legislation to address public health emergencies and reform of the EU medicines regulations) and technical advances, such as the use of artificial intelligence (AI), have spurred the changes to the original strategy.

“Since EMANS 2025, the availability and use of AI have become more commonplace, and the network aims to harness the full potential of AI across all the EMANS focus areas. The use of digital technology and AI has the potential to transform the network’s core work of evaluating human and veterinary medicines for authorization and monitoring their safety through the EU’s pharmacovigilance system. For veterinary medicines, the network will also push ahead with its vision to implement new digital solutions in its European Veterinary Big Data strategy,” the strategy document states (1).

The strategy to 2028 will focus on creating pathways to medicines in the EU. There is also a plan to find ways to leverage data, digitalization, and AI to improve processes.Innovation and competitiveness are priorities that will be nurtured through a regulatory science and research environment, according to EMA. Strengthening the supply chain and the sustainability of the EU network are also on the agenda. Each focus area will be evaluated by EMA and HMA to assess progress and adapt approaches, if necessary.

“The six focus areas have been carefully chosen to support the network’s core work of evaluating medicines as we take strides to promote the development of medicines and ensure that they reach those who need them,” said Maria Lamas, chair of the HMA Management Group, in a press release (2).

“The overarching theme of our updated strategy to 2028 is that of change—rapid, somewhat unpredictable, but nonetheless full of promise,” said Emer Cooke, EMA executive director, in the press release (2). “It will guide the network as it seizes opportunities and meets the challenges of the near future, including preparing for and responding to public health emergencies and threats such as antimicrobial resistance. Now is the time to share your views and help shape the direction of the network for the next few years.”

Stakeholders may provide input through an online questionnaire until Nov. 30, 2024. [https://ec.europa.eu/eusurvey/runner/EMANS2028publicconsultation] The strategy will be finalized after the consultation period and be implemented through multi-annual workplans. The final strategy is expected to be adopted by March 2025.

“While EMANS 2028 cannot preempt the legislative changes or predict the future, this strategy will prepare the network for the revisions to the pharmaceutical legislation and further changes to the technological and regulatory landscape,” Cooke says in the document’s introduction.

Seizing Opportunities in a Changing Medicines Landscape, The European Medicines Agency Network Strategy 2028 (draft)

EMA. Seizing Opportunities in a Changing Medicines Landscape. Press Release. Oct. 9, 2024. 

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

EMA and HMA Publish Network Strategy for Public Consultation

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Syringe, glass vials and stethoscope on mirror surface. Color toned | Image Credit: ©New Africa - stock.adobe.com

Suitable packaging for pharmaceutical products is a must to ensure the integrity of the products is maintained, which includes making sure the product does not degrade, become contaminated, or get damaged when being transported, for example. The role packaging plays in protecting drug products is important irrespective of dosage form or administration route; however, as the drug molecules themselves become more complex, packaging has also needed to advance.

Keeping up to date with the latest regulatory and pharmacopeial guidelines and revisions is always in the best interest of a pharmaceutical company throughout all aspects of its business. In terms of pharmaceutical packaging, there are important standards and guidelines for companies to follow, not only to ensure the safety and efficacy of the medicines housed within their packaging, but also to protect and assist the patient.

“Compliance trends in the pharmaceutical packaging sector are constantly evolving but CRSF [child-resistant senior-friendly] packaging has long been a major concern,” stresses Olivier Rousseau, CEO, SGD Pharma. “In the United States, over 300 children under the age of 20 are treated in the emergency department every day, and two die as a result of unintentional poisoning (1). And in the European Union, it is the fifth leading cause of accidental death for children and adolescents. Most cases occur within the home, when children gain access to harmful substances that are improperly stored.”

While the ultimate responsibility lies with parents or carers of children to ensure medications are not erroneously consumed, pharmaceutical packaging manufacturers are also being tasked with providing packaging solutions that are child-resistant while also being as user-friendly to adults and senior citizens as possible, Rousseau explains.

“There are numerous mechanisms for child-resistant closures (CRC) on medical packaging, which are primarily categorized into re-closable (bottles) or non-re-closable (blister packs),” Rousseau continues. “In some countries, pharmaceutical and healthcare companies are required by law to produce packaging that is child-resistant, while maintaining accessibility for the consumer.”

For example, Rousseau points out the standard test procedure, published by the International Organization for Standardization, for re-closable child-resistant packaging (2). And, in Europe, he notes, several norms have been introduced that complement the ISO standard.

“Pharmaceutical companies must have certification of child resistance for the for their full solution and the time and cost related to this is significant,” Rousseau stresses. “To streamline this, drug manufacturers can partner with packaging manufacturers that can not only supply innovative, high-quality packaging, but also provide the required certification (ISO 8317:2015 in Europe and 16 

1. ChildCare Aware of America. Poisoning. 

https://www.childcareaware.org/our-issues/crisis-and-disaster-resources/poison/

Child-Resistant Packaging—Requirements and Testing Procedures for Reclosable Packages

“With highly complex biologics and other specialty drugs representing an increasing proportion of the pharmaceutical market, demand for pre-sterilized and ready-to-use (RTU) drug packaging options has increased in recent years; valued at $8.42 billion in 2022 and predicted to reach $14.23 billion by 2031 (1),” says Olivier Rousseau, CEO, SGD Pharma. “As well as this, trends such as personalized treatments in place of blockbuster drugs, increasing regulatory quality and compliance and a move towards self-medication, are changing the way that drugs are administered and therefore manufactured.”

“As the drug pipeline becomes more complex with the rise of biologics and personalized medicine, sterile drug containment and delivery systems have emerged as a great solution,” explains Robert Lindner, global product manager for Bulk and Sterile Solutions at SCHOTT Pharma. “Both prefillable polymer syringes and RTU [ready-to-use] cartridges offer the versatility to handle a wide range of drug formulations. The ability to pre-fill syringes and cartridges in a sterile environment and their compatibility with various drug formulations make them indispensable for biologics and other complex therapies and reduce the risk of contamination.”

Made from either glass or advanced polymers, prefillable syringes are a convenient option for the end user and have become a cornerstone of modern drug packaging, asserts Nina Krautwurst, global product manager for Polymer Solutions at SCHOTT Pharma. “Polymer syringes offer the advantage of being shatterproof, significantly reducing the risk of breakage during handling. This is crucial for maintaining the integrity of sensitive biologics and high-value medications. The design of these syringes has evolved to ensure they are user-friendly and safe, making them ideal for both clinical and at-home use. Their compact and robust nature facilitates easy integration into secondary packaging solutions.”

Additionally, there have been advances made in secondary packaging for prefillable syringes to ensure safe transportation and storage, specifies Krautwurst. “Modern designs focus on maintaining the syringes in optimal condition and ready for use. This includes robust and compact packaging solutions that emphasize safety and compliance,” she says. “The secondary packaging is designed to be user-friendly, facilitating easy handling and reducing the risk of contamination.”

Pharmaceutical companies are moving toward RTU components as preferred solutions to meet the needs of the market and address challenges, concurs Rousseau. “And [pharmaceutical companies] are outsourcing their packaging to trusted experts who offer sterile and RTU options, [which,] in turn, has led pharmaceutical packaging manufacturers to invest in advanced packaging facilities to meet increased demand and ensure effective and timely product delivery,” he adds.

Rousseau also points out that for primary packaging of pharmaceuticals, glass provides significant benefits, including strong chemical and mechanical performance, and sustainability. “Based on the proven success of other RTU glass primary packaging solutions, RTU molded glass vials offer a new choice to pharmaceutical industries in aseptic manufacturing and processing,” he says.

“Molded glass brings its own improved chemical durability and greater mechanical strength, combined with proved industrial platforms for RTU primary packaging as well as state-of-the-art secondary packaging systems, such as trays and nest and tubs used in fill and finish,” Rousseau continues. “Secondary packaging removes glass-to-glass contact, improving the aseptic filling lines of pharmaceutical companies and reducing the risk of failure during drug manufacturing and development. The expansion of the pre-sterilized and RTU market has triggered renewed demand for secondary packaging systems that can easily incorporate RTU offerings.”

For RTU cartridges, particularly prior to the filling stage, secondary packaging developments have focused on sterility and protection, often incorporating sterile barrier systems such as nested tubs or trays, which maintain the integrity and cleanliness of the cartridges during transport and storage, confirms Lindner. “Modern secondary packaging solutions are optimized for automation, reducing manual handling and enhancing efficiency in high-throughput production lines. This [automation] minimizes contamination risks and streamlines the transition to the filling process, reflecting the industry’s focus on maintaining sterility while improving operational efficiency,” he says.

“Patient safety is paramount to pharmaceutical packaging manufacturers,” notes Rousseau. Additionally, it is important for packaging manufacturers, such as SGD Pharma, to ensure all products not only meet all relevant regulatory guidelines to ensure safety but also that any technological advances are also considered to improve the packaging for the patient, he states.

When looking at glass vials, for example, companies can use an internal siliconization treatment that provides advanced protection for drug products that are sensitive, aggressive, and viscous, Rousseau continues. “A micro-layer of silicone is highly bonded to the internal surface of the glass vials and acts as a barrier coating to provide dual protection: preventing ion leaching from the glass into the drug product as well as blocking drug molecules from penetrating the glass primary packaging. The internal coating enhances the functional performance of the glass vial while safeguarding the integrity of the sensitive therapeutic product to ensure it is preserved when it reaches the patient,” he adds.

“Patient safety has also been supported by the development of an external treatment on the sealing surface of glass vials that protect solid oral drug products from moisture and oxygen though a hermetic seal adhesion of the foil,” Rousseau specifies. “The vials are child-resistant senior-friendly (CRSF) compatible and have tamper-evident closures, both of which help prevent accidental ingestion.”

“Advances in drug packaging have played a crucial role in improving patient safety through several key innovations,” states Krautwurst. “Prefillable polymer syringes have significantly contributed to patient safety by offering features designed to reduce medication errors and improve the administration process. These syringes often come with tamper-evident closures, ensuring that the medication has not been compromised before use.”

Dosing errors are prevented through clear, easy-to-read labeling on the polymer syringes, which provides accurate information about the medication housed within, points out Krautwurst. “The design of these syringes allows for precise dosing, which is particularly important for administering potent biologics, ensuring that patients receive the correct amount of medication,” she says. “Additionally, using advanced polymer materials reduces the risk of contamination and particle generation, enhancing the overall safety profile of the drug.”

Another advancement in packaging, driven by the trend to large-volume subcutaneous injections, is that of specialized containers. These larger cartridges and prefilled syringes “have been developed to handle higher volumes of medication higher volumes of medication while maintaining drug stability and ensure patient comfort during administration,” remarks Lindner.

“Packaging often integrates with wearable devices, autoinjectors, or infusion pumps, enabling patients to self-administer larger doses safely and conveniently outside clinical settings,” adds Lindner. “This reduces the need for frequent hospital visits and allows for more consistent treatment adherence. Innovations in packaging have prioritized sterility and ease of use, essential for patient safety. Sterile packaging minimizes the risk of infection, while user-friendly designs help ensure patients can administer their medications correctly and comfortably. These advancements reflect a strong focus on improving patient outcomes and supporting the unique demands of complex therapies.”

Furthermore, leveraging innovative technologies to make packaging more interactive has the potential to improve overall health outcomes for patients, asserts Lindner. “These innovations can be incorporated into RTU containers’ packaging to give patients instant access to dosing instructions, reminders, and other critical information via their smartphones,” he says. “This enhanced connectivity fosters greater patient engagement and compliance, which is essential for effectively managing chronic conditions.”

While patient safety is obviously critical, other factors that can help make a product appealing to the patient must also not be overlooked. “During recent years, the demand for sustainability has accelerated throughout the packaging industry and has had a particular influence on the pharmaceutical industry,” notes Rousseau. “Consumers are now more environmentally conscious than ever before, and sustainability has become a key factor in their decision-making. In a recent survey (2), FEVE [The European Container Glass Federation] revealed that three out of four European consumers find that purchasing sustainable products makes a difference for our environment.”

Rousseau highlights that “glass is already a highly sustainable packaging material and is [now] 70% less energy intensive than 50 years ago (3). However, in response to growing consumer demand,” he continues, “the glass packaging industry is striving to improve this further, investing around €600 million [US$670 million] each year on updates to manufacturing facilities and steps in the supply chain to improve energy efficiency.”

“Sustainability has become a driving force in the evolution of drug packaging,” confirms Krautwurst. For syringes, polymer materials provide a lightweight option that require less energy to produce and transport than other materials, which can result in a lower carbon footprint, she remarks. Further, high durability of polymer syringes can lead to fewer breakages and hence less waste during handling and transportation, Krautwurst states.

“Drug packaging has also become more sustainable through efforts to reduce its ecological impact, such as using steam-sterilized RTU cartridges. Steam sterilization, which operates with ultrapure water and heat, requires lower energy levels for the same or better microbial kill rates than chemical or radiation-based sterilization techniques, reducing the overall carbon footprint,” says Lindner. “Additionally, steam sterilization does not produce harmful residues or by-products. Further innovations include using eco-friendly materials and designs that minimize waste and energy consumption.”

Along with an increased demand for greener practices from consumers, regulatory pressures and overall industry goals to lower carbon footprints are driving the shift towards sustainability, adds Lindner. “These advancements aim to balance effective sterilization with environmental responsibility, reflecting a broader commitment to sustainability in the pharmaceutical industry,” he concludes.

Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market Size, Share and Trends Analysis Report by Type of Container (Sterile Cartridges, Sterile Syringes, and Sterile Vials), by Type of Closure (Caps, Plungers, Seals, Stoppers, Tip Caps/Needle Shields), by Material of Fabrication, Region, and Segment Forecasts, 2023-2031

FEVE. Sustainability and Climate-Neutral Production. 

feve.org/glass-industry-positions/sustainability-climate-neutral/

Glass Hallmark. Why Glass is Best for Pharmaceutical Packaging. 

Felicity Thomas is associate editorial director for 

®
Vol. 48, No. 10
October 2024
Pages: 10–14

When referring to this article, please cite it as Thomas, F. Out-of-the-Box Packaging Advancements. 

Pharmaceutical packaging must advance to adapt to new, complex modalities.

Out-of-the-Box Packaging Advancements

CPHI Milan 2024: Pharma Industry Growth and Investment

spoke with John McQuaid, president and managing director at Almac Pharma Services, at CPHI Milan 2024, held October 8–10, in Milan, Italy, about how the pharmaceutical industry is growing and what might drive investment in the future. McQuaid also discusses the demand for analytical services and the challenges to provide those services that contract development and manufacturing organizations (CDMOs) face.

“There's quite a diverse range of drivers at the moment, anything from the BIOSECURE Act in the [United States], geopolitical factors such as that, right through to technology needs for emerging modalities,” McQuaid said. “If I speak about pharmaceutical development, first, there's never been a larger number of molecules in clinical development, and we're certainly seeing that increasing demand. We've got demand in areas such as [highly] potent [APIs], [and] age-appropriate formulations, such as pediatrics. We've got poorly soluble compounds, and the need for technologies to address that. And then we've got personalized medicines, such as, … cell and gene therapies, which drive particular needs in areas such as fill/finish and cold chain requirements.”

Commercially, McQuaid sees the rise of glucagon-like peptide-1 (GLP-1) drugs as driving demand and supply chain concerns. Auto injectors are also in demand as device combinations are common, and therefore, a growing area of the market. “And then the feedback we're also getting from many of our clients is that small molecules and small-molecule pipelines are particularly strong and healthy at the moment, and that's driving demand as well.”

Almac is addressing some of these areas by investing in technologies such as mini tablets for pediatrics and spray drying for poorly soluble compounds. “We're investing in cold chain capabilities, both for the clinical phases and the commercial phases, and then we have peptide synthesis coming online early next year at our API plant in Craigavon, with small molecule expansion kicking in later next year, and then further program for larger-scale API manufacturing.”

Videos

Pharmaceutical Technology Europe spoke with John McQuaid, president and managing director at Almac Pharma Services, at CPHI Milan 2024, held October 8–10, in Milan, Italy, about how the pharmaceutical industry is growing and what might drive investment in the future.

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Experts in cell and gene therapy weigh in on hot topics in a quick-hitting buy, sell, hold format before expanding their thoughts on complex questions. 

Buy, Sell, Hold: Cell and Gene Therapy

 is a rapid-fire expert panel covering a single topic, such as lipid nanoparticle delivery, supply chain resilience, 

 (CGT), or aseptic filling. Panelists first respond to quick-hit questions with a buy, sell, hold format before being allotted more time to share more considerate responses to complex topics.

While finance and investment perspectives flavor the discussion, science and pragmatism are the main ingredients driving these dynamic panel discussions.

“Episode 1: Cell and Gene Therapy” features the expertise of Dr. Fabian Gerlinghaus, co-founder and chief executive officer of Cellares; Dr. Claudia Zylberberg, board chair and co-founder of Arscience Biotherapeutics, and board chair and co-founder of Akron Biosciences; and Benjamin McLeod, director, Cell & Gene Therapy Segment, at NanoMosaic.

In the first 2 segments, the panelists share quick thoughts on CGT topics, including: The merits of focusing on orphan diseases; training new staff versus re-training existing staff; machine learning, artificial intelligence, and quantum computing; existing supply chain functioning; government investment into CGT; using traditional CDMOs for CGT production; facility retrofits for CGT; and CGTs as first-line treatment.

In the final segment, panelists had up to two minutes each to weigh the advantages and disadvantages of gene editing (CRISPR), gene augmentation, and gene-silencing approaches. Panelists also discussed their technology or engineering wish lists, as well as how to best to sync up regulations to current technology progress. Lastly, they exchanged ideas about the key missing piece(s) to lowering cost and improving accessibility.

Click here for more episodes of Buy, Sell, Hold

Dr. Fabian Gerlinghaus, Co-Founder and CEO, Cellares

Fabian Gerlinghaus is Co-Founder and Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about building the future of cell therapy manufacturing. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honors degree in technology management from the Center for Digital Technology and Management, Munich

Dr. Claudia Zylberberg, Board Chair and Co-Founder Arscience Biotherapeutics, Board Chair and Co-Founder Akron Biosciences

With over 30 years of experience in the regenerative medicine industry, Dr. Zylberberg has established herself as a leader in her field. For nearly 15 years, she led Akron Bio as its founder and CEO with leadership, foresight, and expertise in advanced therapies manufacturing. Her passion for pushing the industry forward in the development and commercialization of safe novel therapies also led her to co-found the Standards Coordinating Body and serve as an active member of numerous industry boards and advisory committees. Claudia co-founded AssureImmune, an adult stem cell bank, and worked with Nabi Pharmaceuticals, specializing in human plasma-derived products. Her experience in product development and protein manufacturing was instrumental in the development of key materials to accelerate the regenerative medicine industry. She holds numerous patents and developed several patent-pending platform technologies in cryopreservation, novel formulations, and others. Claudia received her PhD from the University of Buenos Aires, where she studied Immunology, and conducted her doctoral research at the University of British Columbia. She also authored a children’s book called You’re Full of Genes to introduce the younger generation to genetics. Claudia is a member of the Forum on Regenerative Medicine at the National Academies of Sciences, Engineering, and Medicine.

Benjamin McLeod, Director, Cell & Gene Therapy Segment, NanoMosaic

Currently Benjamin helps many related researchers become more familiar with CGT concepts by translating complex processes into digestible bites on social media platforms such as LinkedIn and X. At OmniaBio he was product manager, collaborating with technical stakeholders to develop clear and actionable messaging around OmniaBio’s manufacturing services. At Virica Biotech he was Technical Lead, for a company whose viral sensitizer technology, increased viral yield in manufacturing, and potency in viral therapeutic products.

In episode 1, cell and gene therapy experts Dr. Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT. 

On the final day of CPHI Milan 2024, Oct. 10, 2024, a panel brought together by Fujifilm Diosynth Biotechnologies debated the numerous paths to “Building the Future Pharma Workforce” (1,2). Moderated by Pushpa Vijayaraghavan, healthcare practice lead at Sathguru Management Consultants, the other contributing panelists were Nagarjun Chakilam, director of Maithri Drugs; Jakub Knurek, business development specialist at Mabion; Morgan Rex, senior quality engineer at ApiJect; and Megan Smyth, senior team leader at Almac Group.

“There's two significant changes that I've really seen in my nine years of being in the industry so far,” Rex said. “The first is that there's a general trend, and this is really relevant in the United States, to bring healthcare out of the hospital in[to] the clinic and bring it directly to the patient as much as possible. And that trend is being driven by this desire to decrease the cost of healthcare while also increasing the access to healthcare, which will increase the adherence of patients to their medicine, which will improve vaccine accessibility—and so that's what we're seeing in the developed world, and … we're creating different formats for drug delivery and injections.”

Accelerating these changes in the industry have been some necessary adjustments in workflow and, in tandem, newly forged technologies resulting from the COVID-19 pandemic.

“So, the way it impacted us is, you know, [to] think about digitizing all the quality processes,” Chakilam said. In the past, quality processes were manual and siloed, according to Chakilam. “But now for us to embrace these new technologies, what we thought was it is more crucial and more important to digitize them first, and not just digitization like transforming from paper to screen or just doing something on the computer, but we want to have all those systems integrated in the back end as well.” Chakilam suggested technology trends be embraced and for the industry to move to implement flow chemistry once digitalization is completed. “Maybe at that point it will be a little bit more easier and more effective.”

“We're really excited about how we can unleash the power of AI [artificial intelligence] in our roles, in our organizations and our industry,” moderator Vijayaraghavan added. “How do we get our human capital, the security that there is still a people-driven future here? And how should people think of staying ahead of this curve and not feeling threatened by it, but, you know, being part of [the] revolution?”

Discussing the rise of women in leadership positions in the pharmaceutical industry, Vijayaraghavan made light of the expert panel consisting of more women than men, a point that was then elaborated on by Knurek.

“In every gender, [to] have that passion for biotech, for improvement that's really challengeable for all companies, how we can search, I think, more about headhunting, talent acquisition from that perspective?” he said.

In any case, Smyth said, the industry is expanding, and job recruitment is hearty. “There's just so many opportunities to be able to do so much in this industry. And you know, we've been building our capabilities towards manufacturing, and yeah, I think I'm really excited,” she said. “It's not going to be without its challenges, because we're doing a lot of these things for the first time, and it's exciting to be an innovator, but it's also going to have the challenges that need to be problem solved. And I think ultimately that's why most of us are in this industry, to be able to improve it and make it better.”

1. Vijayaraghavan, P.; Smyth, M.; Chakilam, N.; Rex, M.; and Knurek, J. Building the Future Pharma Workforce. Presentation at CPHI Milan 2024, Milan, Italy, Oct. 10, 2024.
2. CPHI Milan, Conference Agenda. cphi.com/europe/en/whats-on/agenda (accessed Oct. 10, 2024).

Five speakers discussed the impact of the COVID-19 pandemic, the rise of artificial intelligence, more women in leadership tracks in the industry, and various emerging technologies.

CPHI Milan 2024: What Does the Future Pharma Workforce Look Like?

The microbiologist is testing the microbial contamination in the sample under vertical laminar air flow cabinet, concept of microbial laboratory in pharmaceutical industry, selective focus photograph. | Image Credit: ©Sukjai Photo - stock.adobe.com

Submitted: April 14, 2024
Accepted: July 9, 2024

Previously, a silver-based disinfectant composed of a low concentration (approximately 0.015% by weight) of a suspension of silver was sporicidal with a one-minute wet-contact time. The proprietary technology, licensed by the Environmental Protection Agency, for producing the silver particles has been enhanced to produce more consistent numbers and sizes of silver particles in the active raw material. Confirmatory testing has been performed on three manufactured lots to verify the consistency of disinfectant efficacy in accordance with 

United States Pharmacopoeia (USP) 37–National Formulary

 32. Various microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times. These evaluations were designed to demonstrate that the enhanced disinfectant had a similar disinfectant efficacy as the previously tested product. Sterility testing suitability on the disinfectant was demonstrated according to the 

. Sterility testing on all three lots of disinfectant was satisfactory.

It was previously reported that a silver-based disinfectant composed of a low concentration (approximately 0.015% by weight) of a suspension of silver was sporicidal with a one-minute wet-contact time (1). The proprietary technology for producing the silver particles has been enhanced to produce more consistent numbers and sizes of silver particles in the active raw material. The new product is licensed by the Environmental Protection Agency (EPA) (EPA Registration Number 96194-1, 10 March 2021). Confirmatory testing has been performed on three recently manufactured lots to verify the consistency of disinfectant efficacy in accordance with the 

 32 (2). Various microorganisms including molds and bacterial spores were tested on stainless-steel coupons and demonstrated 2-6 log reductions with one-minute wet-contact times. These evaluations were designed to demonstrate that the enhanced disinfectant had a similar disinfectant efficacy as the previously tested product. Sterility testing suitability on the disinfectant was demonstrated according to the 

 (3). Sterility testing on all three lots of disinfectant was satisfactory.

The antimicrobial effects of silver (Ag) have been recognized for thousands of years. In ancient times, it was used in water containers (4) and to prevent putrefaction of liquids and foods. In 1884, silver nitrate drops were introduced as a prophylactic treatment for the eyes of newborns, to prevent infections caused by 

 transmitted from infected mothers during childbirth (5). In 1928, the “Katadyn Process” for water purification, based on the use of silver in water at low concentrations, was introduced (6).

The bactericidal efficacy of silver and its associated ions is through the strong binding with disulfide (S—S) and sulfhydryl (—SH) groups found in the proteins of microbial cell walls. Through that binding event, normal metabolic processes 

of the cell are disrupted, leading to cell death (7). There is also evidence that after entering a cell the silver ions displace the hydrogen bonds between adjacent nitrogen molecules of purine and pyrimidine bases which may stabilize the DNA helix and prevent replication of the DNA and, subsequently, division of the cell (8).

John M. Lindsay (SM) ACM, is president, Aseptic Solutions, Inc.

®
Vol. 48, No. 10
October 2024
Pages: 27–33

When referring to this article, please cite it as Lindsay, J. M. A Silver-Based Disinfectant—Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations. 

Various microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times.

A Silver-Based Disinfectant—Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations

AAPS PharmSci 360 2024: Predictive Models for Poorly Soluble Drugs

As a preview of what’s to come at this year’s AAPS PharmSci 360, being held Oct. 20–23, 2024 in Salt Lake City, Utah, 

® sat down with Niloufar Salehi, advisor at Eli Lilly & Company, to discuss the problems associated with the formulation of poorly soluble drugs. Salehi also provided a look at how predictive models and other tools can be used to predict and improve solubility in both small-molecule and biologic drugs.

“There are several predictive tools that are used in order to determine poor solubility at [the] early stage of development,” says Salehi in the interview. “One of those is, for example, in silicon modeling that involves using computer simulations to provide insight on how [a] drug will behave in different media, and that can help scientists to identify the potential solubility issues before going any further. Also, another approach is high-throughput screening, which allows [a] researcher to quickly test the solubility of a large number of compounds, and that's enabled the scientists to identify whether there is any modification required for the further development.”

Click the above video to watch the full interview.

Salehi will be moderating the Symposium: Accelerated Development of Poorly Soluble Drugs Using Predictive Tool at AAPS PharmSci 360 on Tuesday, Oct. 22, 2024. Presentations include the following:

Biorelevant Media and Relevance in Current Time
Speaker: Sandra Klein, University of Greifswald

 Predictive Tools in Early Drug Product Development
Speaker: Fady Ibrahim, Sanofi

Role of Multi-Compartment Systems for Low-Solubility Weak Base Drug
Speaker: Yasuhiro Tsume, University of Michigan

 Predictive Dissolution Data with Pre-Clinical and Clinical Studies
Speaker: Stephen D. Stamatis, Eli Lilly & Company.

Pharmaceutical Technology sat down with Niloufar Salehi, advisor at Eli Lilly & Company, to talk about the session she is moderating at AAPS PharmSci 360 2024, Symposium: An Accelerated Development of Poorly Soluble Drugs Using Predictive Tool.

CPHI Milan 2024: Pharma Developments in Emerging Markets

 sat down with Rafael Ferrer, interim chief business officer at Acino, to talk about expansion into emerging markets, such as Latin America. Acino has been concentrating recent efforts there, in Africa, and in the Middle East, and Ferrer says the new drug pipeline often doesn’t extend to these areas.

“A large part of what we're trying to do is really be able to bring access to innovative drugs to patients in these geographies today,” Ferrer says. “If you look at the data, more or less, of 100 or so products that have been launched in the last 10 years, let's say novel molecular entities, be it new chemical entities or new biologic entities, only about 10% to about 30% of those ever make their way to emerging markets. So, there's a significant gap in terms of access to novel therapeutic modalities and novel medicines across our geographies. And for us, we see it as a mission to be able to improve access to novel medicines, while at the same time, of course, continuing to provide, you know, high-quality, well-known, well-proven brands, which are a large part of our portfolio.”

Ferrer also talked about the pitfalls of the regulatory landscape when it comes to these markets.

“The regulatory complexities and realities of Brazil are not the same as those of South Africa or the ones in Kuwait or the UAE, right?” he says. “So, we have to take that into consideration. I think [we] at Acino are very well positioned in the sense that not only do we have in-market teams that truly understand the local regulations and are able to work with regulators, with the regulatory bodies, to understand what are the pathways of getting new drugs, new medicines, to market across those markets, but also are really uniquely positioned to be able to execute on that, with the overall support that we have behind the corporation that we built.”

 is being held from Oct. 8–10, 2024 in Milan, Italy.

Rafael Ferrer, interim chief business officer at Acino, talked about his company's recent efforts to reach customers in Africa, the Middle East, and most recently, Latin America.

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