Aligning mRNA Progress with Regulatory Streamlining

BioPharm Peer Exchange

Drug Solutions Podcast: 

Employing novel technologies and more patient-centric approaches

Integrating Strategies for Formulation Success

Delving into Biopharmaceutical Development and Manufacturing

Drug Digest: 

 Quality Considerations in Changing Excipient Providers

Ask the Expert

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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Piramal Pharma Solutions, a division of Mumbai-based Piramal Pharma Limited, announced on Sept. 30, 2024 that it is planning to invest $80 million into an expansion of its site in Lexington, Ky., that specializes in sterile compounding, liquid filling, and lyophilization for sterile injectable drug products (1).

A previous, $25 million expansion of this facility was announced in 2016 (2). At that time, a high-speed vial filling machine, an isolator-based vial filler, two lyophilizers, and automated vial washing and sterilization mechanisms were installed. In the September 2024 phase of expansion, 24,000 square feet of manufacturing space, a new laboratory, and state-of-the-art equipment—a new filling line, two commercial-sized lyophilizers, a capping machine, and an external vial washer—are being added, according to Piramal (1).

“This expansion represents a strategic investment in the future of Piramal Pharma,” Nandini Piramal, Piramal Pharma chairperson, said in a press release (1). “Filling the commercial manufacturing gap enables the Lexington site to access the rapidly expanding injectables market and establish itself as a key player in the segment.”

When completed, which Piramal said will be by the first quarter of 2027, the expansion made possible by this investment will increase the Lexington site’s manufacturing capacity from its current peak level of 104 product batches per year, to more than 240.

“The injectables market has steadily increased in recent years and there is currently insufficient supply,” said Peter DeYoung, CEO of Piramal Global Pharma, in the press release. “We are committed to adapting to meet this rising demand. This expansion will significantly enhance the capacity and capabilities of our Lexington facility, positioning Piramal Pharma as a comprehensive partner across the entire product lifecycle and enabling us to provide treatment solutions to more patients.”

News of the expansion investment caught the attention of Kentucky politicians and other officials.

“Kentucky’s business-friendly climate, prime location and access to resources make it an ideal destination for companies to locate, expand, and thrive,” said Kentucky Governor Andy Beshear in the press release. “The decision by Piramal Pharma Solutions’ leadership to expand and reinvest here is a testament to their trust and belief in what this great state has to offer.”

“Piramal Pharma Solutions’ decision to expand its Lexington operations is a significant step forward for our region’s economic growth,” said Bob Quick, president and CEO of Commerce Lexington. “This investment not only demonstrates Piramal Pharma’s confidence in our community and workforce but also underscores Lexington’s position as a prime location for innovative companies to grow and thrive.”

In March 2024 at the Drug, Chemical & Associated Technologies (DCAT) conference, 

 spoke with DeYoung about the company’s offerings (3). You can view that interview 

1. Piramal Pharma Solutions. Piramal Pharma Solutions Announces $80M Expansion Plan for Sterile Injectables Facility in Lexington, Kentucky. Press Release. Sept. 30, 2024.
2. Pharmaceutical Technology Editors. 

Piramal to Expand Sterile Manufacturing in Kentucky.

, Aug. 3, 2016.
3. Piramal Pharma Solutions. 

Articles

When the expansion is completed, Piramal expects manufacturing capacity to be increased by the first quarter of 2027 from 104 product batches per year to more than 240.

Piramal to Invest $80 Million in Sterile Injectables Facility Expansion in Kentucky

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

Aaron Cowley, PhD, chief technical officer and co-founder, Captozyme, discussed the advancement in development of microbiome-derived therapeutics at BIO 20204. 

Advancing Development and Manufacturing of Microbiome-Derived Therapeutics (BIO 2024)

At BIO 2024 in San Diego, Calif., which was held on June 3–6, 

® Group’s Chris Spivey spoke with Aaron Cowley, PhD, chief technical officer and co-founder, Captozyme, and chief scientific officer, ReciBioPharm, the biologics unit of Recipharm following a spate of acquisitions (1–3). 

Aaron Cowley, PhD, Chief Technical Officer and Co-founder, Captozyme, and Chief Scientific Officer, ReciBioPharm. Image courtesy of ReciBioPharm.

The age of the microbiome, according to urban legend, was ushered into existence when Francis Collins, head of National Institutes of Health (NIH) (on a “nano-sabbatical” to the Broad institute), was discussing with Eric Lander the probable slowdown in funding the sequencing of “simply more organisms” for the sake of keeping infrastructure and technology refinements going. In that discussion, Collins suggested that the hitherto unheralded organism surrounding and living within the already sequenced organisms should provide significantly valuable biological data about both the disease states, as well as the underpinnings of good health, within said organisms.

Fast forward to today, and the field of microbiome research has dramatically matured, alongside the processes, analytical development, and manufacturing of living biological products (LBPs) that have, in many ways, become an end result of this line of inquiry. The potential of this therapeutic class concomitantly gives rise to the need for specialized support to develop and manufacture microbiome-derived therapeutics and has led to a rise in companies providing LBP-related solutions. As stability of product and reproducibility of manufacturing processes have become more standardized, the regulatory support environment and guidance has, of necessity, been playing catchup. This is in large part due to LBPs’ unique mechanisms of action and the absence of well-established precedents—and, also, a deeper understanding of the interaction between well-characterized administered microbial strains and host microbiome.

As a chemist by training Aaron Cowley, PhD, chief scientific officer, ReciBioPharm, became interested in the relationship between enzymes and microbes and the products of those interactions. In the interview, Cowley stated that “As a bio-factory the redox potentiometry of microbes is an important element to microbes andtheir function”. He continues to explain how gut microbes “regulate your body”.

“The microbiome keeps you in homeostasis. If you have too much extra sugar, the microbiome will shift upwards to be able to degrade that sugar. And if you have too much of other food types, it will shift downwards. Most CDMOs [contract manufacturing and development organizations] work with 

] and yeast that love air and need oxygen. There [are] very few [microbe species] [for whom] oxygen is actually a four letter word. So, being able to do tech transfer and train people has blossomed into its own field. There are a few hundred microbiome companies now, and it’s a challenging field because there are trillions of organisms in the gut, and their functions all vary. So, being able to pull out a few organisms to show cause-and-effect in disease is like trying to find life in the universe. It’s quite daunting,” Cowley explained.

Despite this, and while automating and optimizing manufacturing remains a priority, Cowley is enthusiastic about the rapid evolution of advanced therapy medicinal products in general and how, in some ways, the combined and overlapping lessons are helping provide new and more powerful insights. These individual-patient-by-individual-patient data streams, when seen from a pattern-recognition prism, can be combined to reflect back on or give the ability to both understand and deliver a more personalized approach to medicine.

1. Arranta Bio. Arranta Bio Announces the Acquisition of Captozyme, Creating a Center of Excellence for Microbiome Development and Clinical Supply. Press Release. Nov. 13, 2019.
2. Recipharm. Recipharm Acquires Arranta Bio, a CDMO Leader in Advanced Therapy Medicinal Products (ATMPs), to Expand Its Biologics Offering in the US. Press Release. Feb. 18, 2022.
3. Recipharm. ReciBioPharm: Biologics. 

Videos

Aaron Cowley, PhD, chief technical officer and co-founder, Captozyme, discussed the advancement in development of microbiome-derived therapeutics at BIO 20204.

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

Securing the Supply Chain for Small-Molecule APIs and Excipients

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, 

Group, interviews experts about small-molecule APIs and excipients. During the first segment of the interview, Kevin Webb, Chief Operating Officer of the API Innovation Center delves into the trends driving change in the small-molecule API space, the importance of supply chain resilience and approaches being used to secure small-molecule API supply chains, the benefits of advanced manufacturing approaches in reshoring, the hurdles facing reshoring efforts, and potential future trends that may impact the small-molecule API space. Next up, Nigel Langley, Global Technical Director, Life Sciences, Gaylord Chemical Company, goes into detail about supply chain security for excipients, the potential impact of using non-compendial materials in a formulation, and some best practices that should be employed to ensure that no adulterated and non-compendial materials enter drug development processes. Additionally, he provides a teaser as to what viewers can look forward to at an upcoming panel discussion, taking place at CPHI in Milan.

Kevin Webb is the Chief Operating Officer of the API Innovation Center where he has direct responsibility for business operations, programs, strategy and external engagement. He leads the API Innovation Center’s efforts at a national and regional level to strengthen domestic pharmaceutical manufacturing in the U.S. and is a subject matter expert and featured speaker on the importance of securing our national health security.

Kevin brings 30 years of experience in the healthcare industry with broad, cross-functional technical expertise in government affairs, communications, manufacturing, operations, sales and brand management. He is a highly respected and trusted representative of the pharmaceutical industry.

Prior to the API Innovation Center, Kevin held leadership roles at Mallinckrodt Pharmaceuticals, Sanofi Pasteur Vaccines and Memorial Medical Center, a tertiary health center in Central Illinois. He holds an MBA from the University of Illinois and a Bachelor of Science from St. Louis University.

Nigel Langley, Global Technical Director, Life Sciences, Gaylord Chemical Company LLC, provides technical support to the pharmaceutical industry and helps solve drug formulation challenges. Prior to joining Gaylord Chemical Nigel has held various senior technical and marketing positions with BASF and Croda International PLC. Nigel has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (liquid crystals) from the University of Hull (UK) and an MBA from Leeds University (UK). He also took a 2- year Postdoctoral research position at Leeds University (UK) in natural product synthesis. He has over 100 scientific publications and has co- edited 3 books. Nigel is an adjunct professor at the University of Mississippi and a Fellow of the Royal Society of Chemistry (UK). In 2018 he was awarded the Industry Research Achievement Award in Excipient Technology by the IPEC Foundation. He has been a member of the Executive Committee at IPEC- Americas since 2010 and is currently Chair.

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

 Solid Dosage Development and Manufacturing

 Emerging Therapies and Targeted Delivery

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, Pharmaceutical Technology Group, interviews experts about key trends impacting small-molecule APIs and excipients, the importance of supply chain resilience, ways in which advanced manufacturing approaches can prove beneficial, and potential hurdles facing companies seeking to secure their small-molecule API and excipient supply chains.

Drug Digest: Securing the Supply Chain for Small-Molecule APIs and Excipients

Behind the Headlines: Sickle Cell Therapies; Mpox Vaccines; and ARCH Ventures’ Biotech Fund

This Behind the Headlines news roundup panel discussion on recent news items includes updates regarding sickle cell therapies (e.g,, Pfizer’s withdrawal of Oxbryta and Vertex’s choosing of Lonza as the commercial manufacturer of Casgevy); Emergent BioSolutions $400 million BARDA contract for an mpox vaccine; and the first in a generation novel schizophrenia drug, Cobenfy (xanomeline and trospium chloride). The panel also examines investment revival with ARCH Ventures $3 billion biotech fund raise and the $3.6 billion for Flagship Pioneering. Rounding things out is a discussion on COVID-19-associated childhood myopia and patent thickets artificially keep the price of drugs high.

Pfizer’s withdrawal of Oxbryta, one of a limited number of treatments that won accelerated FDA approval in 2019, surprised doctors, patients, investors, and analysts. CNBC News stated, “Oxbryta was one of the centerpieces of Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics in 2022” (1). Vertex’s gene therapy, Casgevy (exagamglogene autotemcel), was given commercial-scale manufacturing capabilities when Vertex chose Lonza as its contract manufacturing and development organization for global release. This marks a major milestone in gene editing’s future deployment, and much will be learned about what is feasible, and what requires a re-think. Interestingly, Casgevy does not address the root cause of sickle cell but instead suppresses the suppressor of infant hemoglobin production, hence essentially diluting the problems of limited healthy hemoglobin by creating an alternate supply naturally only available to infants (2).

Emergent BioSolutions contract with the Biomedical Advanced Research and Development Authority (BARDA), worth $400 million, for mpox vaccine production comes at a time when we must ask ourselves, was this new strain outbreak controllable had the US government not destroyed its aging stockpiles of the older traditional? In an example of vaccine nationalism, “While waiting on a freeze-dried long shelf-life vaccine to be developed, the United States let its stockpile of liquid monkeypox vaccine languish and expire. By 2017, all 27,993,370 doses in the national Jynneos stockpile had expired, although the US still had a huge stockpile of its other smallpox vaccines. While waste per se is shameful, it’s akin to Greek tragedy when the rise in monkeypox cases internationally is associated with lost opportunities to improve millions of people’s lives in sub-Saharan Africa, where smallpox was eradicated in 1980, and vaccinations halted” (3).

After a generation of few new treatments for schizophrenia, Bristol Myers Squibb’s $14 billion deal for Karuna Therapeutics has borne fruit with the approval of a highly promising new drug with a novel mechanism of action (4).

Constantino, A. and Capoot, A. Healthy Returns: Pfizer Pulls Sickle Cell Disease Drug from Markets–Here’s Why it Matters. 

Spivey, C. New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia. PharmTech.com. Nov. 30, 2023.

BMS. US Food and Drug Administration Approves Bristol Myers Squibb’s COBENFY (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults. Press Release. Sept. 26, 2024.

Benjamin McCloud is co-founder of Stealth Co.

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

This Behind the Headlines news roundup panel discussion on recent news items includes updates regarding sickle cell therapies (e.g,, Pfizer’s withdrawal of Oxbryta and Vertex’s choosing of Lonza as the commercial manufacturer of Casgevy); Emergent BioSolutions $400 million BARDA contract for an mpox vaccine; and the first in a generation novel schizophrenia drug, Cobenfy (xanomeline and trospium chloride). The panel also examines investment revival with ARCH Ventures $3 billion biotech fund raise and the $3.6 billion for Flagship Pioneering. Rounding things out is a discussion on COVID-19-associated childhood myopia and patent thickets artificially keep the price of drugs high.


To emphasize its four core principles that revolve around the concept of sustainability, the Italy-based contract development and manufacturing organization (CDMO) ICE Pharma will have a 100% recyclable booth constructed at its designated exhibition location at CPHI Milan from Oct. 8–10, 2024, the company said in a press release on Sept. 25, 2024 (1).

spoke with ICE Pharma marketing and communications manager Concetto Andrea Rizza

 about sustainability and the company’s green strategy, and at that time, it was mentioned that the 2023 booth would be “stored and re-deployed at future conferences,” saving these materials from the typical landfill fate” (2).

Accordingly, the stand embraces the principles of “reduce, reuse, recycle,” ICE Pharma said in its press release, by using eco-sustainable materials, namely white honeycomb cardboard and linoleum (1). The lifecycle of the setup of the stand was also designed to be fully environmentally sustainable, beginning with the design and production stages and moving onto its use and either disposal or reuse.

Material waste generated during production has been repurposed into functional furniture for the booth, such as seats and tables, according to ICE Pharma (1). Recovered material was integrated into new components to save it from being otherwise discarded; this includes optimizing the design of the cuts of the cardboard panels.

Sustainability is not the characteristic for which ICE Pharma is chiefly known, however. The company’s specialty in developing drug treatments derived from bile acids and its capabilities in providing products and services for the pharmaceutical and healthcare industries are well known.

"We offer a distinctive portfolio of bile acid products,” said Roger Viney, PhD, ICE Pharma chief commercial officer, in the press release. The company is also a major producer of ursodeoxycholic acid (UDCA). “Additionally, our CDMO services include contract manufacturing for both solid- and liquid-finished dosage forms of UDCA and other difficult-to-formulate molecules."

The sustainability strategy adopted by ICE Pharma is categorized into four core principles: fighting illness through product innovation, caring for people, accelerating sustainable operations, and building strong relationships (1). The company said in the release that these tenets are meant to drive long-term value and bolster resilience, incorporating essential environmental, social, and governance characteristics.

“We believe our sustainability strategy will enhance the long-term stability of both our business and supply chain, while offering meaningful fulfillment for our employees. It also empowers our customers to continue advancing treatments for hepatic, neurological, and other conditions that benefit from bile acid-based therapies,” said Agostino Barazza, chief executive officer.

At booth 4A41 at CPHI Milan, attendees can experience ICE Pharma’s recyclable booth in action and can also learn about the company’s Biliary Acid Library and other innovative products. Attendees will have opportunity to connect with the company’s experts about the future of bile acid-based pharmaceuticals (1).

1. ICE Pharma. ICE Pharma Brings Pioneering Solutions to CPhI Worldwide 2024. Press Release. Sept. 25, 2024.

Centering Sustainability and Environmental Impact in the Supply Chain.

The stand at booth 4A41, carried over from last year in Barcelona, will be constructed of white honeycomb cardboard and linoleum, with material waste generated during production repurposed into seats and tables.

ICE Pharma Touts Fully Recyclable Booth at Its CPHI Milan Exhibit

IMA Group is readying its exhibit at CPHI Worldwide, occurring Oct. 8–10, 2024 in Milan Italy. In a press release on Oct. 2, 2024, the company announced that the products to be showcased by its divisions and experts will be exhibited at booth 18A1 in Hall 18 for the benefit of potential attendees (1).

The company, headquartered in Bologna, Italy, focuses on new and innovative technologies for processing and packaging of pharmaceutical, biomedical, and nutraceutical products in general, but with particular interest in the personal and home care and toiletry sectors (1).

The IMA Life division—which calls itself the “aseptic processing & freeze-drying solutions” division—includes in its portfolio products to process liquids and powders in aseptic and non-aseptic environments, and will present INJECTA 36, an advanced, robotic fill/finish solution aimed at raising the standard for high-speed processing of ready-to-use syringes (1). INJECTA 36 allows for 100% process control and check-weighing in the interest of maximizing production performance. The product received a Best in Show award at INTERPHEX 2023 in New York City.

IMA Group’s solid dose solutions division, IMA Active, will oversee a space dedicated to continuous manufacturing, which the company said enhances the potency, effectiveness, and safety of pharmaceutical products (1).

IMA Safe, which deals with packaging solutions, and IMA EOL (end of line) will be handling the bulk of IMA Group’s numerous sustainable packaging solutions to be shown at the conference. The company said these two divisions will be introducing a “new frontier” of pharmaceutical green packaging, and applications for recyclable and biodegradable films, sustainable plastics, paper, and other materials (1).

There is a new medical device division within IMA Group, IMA MED-TECH, which itself is a business unit of IMA AUTOMATION. This division will have experts on hand at CPHI Milan to offer their insights about assembly solutions for medical technologies—injectors, inhalers, wearables, contact lenses, tubing sets, surgical instruments, and pharma caps among them (1).

In May 2024, IMA Life North America broke ground on a new 80,000 sq. ft. facility in Tonawanda, NY (2). The purpose of the facility is to increase production of freeze-drying equipment and supplement an existing 60,000 sq. ft. facility. An additional 70 employees were expected to be hired at the time of the groundbreaking.

IMA Group has also been a part of the burgeoning artificial intelligence (AI) revolution and became involved several years before the recent rise of AI. In October 2020, IMA Group entered into a strategic partnership with the software company Neurala to deliver AI solutions for industrial machines. The partnership focused on field testing AI that is used to enable monitoring and glean insights from industrial internet of things (IIoT) systems data (3).

1. IMA Pharma. The IMA Group at CPHI Worldwide, Milan. Press Release. Oct. 2, 2024.
2. IMA Life. Groundbreaking Ceremony for IMA Life North America in Tonawanda, USA. Press Release. May 16, 2024.
3. Neurala. Neurala Announces Strategic Partnership with IMA Group to Accelerate AI Technology for Industry 4.0 Initiatives. Press Release. Oct. 20, 2020.

The group’s IMA Life division will present a robotic fill/finish solution that was awarded Best in Show at INTERPHEX 2023.

IMA Group Previews Its Showings Set for CPHI Milan

AAPS PharmSci 360 2024: Drug Delivery in Early Development

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, UT, 

® sat down with Erica Schlesinger, vice president of Technical Development at Serán Bioscience, to talk about her prologue for AAPS PharmSci 360 2024 and what drives the choice of delivery method for new modalities.

“[A]s biologics have emerged as one of the more common therapeutic areas, we've really been looking at how we can improve the patient experience and make these more widely applicable and safer to administer. And a lot of that focus is on how to convert from IV [intravenous] formulations to subcutaneous formulations and subcutaneous administration. And you know, in order to do that, we need to be able to deliver more drug in smaller volumes or more drug in systems that don't need to be administered through IV,” says Schlesinger in the interview. “I think the other area that's been a huge focus area in the past couple years has really been looking at how we can deliver biomolecules and other low-permeability pharmaceuticals systemically through the oral delivery route by leveraging permeation enhancers.”

Click the above video to watch the full interview.

prologue presentation can be accessed from the AAPS PharmSci 360 website

. She will also be moderating the presentation, 

Assessment of Permeability: Bridging Traditional and Novel Compounds in Discovery

, at AAPS PharmSci 360, on Monday, Oct. 21, 2024 in Salt Lake City, UT.

Pharmaceutical Technology sat down with Erica Schlesinger, vice president of technical development at Serán Bioscience, to talk about her upcoming presentation at AAPS PharmSci 360 2024, “High Dose Subcutaneous Delivery of Protein Therapeutics.”

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Ashland, an additives and specialty ingredients company, will be showcasing its oral solid dose (OSD) ingredients at two tradeshow events in October 2024: CPHI Milan and AAPS PharmSci 360. Specifically, the company will be highlighting its new low-substituted hydroxypropyl cellulose (hpc) and its improved polyplasdoneLN superdisintegrant.

The company’s new low-substituted hpc, klucel ls, an OSD excipient, is a multifunctional binder and disintegrant for the formulation of smaller tablets. According to the company, klucel ls “offers quick disintegration and rapid dissolution, anti-capping effect, ease of adoption (as a monographed ingredient), and enhanced stability (non-ionic and low nitrite levels). It is also biodegradable (as a non-microplastic disintegrant)” (1).

Klucel ls adheres to low-substituted hpc monograph requirements and “has fewer hydroxypropoxy groups on the cellulose backbone. This lower substitution results in physical chemical properties that differ from traditional klucel grades, including insolubility in water (as klucel ls low-substituted hpc absorbs water and substantially swells in volume enabling rapid tablet disintegration—unlike klucel, which is soluble in water and used primarily as a binder in oral solid dosage forms),” the company stated in the press release. The excipient is one in a series of future low-substituted products the company has planned.

“As a company rooted in science and innovation, the drive to find ingenious solutions applied to chemistry is in our DNA,” said Deneen Law, global strategic marketing director—Klucel, Ashland, in the press release. “We thrive on developing solutions to complex problems through a collaborative approach that offers the features and benefits our customers require, with the dependability and quality they demand. The removal of single-source global supply for low-substituted hpc and the production of consistent, high-quality products are just a few reasons why Ashland’s customer-centric approach is driving success across diverse industries.”

“Klucel hpc formed the basis of a new generation of oral pharmaceutical dosage forms, and the scientists at Ashland continue to innovate and develop new hpc products to meet the needs of the pharmaceutical industry. While klucel ls low-substituted hpc is part of the klucel brand family, it is not the same as klucel hpc,” Law concluded.

The klucel hpc for pharmaceuticals portfolio includes:

binders: klucel ef hpc; klucel elf hpc; klucel exf hpc; klucel exf ultra hpc

multifunctional binder and disintegrant: klucel ls low-substituted hpc

CR polymers: klucel gxf hpc; klucel hf hpc; klucel hxf hpc; klucel lf hpc; kucel lxf hpc; klucel mxf hpc; klucel xtend hpc.

At the tradeshows, Ashland will also be reintroducing its high-purity crospovidone, polyplasdone LN superdisintegrant, which has nitrite levels at no more than 100 parts per billion to minimize the risk of N-nitrosamine forming in OSD formulations that contain crospovidone.

“We are thrilled to lead the industry with this significant advancement, our commitment to quality and safety is at the forefront of everything we do,” said Alejandra Alvarez, global strategic marketing director—Vinyl Pyrrolidone and Derivatives, Ashland, in the press release. “By providing detailed nitrite specifications, we are empowering our customers to make informed decisions and enhance their own quality control measures.”

Ashland may be found at CPHI Milan, in Milan, Italy, from Oct. 8–10 at booth 6D20 and at AAPS PharmSci 360 at booth 1903 in Salt Lake City, Utah, from Oct. 20–23.

1. Ashland. Ashland to Showcase New Pharmaceutical Oral Solid Dose Excipients at CPHI and AAPS. 

The company will be introducing its new low-substituted hydroxypropyl cellulose and its improved polyplasdone LN superdisintegrant at the October 2024 events.

Ashland to Exhibit Excipients at CPHI Milan and AAPS PharmSci 360

Feliza Mirasol is the science editor for 

On Oct. 1, 2024, SGD Pharma, a global provider of pharmaceutical glass packaging solutions, announced that it plans to exhibit an innovative range of products and services at CPHI Milan in Milan, Italy, from Oct. 8–10. As part of its exhibition, the company will introduce its siliconized molded glass vials. The company’s siliconization process is an internal treatment that provides additional functionalities to a glass vial, according to a company press release.

The internal silicon coating provides protection for sensitive, aggressive, and viscous drug products. In doing so, the coating reduces interactionwiththepackagingandpreservesdrugproductintegrity, according to the press release. SGD stated in the release that siliconizationisavailable for all glass types and for vials ranging in size from 3 mL to 500 mL, both clear and amber glass. The siliconization processissuited toallroutesofadministration, including parenteral,oral, andnasal administration.

“SGDPharma’s €5 million [US$5.5 million] investment in the siliconization production line at its state-of-the-art Saint-Quentin Lamotte(SQLM)plant [in France]enablescustomerstoreceiveordersofhigh-performancevialsatspeed meeting global demand,” the company stated in its press release.

The growing demand for the approval of biologics as well as new therapeutic approaches and the development of specialty drugs is driving the need for ready-to-use (RTU) packaging, SGD Pharma said in its press release. The company offers a RTU solution in molded glass, which includes its Sterinity EZ-fillvials (aregisteredtrademarkofStevanatoGroupand/oritsaffiliatesinoneormorejurisdictions). The Sterinity EZ-fillvials are designed for the rigorous requirements demanded by the pharmaceutical industry. The increased quality and flexibility of these vials enable the shortening of time-to-market and reduce total cost of ownership, according to the press release. Sterinity is suitable for various applications in veterinary and human health.

“AtCPHI2024,weareshowcasingsolutions developedwithourpharmaandveterinarycustomers’needsinmind,aimedatenablingthem tobringtheirdrugstomarketquicklyandsafely.Thiscommitmenttoinnovationisreflectedby our dedication to sustainability, which is an integral component of our company strategy. As we support theUNGlobalCompact forthefifthconsecutiveyear, we are particularlyproudof our progress in reducing carbon emissions at our global glass manufacturing sites,” said OlivierRousseau,CEO,SGDPharma,in the release. “SGD Pharma’s renewable energy initiatives, including the upgrade of our furnace at Saint Quentin Lamotte (SQLM) in France and the installation of solar panels at our Vemula, India, plant, underscore an overarching focus on decarbonization with the company-wide goal to cut emissions recorded in 2020, by 35% by 2030, and by 65% by 2040. These efforts reflect our responsibility to our customers, partners and the planet as we strive for a safer and healthier environment.”

The company will present an extension to its Sterinity range at CPHI, including the debut of aRTUTypeIImoldedglassvial. Sterinity RTU in Type II is expected to initially be available in size 10H, and an extendedrangeofsizes is expectedto launch during2025. SterinityTypeIiscurrently available in sizes 10 mL, 20 mL, 25 mL, 50 mL, and 100 mL. Type I is available in both clear and amber glass.

In addition, SGD Pharma will present an extension to its IDENCY range that includes 20 mL and 6 mL sizes. The company will also introduce new caps for its Ensiemo syrup bottles. The presentation will include the following:

IDENCY, a Type I glass vial that combines the benefits of both molded and tubular technologies, for parenteral sensitive drugs.

Ensiemofull packaging solution, apharma-grade TypeIII glass vialand pipette, which is now available with polypropylene or polyethylene caps for a tamper evident and child resistant closure.

The company now offers LabServices, an analytical testing service in molded glass for its customersandpartners (1). Through this service, experts at SGD Pharma’s SQLM plant provide analytical testing for pharma and biopharma companies, contract manufacturing organization and contract development and manufacturing organizations, and other glass manufacturers. The company expects to launch more LabServices in 2025.

The showcase will be held at SGD Pharma’s booth, 20B11, during CPHI.

1. SGD Pharma. New Labservices for Pharmaceutical Molded and Tubular Glass, Available Exclusively to SGD Pharma Customers and Partners. 

As part of a range of sustainable products and services that SGD Pharma plans to showcase at CPHI Milan, the company will introduce its siliconized molded glass vials.

SGD Pharma to Introduce Siliconized Molded Glass Vials at CPHI Milan to Showcase Sustainable Packaging

Sexy Science in Pharmaceuticals: Hot-Melt Extrusion

Traditionally, hot-melt extrusion (HME) is co-located with downstream processing and solid-dosage form manufacturing. Regulatory bodies continue to encourage quality-by-design (QbD) approaches, quality management maturity (QMM), and process analytical technology (PAT) improvements. These are all essential tools in a well-organized HME platform and work together to enhance product outcomes, but also to improve process understanding. HME, as an approach, is aptly suited to this framework.

As molecular diversity ramps up, the total number of difficult-to-formulate drugs poses severe manufacturing challenges.Creativity, innovation, and bringing in material science practices from other fields seems a fruitful approach.

“Approximately 30–40% of all marketed drugs have low solubility (BCS Class II and IV). Overall, it is estimated that up to 90% of small-molecule APIs in development face solubility challenges; as such, solubility enhancement approaches are critical for the successful advancement of therapeutics that have yet to reach the market” (1).

This episode of Sexy Science in Pharmaceuticals brings together two world-class scientists to discuss one of the top solutions for low solubility. For bioprocessing and manufacturing larger molecules, low solubility and protein aggregation also needs addressing, as does dedicated storage and handling throughout. We discuss these challenges and cite several paths around or through these issues.

As an opening introduction to this discussion, we examine the general aspects of HME supporting bioavailability enhancements for poorly soluble BCS class 2 and class 4 compounds. Examples discussed include Noxafil, an oral suspension used in adults and children to help prevent or treat fungal infections from widespread dissemination throughout the body (also used to treat a fungal infection called “thrush” caused by 

in the mouth or throat area), and Belsomra for insomnia.Both products are part of the Merck portfolio.

In this part of the discussion, a robust processing space to obliterate crystalline structures to create a single-phase homogenous solid amorphous dispersion is defined. Also, we draw up a more green sustainable future without high solvent use and disposal—HME not requiring large volumes of acetone, in contrast to spray drying dispersion processing. In HME, as the temperature rises beyond the glass transition temperature for that material the polymer becomes a liquid. The drug solubilizes into that molten phase. So, we have now a liquid phase that has dispersed drug crystals, which over time break down in the extruder, dissolve, and diffuse into that molten matrix to create a single molecularly dispersed phase. We then use X ray diffraction to look for (hopefully) the absence of crystalline peaks associated with the API. 

In another quality check to see if we’ve been successful, we use differential scanning calorimetry where we want to see a single glass temperature observed in the material, thus showing we’ve also eliminated drug rich domains.

In this part, we discuss HME biological macromolecules for slow release subcutaneously implantable vaccine delivery and injection molded microneedle patches. Aggregation in proteins and frailties of virus like particles leading to inhomogeneity needs to be addressed.

The commercial philosophy of spray dying in early R&D stages, then switching to HME for commercialization is outlined in this discussion. In general, looking at mixing and quenching.Dealing with whole bacterial spore cells extruded into polymer matrices to degrade polyurethanes (in environmentally friendly and sustainable ways), in collaboration with BASF, is also described.

1. Merck. Enhancing API Solubility During API Processing and Formulation Development. eBook, PharmTech.com Oct. 26, 2023.

Professor Jonathan Pokorski, Department of Chemical and Nano Engineering, UC San Diego Jacobs School of Engineering

Professor Pokorski’s laboratory works to bridge chemical synthesis, molecular biology, and materials science to make new materials for biomedical applications. The Pokorski lab is particularly interested in marrying protein and polymer science to generate new materials for drug delivery, imaging, and vaccination. Pokorski received his doctoral degree in organic chemistry from Northwestern University in 2007, where he designed, synthesized, and tested diverse peptidomimetic systems for use in medical diagnostics and therapeutics. Following his PhD studies, Pokorski moved to The Scripps Research Institute, where he used both chemical and genetic engineering of viral nanoparticles to synthesize novel drug delivery systems. During his postdoctoral training, Pokorski first earned an NIH Ruth Kirschstein fellowship and later secured an NIH Pathway to Independence Award.

Prior to his appointment at UC San Diego in 2018, Pokorski began his independent career as an Assistant Professor at Case Western Reserve University in the department of Macromolecular Science and Engineering. Pokorski was a finalist for the prestigious John Diekhoff graduate mentoring award at CWRU from 2013 to 2017, was named an ACS PRF new investigator, and is a Kavli fellow. Research in the Pokorski lab is funded through grants from the National Institutes of Health, National Science Foundation, and the American Chemical Society.

Dr. James DiNunzio, Senior Principal Scientist, Merck

Dr. James DiNunzio is currently a Senior Principal Scientist at Merck & Co., Inc. in Rahway, NJ where he heads the Hot-Melt Extrusion Subject Matter Expert Network Team and co-leads the Continuous Processing Technology Development Team.Since joining Merck in 2013, he has contributed to multiple programs in the disease areas of oncology, virology, and CNS (central nervous system) disorders.Prior to Merck, he served as a Senior Scientist in the Pharmaceutical & Analytical R&D group at Roche where he was responsible for the formulation design of poorly soluble compounds using enabled technologies.He has also held positions of increasing responsibility at PharmaForm and Forest Laboratories.

Dr. DiNunzio received his PhD in Pharmacy (Pharmaceutics) from The University of Texas in 2009 specializing in thermal manufacturing of amorphous dispersions.He also holds M.S. and B.S. degrees in Chemical Engineering from Columbia University and The State University of New York at Buffalo.He currently serves on the Editorial Advisory Boards of AAPS 

.He has authored over 25 research papers and book chapters in the field of hot-melt extrusion and formulation design for bioavailability enhancement.His current research interests include formulation design for bioavailability enhancement, melt extrusion process design for challenging systems, and the development of continuous manufacturing technologies.

This premiere episode of Sexy Science in Pharmaceuticals features Professor Jonathan Pokorski, UC San Diego Jacobs School of Engineering, and Dr. James DiNunzio, Senior Principal Scientist at Merck & Co., Inc. in Rahway, NJ, discussing the benefits of hot-melt extrusion.

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