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1rem

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Review of SUT Adoption in Biopharma Manufacturing

Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.

Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

 Automating the Future of Fill/Finish

In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with Hanns-Christian Mahler, CEO and board member of ten23 health, about the growing demand for fill/finish services, technological advances and novel approaches helping to advance fill/finish, sustainable and green practices, the impact of smaller batch sizes, and regulatory guidance updates in the space.

 holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He previously worked for Lonza, Roche, and Merck, and currently serves on the boards of Bionter and KriyaBio. Hanns-Christian is also an editor for several pharmaceutical journals.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish 

Podcast will explore the technical aspects and advantages of messenger RNA (mRNA) as the basis for therapeutics in cancer treatment as well as vaccines. Based off the success of the mRNA-based COVID-19 vaccines, the biopharma industry is responding with enthusiasm and intense focus on the development of mRNA-based therapeutics for diseases. An area of particular challenge is the delivery of the mRNA therapeutic in vivo. Formulation solutions, such as encapsulating the mRNA within a lipid nanoparticle (LNP) structure, has proven effective. Here, Stefaan De Koker, vice-president of Technology and Innovation, etherna, goes into more detail about the benefits and challenges of developing mRNA-based therapeutics for oncology and vaccines, and discusses the practical application of LNPs toward that goal.

Stefaan De Koker, Vice-President Technology and Innovation, etherna

Stefaan De Koker holds a master in Bioengineering and obtained his PhD at the lab for Molecular Immunology at Ghent University. Throughout his career, he has had a keen interest in understanding how activation of the innate immune system shapes the adaptive immune system and in translating this knowledge into improved vaccines and immunotherapies. De Koker became involved early in the messenger RNA (mRNA) therapeutics field and published seminal papers on the mode-of-action of mRNA vaccines, on the usage of mRNA for intratumoral immunomodulation, and on the development of novel delivery vehicles for mRNA therapeutics. In September 2016, De Kokerjoined ethernawhere he leads the Technology and Innovation team. His focus is currently on the design of customized mRNA lipid-based nanoparticles (cLNPs) for extrahepatic delivery, immunomodulation, and gene editing. De Koker has authored more than 60 publications and is co-inventor on more than 15 patent applications.

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Bourji Mourad, Director of Global Logistics & Partner Management at Sonoco ThermoSafe

 has spent the last 22+ years in the air cargo temperature management and cold chain logistics sector for safer transportation of time and temperature sensitive pharmaceutical products. Bourji is building a global network of stations for handling and repair of Pegasus ULD the first in market with aircraft certified temperature-controlled container as a Unit Load Device launched during 2022.

Bourji is also creating partnerships with selective Airlines and Freight Forwarders at corporate level making it possible for customers gain access to the Pegasus ULD fleet available around the world and offered by Sonoco under a rental program for shipping Pharmaceutical & Life Sciences products. Prior to joining Sonoco in late 2019, Bourji was with Envirotainer for 18 years as their Global Head of Partner Management & Compliance; also has 20 years-experience in the Shipping & Freight Forwarding industry prior to joining Envirotainer.

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.

Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

The trend toward digital transformation in biopharmaceutical manufacturing continues as advanced technologies enter the scene and work their way through to manufacturing operations. With the availability of technologies to take automated biomanufacturing from preclinical to commercial-scale, the industry may start to see a wave of changeovers from manual processes to an automated, digital environment. This episode of the 

Podcast will discuss the realities of switching over from manual to digital, and what to expect.

Ajit Yeole, senior director, Life Sciences Manufacturing, Cognizant

Ajit Yeole is the senior director for Life Sciences Manufacturing at Cognizant, based in London, UK.He is responsible for strategy, smart manufacturing, developing new service offerings, and digital accelerators targeted towards addressing the industry needs. Has been closely working on engagements around manufacturing and quality involving emerging technologies (Industrial IoT, advanced analytics, AR/VR , and others) using agile and design-thinking-led approaches. He has led the manufacturing operations management practice for Cognizant in Europe and has delivered large manufacturing programs while collaboratively building tools and templates for consulting offerings. Previously, he worked in manufacturing operations management, IoT (M2M) and OT/ industrial automation as a consultant, solutions architect, and business unit head.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte

Laks Pernenkil, PhD, is a principal in Deloitte’s Life Sciences Product, Supply, Manufacturing and Quality Operations practice based in McLean, Va. He has more than 15 years of consulting and technical operations experience in pharmaceutical, biologics and medical device sectors. At Deloitte, his experience includes smart/digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence, and market entry operations strategy.

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

Drug Solutions Podcast: Digital Transformation in the Biopharma Industry

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden

President & CEO at Acuitas Therapeutics. 

Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

, chief innovation officer at Maravai LifeSciences has extensive experience and expertise in leading and liaising with multi-disciplinary groups from discovery and R&D to engineering and clinical teams. She brings strong and broad scientific expertise to TriLink Biotechnologies, which covers multiple areas, including gene delivery, medical devices, gene therapies for the treatment of various infectious diseases, cancer immunotherapies and vaccine development. Additionally, she has extensive experience with non-viral delivery systems for a wide range of vaccine targets and cancer immunotherapies.

, president & CEO of Acuitas Therapeutics, is a world-renowned expert in the area of nanotechnology. Dr. Madden co-founded Acuitas Therapeutics in February 2009 and has guided the company into its position as a global leader through the development and application of lipid nanoparticle (LNP) technology. Acuitas Therapeutics partners with leading pharmaceutical and biotechnology companies and prestigious academic institutions around the world, providing its proprietary LNP delivery technology to enable new drugs based on nucleic acid therapeutics.

An mRNA conversation about the recent past, current hot topics, and probable future.

Drug Solutions Podcast: mRNA Past, Present, and Future

In this episode of the Drug Solutions Podcast, Grant Playter, associate editor, speaks with Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, on the history and ongoing development of both protein- and mRNA-based vaccines. Topics of discussion include recent vaccine approvals, the broader state of the vaccine industry, and ideal use cases for both vaccine formulations.

Jeff Fischer, co-founder and president, Longhorn Vaccines and Diagnostics

Jeff Fischer, MBA, is the President of Longhorn and is responsible for oversight of all non-scientific aspects of the organization to include regulatory affairs. Jeff co-founded the company and has served as its Chief Financial Officer from 2007-2017. From 1998-2005, Jeff served as an executive vice president and CFO in the biotechnology industry. He is a former infantry officer in the United States Marine Corps and holds an MBA from the University of Texas at Austin.

Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, discusses the history and ongoing development of both protein- and mRNA-based vaccines.

Drug Solutions Podcast: Evaluating the Vaccine Marketplace

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, chats with Sergey Vlasenko, associate vice-president, Pharma/Biopharma, Agilent, about trends impacting bio/pharmaceutical manufacturing. Sergey provides an overview of some of the key trends and then focuses on a novel modality—oligonucleotides—highlighting the specific challenges related to the manufacture of these exciting therapeutics.

Sergey Vlasenko, associate vice-president, Pharma/Biopharma, Agilent

Vlasenko joined Agilent in 2018 through its acquisition of the privately owned company ProZyme, a developer and manufacturer of glycan reagents, kits, and standards, required for biotherapeutic protein characterization. Prior to ProZyme, Vlasenko managed the R&D and marketing teams developing and commercializing innovative products for the Pharma and Biopharma industry.

In this episode, Sergey Vlasenko from Agilent chats about bio/pharmaceutical manufacturing trends, with a particular focus on oligonucleotides.

Drug Solutions Podcast: Unlocking the Latest Manufacturing Trends

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Hanns-Christian Mahler, CEO and board member, and Andrea Allmendinger, chief scientific officer, both at ten23 health—a contract development and manufacturing organization dedicated to human-centric and sustainable pharmaceutical development—about some of the hurdles facing developers and manufacturers of biological therapies. Hanns-Christian and Andrea take a closer look at some of the solutions being used within industry to overcome these challenges and focus on the issue of sustainability within this sphere. Finally, they touch upon some of the other potentially important future trends that will impact biologic drug development and manufacturing.

Hanns-Christian Mahler is Chief Enablement Officer (CEO) & Board Member, ten23 health

. Mahler’s previous roles include the head of Drug Product Services at Lonza, head of Pharmaceutical Development and Supplies at Roche, and principal scientist of Pharmaceutical Development and CMC Project Manager Erbitux for Merck KGaA. He holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He obtained his venia legendi (German Habilitation) from the University of Frankfurt/M. in 2011. Mahler also serves on the boards of Bionter and KriyaBio, and is an editor for several pharmaceutical journals.

Andrea Allmendinger, PhD, Chief Scientific Officer at ten23 health.

 Dr Allmendinger is also Adjunct Professor and Group Leader at the University of Freiburg (Baden-Württemberg, Germany), researching novel parenteral drug formulations and device solutions to improve stability, usability and cost of goods. Between 2010 and 2021, she was Principal Scientist, Pharmaceutical Development at Roche, working on, inter alia, manufacturability and injectability of high-concentration protein formulations, formulation and process development of freeze dried formulations, syringe and high volume drug/device combination products, particulates and surfactant strategy. Dr Allmendinger studied Pharmacy at the University of Heidelberg, Germany, and University College London, UK, and holds a PhD in Pharmaceutical Sciences from the University of Basel, Switzerland. She obtained the venia legendi (German Habilitation) from the University of Freiburg in 2021, and serves as Editor-In-Chief for the AAPS Open Journal.

In this episode, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, about point of care, patient manufacturing, and new innovative technologies in the industry.

, is the Director, Science Staff in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research at the FDA. Dr. Fisher focuses on engaging FDA stakeholders and supporting advanced pharmaceutical manufacturing technologies. At the FDA, he has served as a primary and secondary reviewer of Abbreviated New Drug Applications (generics) and Drug Master Files, a Team Lead, a subject matter expert on complex drug substances and advanced biomanufacturing, and a liaison to the United States Pharmacopeia BIO1 Expert Committee. He joined the FDA in 2014 as a chemical engineer with expertise in the synthesis of biomolecules. Dr. Fisher’s work prior to joining the FDA focused on the microbial production of proteins and glycoproteins. Dr. Fisher was the co-founder and Chief Science Officer of a startup company focused on microbial technologies for the production of glycoproteins. He earned his B.S. degree at the University of Maryland College Park (Chemical Engineering) and his Ph.D. at Cornell University (Chemical & Biomolecular Engineering).

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: FDA Speaks About Near Patient and Continuous Manufacturing 

PR agencies perspectives lightening round: buy/hold/sell on mRNA beyond Vaccines, Organ on a chip, Artificial Intelligence (AI) and Machine learning (ML), Viral Vector Yield Improvements, Quality Management Maturity (QMM), Near Patient Manufacturing. The role of a PR agency dissected: are you a coach, a resource, a creative inspiration, a connector, a battering ram, secret sauce, an authoritative stakeholder, experienced guide? How has getting a message out has changed in the last 5 -10 years for pharmaceutical companies. What pharma industry trends do you see as important and want to emphasize, or are simply excited by?

Debra Harrsch, President and CEO, Brandwidth Solutions

Brandwidth Solutions’ holistic approach to scalable, science-focused, and customized marketing starts with in-depth industry knowledge and the full scope of services that enable you to get where you need to go. We speak science®.

Beth Willers, Principal, White Matter Communications

WMC was built to deliver a different type of agency experience to the B2B Life Sciences mark.et. Our focus is on developing quality content while building good habits across the PESO spectrum and making deeper connections both internally and externally to sustain a healthy brand evolution.

Kevin McCarthy, Senior Consultant, Orientation Marketing

Orientation Marketing is a life science and pharmaceutical marketing agency operating within specialist B2B scientific sectors. We help drug, ingredients, packaging, medical technology, contract manufacturing, development and research organisations uncover marketing opportunities to become visible, increase engagement and generate more leads.

Public relations agencies dissect pharmaceutical trends: Brandwidth Solutions, Orientation Marketing and White Matter Communications

Drug Solutions Podcast: Pharma Trends Dissected by 3 PR Agency Luminaries

This article takes a look at the developing use of AI in pharmaceutical development and manufacturing.

How AI is Accelerating Pharmaceutical Development

Sept. 30 marked 61 days since July 31, one day past the timeframe President Donald Trump had set forth for companies to lower prescription drug prices in the United States.

Pfizer Reaches First Agreement with White House on MFN Pricing; Who Will Be Next?

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains 

The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal evidence is lacking, observational findings can influence policy and public perception.

Acetaminophen and Autism: Industry Impacts of the White House Statement

While plastics have revolutionized pharmaceutical packaging, that evolution within the industry has come at a cost.

Microplastics as Vectors of Pharmaceuticals in Ecosystem: A Concern

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

The lifecycle of a drug product doesn’t end once the drug is put on the market. It extends beyond, where real-world evidence from patient use of the product provides data that are often relied on in the continued safety testing of drugs or in the development of new drug products.

“Real-world evidence is part of the pharmacovigilance activities, and these are obviously mandatory for all marketed medicines,” explains Siegfried Schmitt, vice president, Technical, at Parexel. “Real-world evidence collation wasn't really required in the past, but it is now. And, in my opinion, it's very likely to stay, given the benefits that real-world evidence delivers. And so, therefore, the real-world evidence for the product must be gathered for as long as you keep the product on the market.”

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, goes on to explain that data about a product must be collected for the product’s lifetime, because of the potential for unknown side effects once used by patients. “You get indications or side effects, [when] you are in the clinical trials. But then once you open it up to the greater population, and everybody can take the medicine, you get more side effects, because it's going to affect everyone differently.”

What kind of supply chain problems can occur during the transportation of pharmaceutical products?

“We are not talking about a breakdown necessarily,” Schmitt says. “We are talking about facts like we heard of from the news, where, say, in the United States, a whole truck [of product] vanished into thin air. They stole a complete truck. They didn’t just break into a truck and steal something. There are some ports in Europe where you should never, ever transport pharmaceuticals through; they get stolen by default. A lane risk assessment is a necessity to understand ‘how can you transport safely, securely? Where should you, for example, stop your truck overnight? Is it illuminated? Is it secured? Is it just in the backyard of a motel?’”

Click the video above to watch Sue and Siegfried answer the following questions:

My company just launched a novel, small-molecule drug into the market. For how long do we need to gather real-world evidence to monitor its safety and efficacy?

My company is investigating options for a novel cell therapy for the oncology market. How can we leverage real-world evidence from our own research and from post-market drugs already on the market to choose which direction to go in?

We are a drug product manufacturer, and we take supply chain security very seriously. As part of our internal assessment, we have identified transportation as a critical element of the supply chain. We use several third parties for the transport of our goods. What security aspects should we address?

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

PharmTech News

PharmTech Videos

Alvin Jogasuria, ProBio; Matthew Lunning, University of Nebraska Medical Center; and Carl Schoellhammer, DeciBio, go behind the headlines to discuss the need for doing more with less.

Behind the Headlines Episode 25: Major Big Pharma Moves, Pressures of Capital Markets at Intersection with Autologous Versus Allogeneic

Behind the Headlines bi-weekly episodes examine the ongoing trends, factors, and fashions that cause pharmaceutical news to happen. Panelists are a mix of consultants, venture capitalists, scientists, patient advocates, journalists, and editors. Each episode talks about the current of the preceding weeks that are on everyone’s lips but seeks to highlight the more enduring lessons that hide behind these headlines.

In episode 25, Alvin Jogasuria, Head of Marketing, Americas and Europe, ProBio; Matthew Lunning, DO, Professor, University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology; and Carl Schoellhammer, Partner, DeciBio, discuss the need for doing more with less as big pharma consolidates and rationalizes their pipeline. This equates to less waste, duplication, and inefficiency to lower costs, particularly in manufacturing aspects of cell and gene therapy. Layer on this the commercial exigencies of tariffs, Most Favored Nation pricing, rises in raw material and energy costs, and the business need to rationalize supply chain and materials pipelines further increases.

Novartis activity in acquiring Tourmaline Bio for cardiovascular disease treatment (1) and also Monte Rosa Therapeutics for degraders to treat immune-mediated diseases (in a deal worth up to $5.7B) (2) was examined from a portfolio perspective. A Pfizer announcement regarding acquiring Metsera Therapeutics for weight loss treatments with an up to $7.3 billion Metsera buyout (3) was another example of portfolio management via disease that the panel discussed.

Much of the remaining panel time was spent looking at CAR T-cell therapy expanding outside of oncology, as well as other advances in advanced therapy medicinal products, generally speaking, with UNMC patient Jan Janisch-Hanzlik being first in the world to receive a new allogeneic CAR T-cell therapy for multiple sclerosis serving as an example (4).


Novartis Acquiring Tourmaline Bio for Cardiovascular Disease Treatment Pacibekitug

Monte Rosa Therapeutics Announces Collaboration with Novartis for Degraders to Treat Immune-mediated Diseases

Pfizer Doubles Down on Weight-loss Treatments with Up to $7.3 Billion Metsera Buyout

World First: Multiple Sclerosis Patient Treated with Allogeneic CAR T Therapy

Manufacturing

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Review of SUT Adoption in Biopharma Manufacturing