2021

Advanced Analytics to Accelerate Development of Genetic Vaccines

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Biopharmaceutical companies are racing to develop vaccines that mitigate the COVID-19 pandemic, taking a wide range of vaccine-development approaches that include traditional modalities and cutting-edge technologies based on DNA and RNA. Vaccine developers are leveraging robust manufacturing concepts and integrated processes to shorten timelines. Advanced analytics also are playing a critical role in ensuring the safety and efficacy of those emerging vaccines. A New Wave of Vaccines Vaccines based on attenuated viruses entail development timelines ranging from four years to…

February 5, 2021

Reacting to a Pandemic: Innovations in Vaccine Development

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Traditionally, viruses for vaccines have been grown in embryonated hen eggs. But new challenges introduced by the COVID-19 pandemic have encouraged and catalyzed innovations in the field of vaccine development. The biopharmaceutical industry has recognized an advantage in mammalian cell-culture systems as promising alternatives to egg-based vaccine production. Cell lines can be cultured to large quantities in bioreactors, allowing for much shorter lead times, a more controlled production process, and a higher grade of reproducibility through standardization. In this article,…

February 5, 2021

January–February 2021: From the Editor

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With this issue, BPI celebrates its 19th birthday. I have pretty much run out of words to talk about the year we all just endured and the changes we’ve had to make in our lives to sustain our families, businesses, and overall mental and physical health. We editors want to respond appropriately to the complex issues currently facing the biopharmaceutical industry. But with so many technologies advancing so quickly, it’s difficult for a (mostly) monthly publication such as ours to…

February 4, 2021

Announcing the Winners of the 2020 BPI Readers’ Choice Awards

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In the fall of 2020, BPI premiered its Readers’ Choice Awards program. Concentrating on articles published from September 2019 through June 2020, with rankings based on digital engagement, BPI staff identified the most popular articles within each of six categories of bioprocess coverage. You ranked those articles in terms of innovativeness, applicability, and presentation. We’re pleased with the turnout and delighted now to congratulate the winners, who were announced first online. Analytical Award BPI congratulates the winner of our Readers’…

February 4, 2021

The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

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The biopharmaceutical industry continues to develop advanced manufacturing processes, systems, technologies, and facilities. Regulations play a significant role in assessing and approving marketing authorizations for drug products that are submitted for approval. The industry and regulators together should form a coordinated, streamlined process that delivers much-needed medicines around the world. Global Complications The complex global nature of biopharmaceuticals sometimes means that progress is not always as smooth as it could be. One main reason is that regulatory agencies often differ…

February 4, 2021

The Green Imperative: Part Two — Engineering for Sustainability in Single-Use Technologies

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In BPI’s June 2020 issue, the first installment of this series introduces the study and implementation of single-use (SU) technology to provide a more sustainable manufacturing environment (1). We presented evidence showing that the economic and social benefits of SU systems currently outweigh the residual environmental risks. Not only is SU technology often a better environmental choice than traditional biomanufacturing options, it also is sometimes the only choice for rapid process design and facility start-up. In situations such as the…

February 4, 2021

Top Trends in Biomanufacturing

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Facing an ongoing pandemic, growing pipelines, and a possible capacity crunch, the bioprocess industry is striving to balance its priorities. Those are some of the key issues to watch according to the 17th annual report and survey of biopharmaceutical manufacturing capacity and production from BioPlan Associates. It includes survey responses from 130 decision-makers (from 33 countries) at both bioprocessing organizations and contract manufacturing organizations (CMOs) and responses from 150 bioprocess industry suppliers (1). Top trends from this report are highlighted…

February 4, 2021

Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures

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The motto of the European Serum Products Association (ESPA) — “Serum Saves Lives†— reaffirms the essential role that animal serum plays in cell-culture–based research and applications to protect the health of both human and animal populations. Animal serum, especially fetal bovine serum (FBS), needs to be available in abundant supply and at affordable prices to medical and veterinary facilities all over the world. With one billion cattle globally, the supply of FBS should be plentiful, but not all countries…

February 4, 2021

Oxygen Control Strategy and Yield of Recombinant Antibody Fragments Produced in Fermentation

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Immunoglobulin molecules are used extensively in therapeutic treatments, diagnostic applications, and fundamental academic research. Traditionally, full-length antibodies and smaller fragments such as the recombinant antigen-binding fragment (rFab) are produced through mammalian cell culture. rFabs also are small enough to be produced in Escherichia coli through fermentation (1, 2). Because disulfide bonds cannot be formed efficiently in the reducing cytoplasm of E. coli, rFabs are supplemented most commonly with a signal sequence that directs them to the more oxidizing bacterial periplasm…

February 4, 2021

Removing Oligomers of a Recombinant Human Therapeutic Hormone:
Evaluation of Chromatographic Options for Effectiveness

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Aggregation is a common cause of protein instability, which renders a biologic product unfit for therapeutic use. Sometimes it is difficult to purify monomeric proteins from oligomers because of similarities in their isoelectric points (pIs). Proteins such as hormones have pI ranges similar to their oligomers and thus can be difficult to separate out using a conventional polishing chromatographic step such as ion exchange. With those pI similarities, removal of oligomers to a considerable extent by ion exchangers can compromise…

February 4, 2021