2020

Setting a Cornerstone for Platform Purification of Exosomes

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Exosomes are a subject of rapidly growing therapeutic interest in the biopharmaceutical industry for two principal reasons. The first reason is that they are the primary communicators of instructions from source cells to target cells. Exosome surface features define their destination. They recognize complementary features on target cells, dock with them, and deliver their programmed instructions in the form of microRNA. The second reason is that exosomes are immunologically silent. As normal human cell products, and by contrast with gene…

April 13, 2020

Building Orthogonality into Biosimilar Testing

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Both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have developed regulatory guidelines on biosimilars (1, 2). These comprehensive documents provide clear guidance on what the agencies expect from structural characterization studies. Using state-of- the-art instrumentation and techniques is expected, but the use of orthogonal techniques in structural comparability assessments is also required. The application of orthogonal analytical techniques will provide a firm structural foundation to claims of biosimilarity. Characterization methods verifying and supporting conclusions drawn…

April 13, 2020

Brazilian JBS Federally Inspected Fetal Bovine Serum

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Serum is the most commonly used supplement in cell culture. Fetal bovine serum (FBS) is the common choice because it contains high concentrations of growth factors and other important signaling molecules (e.g., adhesion proteins, nutrients, carrier proteins, cytokines, and hormones) required for cell survival and differentiation together with its buffering capabilities. FBS production begins with the collection of whole blood from bovine fetuses under aseptic conditions. Once collected, the blood is allowed to clot, and the serum is mechanically separated.…

April 13, 2020

Developing a Biopharmaceutical Workforce for Today and Tomorrow

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Biomanufacturing is constantly evolving, developing new treatments and therapies through cutting-edge methodologies and facing increasing integration of big data and analytics. But keeping up with innovation in this segment requires a workforce with advanced skill sets. The US State of Rhode Island (RI), with a rich manufacturing history and a thriving biotechnology sector, has taken on that challenge. We are preparing a robust talent pool — the greater Providence area contains over 1.6 million people — to become the highly…

April 13, 2020

eBook: Microbial Expression — The Right Choice for Large Peptides and Small Proteins

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Although animal cell culture has dominated the biopharmaceutical industry for some years now, microbial expression remains important for producing proteins that don’t require posttranslational modifications — or only those that prokaryotic microbes can perform. It also offers an affordable option for antibody fragments and gene therapies. Microbes may be less fragile than animal cells, and they do require simpler media, but they present other challenges related to temperature management and oxygen transfer in culture. Wherever practical, bacterial expression is preferred…

March 31, 2020

A Future-Proof Solution for Bioprocess Applications: The New Eppendorf Flexible Bioreactor Control System Evolves with the Changing Needs of Modern Biotechnology

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In the biopharmaceutical industry’s quality-by-design (QbD) era, optimizing tools for process monitoring and control has become a major focus of development and manufacturing. This increased attention brings challenges into upstream and production processes, cell-line development, process optimization, and scale-up. Suppliers of equipment and technologies also focus on helping their customers improve development timelines. With that increased attention to speed, they are offering tools such as the Eppendorf SciVario twin bioreactor control system to streamline development and maximize flexibility. BPI spoke…

March 3, 2020

March 2020: From the Editor

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My first business trip each year usually is to Washington, DC, in January. There, the CMC Strategy Forum and WCBP symposium (sponsored by CASSS have an excellent track record of setting the stage for topics that will play out through the rest the year. The combined event draws significant US Food and Drug Administration participation. So we also look forward to their help in focusing our attention on key regulatory issues and updates. With continuing focus on well-characterized biologics, WCBP…

March 3, 2020

New Directions in Bioprocess Development and Manufacturing

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The biopharmaceutical industry continues to grow at a rapid pace. That growth is accelerating even more because of keen investor and research interests in cell and gene therapies. My focus below is on several key growth areas in the field, specifically aspects of development and biomanufacturing. This discussion builds on my 2018 column on top trends in bioprocessing (1). In that article, I identified five key trends that continue to resonate now: rapid development of high-productivity upstream processes advances in…

March 3, 2020

Scalable Manufacturing of Lentiviral Gene Therapies

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Lysosomal storage diseases are caused by mutated genes that express defective lysosomal proteins, such as essential enzymes. For example, cystinosis is a metabolic disease caused by a defective gene that encodes cystinosin, an exporter protein (Figure 1). Avrobio develops gene therapies to treat lysosomal storage diseases. On 8 October 2019, the company announced that its first patient had been dosed in the AVR-RD-04 investigational gene therapy program, which involves genetic modification of the patient’s own hematopoietic stem cells to treat cystinosis.…

March 3, 2020

The Next Global Life-Science Leader

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Canada’s life-science industry is exceptional at producing innovative research. With less than 0.5% of the world’s population, our country produces 5% of the globe’s total research publications. Canada’s citation rate ranks among the top six nations and is 43% higher than the global average (1). At the same time, our life-science industry is competing with other global jurisdictions into which investment is flowing. The US state of Massachusetts, already the number one biotechnology cluster in the world, has committed US$1.5…

March 3, 2020