Manufacturing

eBook: Drug-Delivery Devices — Measurement-System Analysis Using Gauge R&R Studies

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When a biological product requires a specialized delivery device, the resulting combination product can introduce new types of quality evaluation. Product development brings together regulatory requirements for biologics and drug-delivery systems, and for many people on the biopharmaceutical side, that includes a number of unfamiliar terms, processes, and procedures. Among those are gauge repeatability and reproducibility studies for measuring variations that arise from measurement devices and the operators using them. This eBook introduces the concept of attribute-data gauge repeatability and…

September 28, 2022

Hardware, Software, and Wetware: 20 Years of Advancements in Biopharmaceutical Production, Part 2

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The past couple of decades have witnessed significant advances in upstream bioprocess technologies and approaches. Since its establishment, BPI has been a facilitator of discussion both in print and at professional conferences, as well as in webcasts and news online. To mark the 20th anniversary of the publication, we surveyed articles published over the past two decades and found hundreds that highlight significant advances in both emerging and established themes in biopharmaceutical production: • “hardware” technology (e.g., analytical instrumentation, bioreactors,…

September 28, 2022

Future Supply-Chain Needs for Allogeneic Cell Therapies: Why Strategic Partnerships Are Critical

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Allogeneic products are an attractive option for cell-therapy developers because multiple batches can be manufactured using apheresis material collected from one healthy donor — and because the resulting therapies could be made available as off-the-shelf products. The appeal of this approach is apparent from growth in allogeneic-therapy development. According to the Alliance for Regenerative Medicine, the number of clinical trials for allogeneic cell-based cancer treatments has increased by 30% over the past five years. Early in 2022, allogeneic candidates accounted…

September 28, 2022

Deriving Mesenchymal Stromal Cells from Umbilical Cord Lining and Wharton’s Jelly: A Comparative Study of Extraction Methods and Culture Media

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Mesenchymal stromal cells (MSCs) are multipotent, self-renewing progenitor cells that can differentiate into adipocytes, chondrocytes, and osteocytes (1). Cultured MSCs are plastic-adherent and spindle-shaped, and they express cell-surface markers CD44, CD73, CD90, and CD105, but not CD14, CD34, CD45, CD11b, CD79a, CD19, or HLA-DR (2, 3). First isolated from bone marrow (BM), human MSCs have been investigated extensively in clinical studies. MSCs also have been isolated from adipose tissue (4) and peripheral blood (5). Perinatal organs and tissues such as…

September 28, 2022

eBook: MSC-Derived Extracellular Vesicles Challenges in Production, Scale-Up, and Characterization

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The discovery of extracellular vesicles (EVs) as an intercellular communication medium has led to explorations of their therapeutic potential. EVs constitute a heterogeneous mixture of several different vesicle populations that may be similar in size but different in content, or vice versa. The vesicles can contain RNAs and proteins as well as DNAs and lipids as biological cargoes. Those cargoes can exist either intraluminally within EVs or on their surface, adding complexity to analytical considerations. EVs are classified into subpopulations…

August 29, 2022

The Evolving Manufacturing Landscape: Reflections from PDA President and CEO

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The past 20 years have been a period of rapid change and development in the world and in the biopharmaceutical industry. One of the biggest changes has been the introduction of a pathway for biosimilars in the decade after 2010. Before that, no provision for “generic” versions of biologics existed. The European Medicines Agency (EMA) approved the first monoclonal antibody biosimilar in 2013, and the US Food and Drug Administration (FDA) followed with its first approval in 2015. Those approvals…

August 22, 2022

Biomanufacturing from 2002 to 2022: How Far the Biopharmaceutical Industry Has Come

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It has been two decades since the theatrical release of the first Spider Man film with Tobey Maguire, the euro became the official currency for the European Union, and Anne Montgomery and Cheryl Scott began piecing together the inaugural issue of BioProcess International. In celebration of the 20th anniversary of this staple publication in the bioprocessing arena, we compared products and manufacturing capacity in 2002 with those in 2022 and delved into what has driven the changes that have occurred.…

August 22, 2022

Continuing Commitments to Quality Reflections on Contract Manufacturing Organizations and Success in the Biopharmaceutical Industry

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Nick Green has worked in the global pharmaceutical and healthcare-services industries for more than 35 years, including significant experience with third-party manufacturing of biological products. He currently serves as president and chief executive officer (CEO) of Avid Bioservices, a contract development and manufacturing organization (CDMO) that focuses on biopharmaceuticals derived from mammalian cell cultures. He has held senior leadership positions at several life-science companies. That includes time spent as president and CEO of Therapure Biopharma, Evolve Biologics, and Rhodia Pharma…

August 19, 2022

Taking a Distinctive Path Reflections on the History of Gene Therapy Development

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For the past 20 years, I’ve been a committed and interested partner to developers of cell and gene therapies (CGTs). I’ve participated in the highs and lows of the industry. Initially, we looked to the development of monoclonal antibody (MAb) therapeutics for a roadmap to anticipate what would occur in the CGT field. It was thought that manufacturing processes would consolidate upon a single “winning” platform process and that both scale and productivity would be increased primarily by focusing on…

August 19, 2022

Transfection: Past, Present, and Future

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The science behind transfection spans from calcium phosphate precipitation to newer methods that are easier to perform, more efficient, and consistent. Mirus Bio strives to perfect gene delivery to cells in culture and support different applications within the life sciences community. The company’s capabilities include RNA interference (RNAi), clustered regularly interspaced short palindromic repeats (CRISPR), and viral vector development for cell and gene therapies with the launch of TransIT-VirusGEN GMP transfection reagent and kits for supporting clinical and commercial adenoassociated…

August 19, 2022