Author Archives: Cheryl Scott

eBook: Bispecifics — Fulfilling the Promise Through Science and Engineering

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With nine products already on the market, bispecific antibodies (bsAbs) are the most commercially advanced of all antibody-derivative biopharmaceuticals. But that isn’t to say that they face no obstacles to success. Indeed, as BPI’s senior technical editor finds in her review of recent literature and conference proceedings, the details of production and processing still confound many bsAb developers. With dozens of molecular formats in progress — and more arising all the time — the prospects for a platform process are…

May 25, 2023

Introduction: Cell-Line Development Discussions at Biotech Week Boston

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The genetic sequence of the Chinese hamster ovary (CHO) cell line first was published just over a decade ago (1, 2). As with the Human Genome Project, genomic knowledge of that and other biopharmaceutical production cell lines — both animal and microbial — has expanded greatly alongside dramatic increases in computing power (3–5). Meanwhile new and improved genetic engineering techniques have offered the potential for targeted rather than random integration of transgenes into production cells. And regulators began to emphasize…

April 20, 2023

Introduction: Practicalities of Aseptic Processing for Modern Biological Drug Products

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With proliferating modalities entering and moving through the biopharmaceutical industry’s development pipeline, drug presentations are expanding and diversifying to accommodate. Even “traditional” biologics such as monoclonal antibodies (MAbs) have evolved in their formulation and packaging, with the emergence of highly concentrated drug products, prefilled syringes, and devices that enable patients to inject themselves at home rather than visiting a local clinic for drug infusion. Patients, clinicians, and payers are demanding convenience and cost-effectiveness as well as safety, quality, and efficacy…

March 21, 2023

eBook: Monoclonal Antibodies — Reviewing the Past Year in Design, Engineering, Characterization, Manufacturing, and Formulation

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Even as advanced therapies and new modalities grab headlines, the monoclonal antibody (MAb) segment of the biopharmaceutical industry continues to perform, bringing needed treatments for emergent infections, rare diseases, and widespread conditions to patients who need help around the world. In fact, MAbs are at the heart of many emerging therapeutics, including bispecifics/multispecifics, antibody fragments, and antibody–drug conjugates (ADCs). But the original molecular class itself still dominates the biopharmaceutical development pipeline and the interest of biotechnology suppliers around the world.…

February 23, 2023

eBook: mRNA — Negotiating New Manufacturing Hurdles

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The emergency authorization, regulatory approval, and successful commercialization of Pfizer–BioNTech’s and Moderna’s respective mRNA vaccines for SARS-CoV-2 have ignited considerable interest in the modality across the biopharmaceutical industry — and for good reasons. Establishing a platform process for mRNA production could facilitate and accelerate several aspects of vaccine development and manufacturing. Drug makers also intend to leverage benefits associated with cell-free bioprocessing. But as the contributors to this eBook show, mRNA remains a nascent modality, and companies must surmount new…

December 20, 2022

Introduction: Viral Clearance and Inactivation in Downstream Processing

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Viral safety in the biopharmaceutical industry is both an upstream-production and downstream-processing concern. Companies must take a multipronged approach using orthogonal methods that are validated to prevent viral contamination or to remove it from biologic drug products. On the upstream side, the focus is on prevention through risk assessment and mitigation. That begins with environmental control of facilities and includes both careful selection of raw materials and cell lines and preparatory filtration of culture media components. In downstream processing of…

December 12, 2022

eBook: Chromatography Column Packing — Best Practices and Considerations from Laboratory to Manufacturing Scale

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Column chromatography is a powerful separation tool for biopharmaceutical research and industry, with applications ranging from laboratory bench-scale purification to process development and commercial-scale manufacturing of biotherapeutics. Ensuring the highest quality of separations depends on many factors, including the technique used for packing the chromatography column. Well-packed columns provide for the best chromatographic separations. Successful column packing ensures proper mobile-phase distribution and resin contact. Scaling up to large columns can introduce many challenges. Manufacturers of chromatography media provide best-practice advice…

December 5, 2022

September 2022: From the Editor

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Just coming off our big anniversary issue, we editors are still in a taking-stock mindset. That normally goes hand-in-hand with planning for the next publication year — which we can’t believe we’re doing already — but it feels more acute this time. And our 20th year has coincided with some pretty major current events, as the world begins to emerge from a pandemic amid a great deal of associated economic and sociopolitical turmoil. The effects of it all on the…

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

20th Anniversary Issue: From the Editors

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Founded in the middle of 2002, BPI published its first issue in January of 2003. Our 20th-anniversary issue thus takes the form of a state-of-the-early-21st-century industry report. Assembling this content has reinforced our appreciation of the remarkable paths that this industry has taken and continues to take — and our journey alongside it. Having worked as editors in this industry since August 1988 (Montgomery) and September 1996 (Scott), we’ve found it difficult to maintain a chronological grasp of developments —…

August 22, 2022