March 2023 Featured Report

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

Focus on Aseptic Processing: A Report from the September 2022 PDA Annex 1 Event in Amsterdam

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The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include. The Parenteral Drug Association (PDA) has organized a series of four workshops, the third of which took place in…

March 21, 2023

Advances Toward Dry-Powder Formulations for Monoclonal Antibodies

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Therapies based on monoclonal antibodies (MAbs) and other recombinant proteins usually are formulated as aqueous solutions for subcutaneous injection or intravenous infusion. However, as the biopharmaceutical industry amasses manufacturing knowledge and experience with such products, interest is surging for alternative formulation methods. Aerosolizable dry powders for inhalable administration represent a particularly promising option, with potential advantages not only for drug delivery and dosing, but also for patient comfort and compliance with treatment regimens. Previous research into dry-powder biopharmaceutical formulation has…

March 21, 2023

Cryopreserving Hematopoietic Stem Cells — Part 2: Methods, Materials, and Operations

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Bone marrow (BM) remains a critical source of hematopoietic progenitors used in stem-cell transplantation. Currently, however, it is obtained almost exclusively from living donors. That approach limits what quantities of cells can be extracted during an aspiration procedure, in turn reducing the number of opportunities available for treating blood-cancer patients. In BPI’s November 2022 eBook on cryopreservation, I presented part of my conversation with Erik Woods (cofounder, chief science officer, and executive vice president of Ossium Health) about ways to…

March 21, 2023