Featured Bioprocessing Editorial

31. Congressional Changes For Orphan Drug Approvals? 4/18/2023

    Lawmakers are stepping in to increase the number of rare disease and orphan drug experts who sit on advisory committees. As it stands now, advisory committees can include experts who simply have a broad understanding of the overall disease state.

32. 4 Risk Mitigation Strategies For mRNA Production 4/17/2023

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

33. The Global Market For Generics & Biosimilars Through 2032 4/14/2023

    According to new market research from insightSLICE, the global market size for generic drugs (including biosimilars) was estimated to be $566.85 billion in 2022 and is expected grow at a CAGR of 5.7% from 2023 to reach a value of $990 billion by 2032. This article shares key insights from the market research.

34. New DSCSA Compliance Blueprint Includes FDA & Industry Input 4/12/2023

    Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.

35. Final Guidance Locks In FDA’s Definitions For Suspect And Illegitimate Drug Product 4/7/2023

    With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.

36. Pharmaceutical Company Innovation By The Numbers 4/6/2023

    Clarivate has published its 2023 list of the Top 100 Global Innovators, identifying the companies and institutions globally that have pushed the boundaries of technology and applied knowledge the furthest. To define “innovation” in this context, Clarivate uses global invention data, which includes patent applications and issued/granted patents.

37. Add Biologics Manufacturing Efficiency With Design Of Experiments, Part 2 4/5/2023

    By reducing the total number of experiments, design of experiments methods streamline process optimization. With fewer tests, drug makers can spend less of their budgets on screening and more on process characterization.

38. Forming Meaningful Pharma-Academia Partnerships 4/3/2023

    In large pharma, R&D investment is increasingly expensive. In academia, there is pressure to produce high-profile science for the improvement of public health. Collaboration between industry and academia is key to innovation and addressing the unmet needs of patients.

39. Global Market Outlook For Cancer Biological Therapies 3/31/2023

    Biological therapies have fewer side effects than chemotherapy and can slow down tumor growth and block the spread of cancer. This article shares the global market outlook for biological therapies to treat cancer, including mAbs, cancer growth blockers, cancer vaccines, and more.

40. A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development 3/29/2023

    Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.