Production Featured Articles

31. Vaccine Bioproduction: An Industry In The Spotlight 7/6/2021

    The pressure continues for manufacturers to quickly produce approved vaccines in unprecedented volumes. Learn about the challenges of sourcing critical process materials from reliable suppliers, and how consistency and collaboration are required to ensure a reliable supply of bioprocess materials.

32. What You Need To Know About Equipment Qualification (IQ, OQ, PQ) 6/30/2021

    Equipment qualification is a series of inspections, tests, and assessments to ensure that a given piece of equipment is compliant and ensures reliable performance. As a key component of quality assurance, it is critical to consistently producing high-quality products.

33. Streamlining Highly Potent Drug Commercialization 6/23/2021

    Demand for highly potent drug substances and drug products continues to increase. Meanwhile, an overarching trend is the increasing reliance on outsourcing and a growing interest in contract service partners that can provide end-to-end solutions.

34. Data Integrity In Supply Chain Risk Management During Zero Trust 6/21/2021

    Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.

35. From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs 6/9/2021

    The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.

36. Single-Use Technology For The Most Extreme Processes 6/7/2021

    Downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. CPC designers identified a polymer that helped reproduce an AseptiQuik connectors to handle rough downstream chemicals.

37. Qualification Considerations For A “Factory-in-a-Box” 6/7/2021

    The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
     

38. Integrating Design And Industrialization To Optimize Cost, Quality & Time 6/1/2021

    Explore how integrating design and industrialization teams can optimize the cost, quality, and time of developing a novel drug delivery system.

39. Outlook: Biotech In 2021 & Beyond 5/31/2021

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

40. Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations 5/28/2021

    In early March 2021, more than 300 professionals in regulatory, industry, and academic roles attended the USP's virtual Workshop on Therapeutic Peptides and Oligonucleotides. Building on regulatory considerations and control strategies, the workshop explored innovative techniques being used to analyze synthetic oligonucleotides, ensure quality, and reduce waste.