Expert Insights On Fill/Finish

81. Manufacturing Biotherapeutics Based On Synthetic Biology: Lessons Learned 7/8/2022

    In 2014, Synlogic's co-founders formed the first company that would apply the principles of synthetic biology to the creation and development of biotherapeutics. This article shares their journey in overcoming challenges in producing synthetic biotics, considering new approaches in manufacturing, and the benefits of a hybrid production model.

82. 2022 Outsourcing Trends In Biopharmaceutical Manufacturing 6/15/2022

    The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

83. Biopharma In China: The Emerging Global Force Of Domestic Suppliers 5/23/2022

    Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.

84. Key Considerations For Decarbonizing Your Biotech Facility 5/4/2022

    Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

85. mRNA Vaccines: Key Considerations For Development & Manufacturing 4/4/2022

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

86. The 13-Step Guide For Conducting Cell & Gene Therapy EHS Risk Assessments 3/14/2022

    One of the hurdles for cell and gene therapy manufacturers is the lack of health and safety guidelines. This article summarizes the main steps in a suggested EHS risk assessment process. It can form the basis for discussions between a contract manufacturer and client or between production and development departments. What could go wrong?

87. Single-Use Technologies: A Game Changer For Expanding mAb Production 3/4/2022

    A biotech company that this author worked with had an expanding pipeline and needed to increase its manufacturing capacity, so single-use technologies were implemented from media prep through buff prep, to seed train and through the downstream process. The company saw a dramatic reduction of production costs.

88. 2021's Bioprocessing Year In Review And 7 Key Takeaways 1/11/2022

    The biopharma industry has responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have created the need for new strategies. Explore more in BioPlan Associates’ 2021 18^th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

89. Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon 1/10/2022

    This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

90. How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development 12/22/2021

    Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. Here's how AstraZeneca did it.