Featured Articles

  1. New Biologic Drugs: Regulatory Challenges And Considerations 9/30/2019

    Along the drug candidate development journey there are many regulatory milestones and hurdles. Here are some tips to assist with up-front planning to alleviate headaches down the road.

  2. Scaling A mAb Production Process To A Single-Use Platform 9/27/2019

    The transfer of mAb production processes between scales is difficult. In this study, we leveraged existing physical characterization data and scaled a process from microbioreactor to production scale.

  3. Understanding And Controlling Raw Material Variation In Cell Culture Media 9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

  4. How To Adapt Your Biomanufacturing Process To Maximize Production 7/26/2019

    Today’s novel solutions and technologies can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry. 

  5. Achieving Operational Efficiency In Today's Fragmented Market 7/26/2019

    Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

  6. 4 Steps Toward End-To-End Connected Manufacturing 7/25/2019

    Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

  7. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective 6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  8. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  9. Addressing New Chromatography Challenges With Fiber Absorbents 6/2/2019

    An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

  10. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process.