White Papers

  1. Enhancing Bioavailability When Developing Oral Solid Formulations

    Methods for improving bioavailability are constantly evolving. Selecting the right approach is key to achieving a good formulation that reduces the frequency of dosing and improves patient compliance, as well as results in a low production cost.

  2. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

    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.

  3. Benefits And Challenges Of Driving Modernization In Vaccine Development

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

  4. Biosafety Considerations For Single-Use Bioreactors

    Single-use bioreactors are widely accepted in the pharmaceutical industry and are increasingly being used to perform mammalian cell cultures in commercial manufacturing applications. They address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.

  5. Advanced Digital Sensors Improve Lifecycle Management

    Digital sensors make it possible for the same sensor, lifecycle management software and SOPs to work in both lab and production environments.

  6. Addressing New Chromatography Challenges With Fiber Adsorbents

    A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

  7. CMC Strategies For The Development Of A Bispecific Antibody Platform for Cancer Immunotherapy

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process; therefore, CMC strategies are critical for developing and marketing bispecific drugs. 

  8. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

  9. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

  10. The Importance Of Data Analysis In Solid-State Characterization

    The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.