Outsourced Pharma White Papers

1. 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.

2. Scalable Strategies For Parenteral Dosage Form Selection
   12/29/2017

   Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

    

3. 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.

4. What Clinical Teams Should Know About Changing Trial Logistics
   2/27/2019

   When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.

5. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
   5/30/2019

   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.

6. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes
   4/2/2019

   Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

7. Buffer Management Solutions For Large-Scale Bioprocessing
   2/1/2018

   How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

8. A Common Sense Approach To Sustainability In The Biosimilar Business
   4/2/2019

   Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

9. Is Your Partner Prepared For Your Scale-Up And Commercialization Challenges?
   6/26/2019

   Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.

10. Optimizing Process Efficiency In Upstream Manufacturing
    2/8/2019

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.