Outsourced Pharma White Papers

1. 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.

2. 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.

3. Flow Chemistry: Scale-Up Solution For Modern API Manufacturing 2/20/2019

   Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

4. Is Your Complex Formulation Process Set Up For Success? 10/1/2019

   Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

5. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics 2/11/2019

   Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

6. Can Your Clinical Supply Chain Pass The Brexit Pressure Test? 3/13/2018

   - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask

7. 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.

8. Cell Therapy Logistics 2/11/2019

   Having a sound logistics strategy to ensure that a living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.

9. Virus Safety For Continuous Processing 9/5/2019

   Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

10. Avoiding Hemolysis Blood Sample Collection Processing 2/11/2019

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.