OP White Papers - random

1. Continuous Flow Manufacturing Of Pharmaceutical Ingredients 11/25/2019

   Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

2. 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.

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

   The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

5. What Clinical Teams Should Know About The Benefits Of Auto-Injectors 8/20/2019

   For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.

6. Utilizing External Collaboration To Accelerate Vaccine Development 11/2/2018

   Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

7. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins 10/2/2018

   This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

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. More Efficient Bispecific Antibody Purification With Fewer Steps 2/28/2019

   A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

10. 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.