OP White Papers - random

1. Small Molecule Impurities: A Control System Design Challenge For ADCs 3/11/2019

   Composed of both antibody and small molecule elements, ADCs have a complex structure from which many different impurities can arise.

2. 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.

3. Can You Afford Not To Outsource Buffer Preparation? 2/6/2020

   The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

4. Developing A Scalable Process For Adenovirus Manufacturing 4/2/2019

   To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

5. Digital Manufacturing Of Biologics 2/19/2019

   In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

6. 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.

7. Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start 4/7/2020

   As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

8. 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.

9. 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.

10. Component Selection: The Key To Your Program Success 10/1/2019

    The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.