Bioprocessing White Papers

1. Gene To IND In 12 Months Without Increased Risk 10/22/2020

   With a variety of gene to IND programs on the market, it is important you carefully assess which program matches your technical expectations as well as your risk adversity profile.

2. QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1 10/21/2020

   Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.

3. Multiplexing: Managing Risk With Proven, Single-Use Solutions 10/19/2020

   Typically, demand forecasts for drugs prior to launch reflect a huge range of expectations. This illustrates just how hard it is to forecast accurately. Instead of trying to make better predictions (which will never be wholly accurate nor truly able to remove risk), or erring on the side of overcapacity (which is a drag on ROC), developers and CDMOs should seek manufacturing flexibility.

4. Choose A CDMO Partner That Integrates Market Intelligence For Aseptic Fill And Finish 10/13/2020

   Today, a plethora of contract development and manufacturing organizations (CDMOs) provide aseptic fill/finish services around the world. However, to offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering. 

5. Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products 10/9/2020

   The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

6. Making The Medicine Go Down: Specialized Oral Solids Delivery Technologies 10/7/2020

   Most oral solid formulations are designed to release the drug immediately after swallowing for rapid absorption into the bloodstream. However, some products have been developed to release the drug in a specific way following ingestion and provide a “controlled-release” of the drug products. In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.

7. The Importance Of End-To-End Thinking During Drug Product Development 10/7/2020

   Throughout a drug product development program it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

8. Successful Drug Development With Synthetic Lipids: Critical Aspects And Strategies 10/5/2020

   Lipid-based drug delivery systems offer several advantages, including improving the stability, solubility, bioavailability, and toxicity profiles of active pharmaceutical ingredients (APIs). It is essential to select the optimal lipid excipients with the appropriate characteristics for each specific API and application and to ensure that they can be produced using high-quality production methods that are scalable for GMP manufacturing. Working with the right supplier that offers consistent, high-quality products and has expertise in the drug development process and the regulatory environment is essential for the successful development and commercialization of lipid-based drug products.

9. Counting DNA Molecule By Molecule 10/1/2020

   Digital PCR is an established nucleic acid (NA) quantification technology, which enhances the broad use of PCR across molecular biology laboratories globally through improved precision and accuracy. Organizations that impact the quality of nucleic acid measurement and testing, adopted digital PCR early on and have since been pioneering its use for improved accuracy and precision in NA measurement. Ultimately, this will positively impact the quality of NA measurements generally and, more specifically, clinical NA testing. Molecular counting of nucleic acid molecules is the next measurement paradigm.

10. Cell Therapy Scale-Up Strategies For Commercial Success 9/30/2020

    To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.