Bioprocessing Featured Articles

1. FAQ's: Regulated Films For Containment Solutions 9/11/2014

   At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.

2. Rapid Mycoplasma Testing Service Delivers Speed, Sensitivity And Specificity To A Broad Scope Of Sample Matrices 10/17/2012

   Mycoplasma are the smallest known self-replicating prokaryotes. They parasitize a wide range of host organisms, including humans, animals, plants and insects and are common contaminants of mammalian cell culture. By Dr. Jeri Ann Boose, director, Biopharmaceutical Services, and Dr. Weihong Wang, manager, Molecular & Cell Biology Services

3. Holistic QbD: A Key To Improved Profitability And Sustained Competitive Advantage With Sterile Pharmaceutical Products 8/9/2012

   Pharmaceutical companies are faced with assuring that new quality and compliance paradigms can be met while facilitating profitability to continue adequate business reinvestment. By Fran DeGrazio, Vice President, Global Research and Development, Pharmaceutical Packaging Systems West Pharmaceutical Services, Inc.

4. Ensure Integrity And Prevent Contamination In Single-Use Bags

   As single-use systems continue to gain in popularity, so does the use of single-use bags. A single contract manufacturer can use thousands of bags per year. Gallus Biopharmaceuticals has used over 40,000 bags in just the past decade. Due to the volume increases in some of these bags, the prevention of possible contamination issues has never been more important. More pharma manufacturers are now looking to perform point-of-use tests to ensure the integrity of the bags they are using.

5. Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

   Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

6. Deploying Smart Process Sensors Sensibly

   Today’s demanding biopharmaceutical manufacturing operations require careful control of process conditions, whether during cell culture, purification or drug product formulation. Process sensors play a critical role in enabling high-performance manufacturing by providing real-time visibility into how a process attribute is changing as well as the ability to correlate that change with the stage of the process.

7. Article: How To Choose An Industrial Cation Exchanger For IgG Purification

   Cation-exchange chromatography is the third most used industrial method for antibody purification after anion-exchange and protein A affinity chromatography. It is most commonly used as an intermediate step but continues to attract attention as a capture method. By Pete Gagnon