Culture Development Featured Articles

1. A New Cost Paradigm For CAR Cell Therapies? 6/12/2020

   Hear from Acepodia CEO Sonny Hsiao about his company's claims that its proprietary approach to conjugating novel natural killer cells could reduce the cost of cellular therapeutics.

2. FUJIFILM Diosynth Biotechnologies Chooses ambr250 System For Optimising Microbial Fermentation 9/16/2014

   TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture and fermentation systems for life science applications, is pleased to announce that its ambr250 automated mini bioreactor system is being successfully used at leading Contract Development and Manufacturing Organisation, FUJIFILM Diosynth Biotechnologies, for optimising their microbial fermentations to accelerate scale-up production of protein-based therapeutics.

3. Synthetic Biologics And FUJIFILM Diosynth Biotechnologies UK Announce Significant Improvement In API Manufacturing Of SYN-004 For The Prevention Of C. difficile 8/28/2014

   Synthetic Biologics, Inc. , a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm), announced recently confirmation of exceptional results from the initial phase of cGMP manufacturing of SYN-004, Synthetic Biologics' proprietary oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infections.

4. ISPE Announces Recruitment Milestone Achieved for Its Quality Metrics Pilot Program 8/8/2014

   ISPE announced today that its Quality Metrics Pilot Program has achieved a major milestone with confirmation of 12 companies and 32 sites participating in the Program, even as recruitment continues. 

5. Scientists ‘Snip’ HIV From Cultured Human Cells 7/29/2014

   Scientists from Temple University reported that they have designed a new approach to remove HIV from human cells growing in culture through genome editing.

6. Stainless Steel Vial Filling System Developed For Use In Vaccine Facilities 7/17/2014

   TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture and fermentation systems for life science applications, recently announced the development of a stainless steel version of the fill-it system, designed for safely dispensing biohazardous materials such as vaccine stocks.

7. Analytical QbD at Teva: Knowledge Is Power Only When You Share It 7/3/2014

   Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

8. FDA Approval Pushes Novartis Into 21st Century Vaccine Development 6/18/2014

   In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.

9. DiscoveRx’s Assay IDs Safety Risks Better Than Animal Testing 5/21/2014

   New research reveals that DiscoveRx’s BioMAP Systems can identify significant drug safety aspects more effectively than animal testing. BioMAP Systems is a novel set of primary human cell and co-culture assays that model disease and pathway biology, which enables scientists to glean the safety and efficacy of drugs and chemicals.

10. GE Healthcare Launches Xuri™ IL-2 Growth Factor For The Reliable Activation And Expansion Of T-lymphocytes 5/14/2014

    Xuri™ IL-2 is a dedicated cell therapy ancillary product for the ex vivo cultivation of T-lymphocytes. Xuri IL-2’s defined level of biological activity removes the need for revalidation of each lot and strongly improves reproducibility, thereby minimizing process development time and improving scale out capacity.