Selkirk Pharma is a U.S. based contract manufacturing organization specializing in the sterile fill and finish of injectable drugs, including vaccines and biological therapies. Their state-of-the-art facility in Spokane, Washington boasts cutting-edge technology and recently completed the implementation of 3P^® ENTERPRISE. 

Implementations can be challenging. You need partners that will be there with you every step of the way, guiding you and adapting solutions to fit into your environment. Our expert tells more about our end-to-end approach!

Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology. We spoke with Professor Ding to learn more about her career defining breakthrough to genetically engineer recombinant Factor C, and the importance of creating a sustainable and ethical alternative to replace traditional methods of endotoxin testing. 

Since sterile compounded drugs have a short shelf life, a rapid Microbial detection method like SCANRDI® can reduce the time to results (TTR) from 14-days to as little as 4 hours or less. This helps alleviate the TTR bottleneck in the release process, while still providing a reliable and robust finished-product sterility test.

As health-system pharmacies grapple with ways to address high drug costs, shortages, and labor turnover, many are turning to 503B compounding pharmacies to outsource their compounding needs, reports Pharmacy Times. Subsequently, this is putting pressure on 503Bs to increase capacity and keep pace with demand.

“We show our partners that they can trust us to use all our means possible to achieve the goals that we have agreed on.” - Catherine Bach, Pharma QC Strategic Accounts Director

With a complete portfolio of Quality Control solutions, bioMérieux ensures the safety of patients undergoing cell and gene therapies. - Felix A. Montero Julian, PhD Scientific Director Pharma Quality Control 

Our 3P® ENTERPRISE solution can really make a difference by helping a faster drug release to address the patients’ needs.” - Laurent Leblanc, R&D Manager

By bringing endotoxin testing in-house using the GOPLATE™ and the recombinant factor C (rFC) endotoxin detection assay by bioMérieux, a medical-device manufacturer forecasts a return-on-investment (ROI) in just 11 months and expects significant savings over the next 5 years.

bioMérieux had the opportunity to sit down with Ashley Trueheart, former Director of Product Design and Development at Eagle Analytical (Eagle) to discuss how they provide customers the fastest time-to-results using SCANRDI®, a safe and proven method for sterile product release.

What’s new in the cell and gene therapy landscape? What is the role of quality control in efforts to scale up manufacturing of CGT products and alleviate talent constraints?

The Directorate for Health and Food Safety of the European Commission published the final version of the Annex 1 Manufacture of sterile medicinal products of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.

Cell and gene therapies, also called ‘living drugs’ are both as powerful as they are complex. Despite the impressive trials and life-changing impacts at the individual level, it’s still not possible to manufacture #celltherapies at scales that could benefit a wider range of patients.

Is the future of cell and gene therapy autologous or allogeneic? Which solid tumour may receive the first cell therapy treatment? How will the use of ATMPs in cancer care change our healthcare structures in years to come? Discover all this and more in this podcast with bioMérieux.

Collaboration has been a huge part of the COVID-19 pandemic response, but it is also hugely important in the development of various other therapeutics. In the second episode in our advanced therapy medicinal products (ATMPs) series Jérôme Larghero, Director of the Department of Biotherapies and the MEARY Center for Cell and Gene Therapy in the Hôpital Saint-Louis, AP-HP, and Julien Textoris, Vice President of Global Medical Affairs, Immunoassays and host response at bioMérieux, discuss the importance of collaboration between academia and industry in the development of ATMPs.

In this ‘Experts Interview’ feature published on CELL & GENE THERAPY INSIGHTS, Felix Montero Julian (Healthcare Scientific Director, bioMérieux) and Rey Mali (Vice President Sales and Marketing, Accellix) share their perspectives on current Quality Control challenges and special needs in cell and gene therapy production.

In this podcast, Rey Mali, Vice President Sales and Marketing, Accellix, and Félix Montero-Julian, Healthcare Scientific Director, bioMérieux discuss the difficulties in manufacturing and ensuring the quality of cell and gene therapies, why speed is particularly important in their quality control and some of the key technologies involved in these quality assessments.

In this ‘Ask the experts’ feature published on RegMedNet.com, a panel of key thought leaders share their perspectives on current obstacles and future developments in cell culture and contamination. For example, how can contamination of cell culture affect the final product? What challenges remain in the prevention of cell culture contamination?

Discover the second episode of our Endotoxin Talks video series with Glenn Gauvry, founder of the Ecological Research and Development Group.

Félix A. Montero Julian PhD, Global Scientific Director Healthcare Business talks about the emerging field of ATMP (Advanced Therapy Medicinal Products) and related requirements for microbial monitoring and control.

For this third episode, we had a conversation with Jack Levin, hematologist and inventor of the Limulus Amoebocyte Lysate method for Endotoxin Testing.

The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.

Bacterial endotoxin testing is undergoing dramatic change due to the emergence of recombinant Factor C (rFC) methods – techniques that can increase efficiency and precision compared to Limulus-based reagents.