Skip to main content

Pharmaceutical Quality Control Expert Interviews

SCANRDI

Expert Interview

Why 4 Hours or Less Makes a Big Difference

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.
creating successful and valuable partnerships

Expert Interview

Creating successful and valuable partnerships

“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

bioMérieux ensures the safety of patients undergoing cell and gene therapies

Expert Interview

How bioMérieux ensures the safety of patients undergoing cell and gene therapies

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 

bioMérieux ensures the safety of patients undergoing cell and gene therapies

Expert Interview

Faster drug release to address the patients’ needs

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

lab professional pipetting

Expert Interview

In-House Endotoxin Testing Achieves Strong ROI

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.

Expert Interview

How Eagle’s Approach Gives Its Customers a Huge Advantage

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.

Expert Interview

Evolving QC for Cell & Gene Therapy - What's new in the Cell and Gene Therapy Landscape?

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?

Expert Interview

EU GMP Annex 1 Manufacture of Sterile Medicinal Products Finally Published!

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.

Expert Interview

Podcast: Cell Therapy Manufacture

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.

Expert Interview

Future of ATMPS

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.

Expert Interview

Collaboration in ATMP Development

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.

Expert Interview

Combating Quality Control Challenges and Special Needs of Cell and Gene Therapy Production

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.

Expert Interview

ATMP Manufacturing and QC

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.

Expert Interview

Cell Culture and Contamination

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?

Expert Interview

Endotoxin Talks

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

Expert Interview

What are ATMPs and Why Have They Become a Key Topic of Interest in the Pharmaceutical Industry?

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.
endotoxin-talks_levin

Expert Interview

Endotoxin Talks

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

Expert Interview

Low Endotoxin Recovery

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.

Expert Interview

Advanced Solutions for Bacterial Endotoxin Testing

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.