Manufacturing

Chris Spivey is the editorial director of 

Articles

Exagamglogene autotemcel seen as synechdoche.

New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia

Matthew Hewitt is vice-president, technical officer, Cell & Gene Therapy & Biologics at Charles River Laboratories.

Larry Bellot, PhD, is scientific advisor, Cell and Gene Therapy, at Charles River Laboratories.

Chad Andersen is associate director, Manufacturing Sciences & Technology, at Charles River Laboratories.

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

Best Practice Tech Transfer Methods for CGTs

Feliza Mirasol is the science editor for 

Spark Therapeutics and SpliceBio have formed a collaboration to develop a gene therapy that can treat an inherited retinal disease.

Spark Therapeutics Partners with SpliceBio on a Gene Therapy for Eye Disease

The California Institute for Regenerative Medicine has partnered with Forge Biologics, which will manufacture AAVs to help accelerate gene therapy programs in California.

CIRM Picks Forge Biologics as AAV Manufacturing Partner

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Exploring mRNA’s Potential

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

eXmoor pharma Expands into Full-Service Cell and Gene Therapy CDMO Partner with Opening of GMP Facilities 

The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Gritgen Therapeutics Launches Commercial GMP Facility in China

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The program will improve access to adeno-associated virus gene therapy vectors.

NIIMBL Launches Viral Vector Program

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

CTMC Partners with ScaleReady for Combatting Manufacturing Barriers

Brian Greven is senior director of Quality & Validation at Matica Bio.

The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.

Manufacturing, Gene Therapies