Newsletter | February 19, 2024

02.19.24 -- Overcome Regulatory Challenges Facing CGTs

SPONSOR

As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris.

Sf-RVN Platform

We provide a rhabdovirus-free cell line that improves the safety profile of your bioprocesses combined with a chemically defined medium specifically formulated to get excellent growth and productivity while adhering to evolving regulatory requirements.

Request Information

MilliporeSigma

Preparing Regulatory Marketing Applications For Successful Conclusions

Veristat delivers integrated marketing application (NDA, BLA, MAA, NDS, jNDA, etc.) preparation expertise with a track record of success and achievement of seemingly impossible deadlines.

Request Information

Veristat, Inc.

Powerful Pharmaceutical Batch Management Software

Experion Batch combines distributed control, batch automation capabilities, and innovative visualization technology to provide an optimized solution for a wide variety of batch applications.

Request Information

Honeywell Process Solutions

Clinical And Regulatory Strategy

Novotech is recognized as the Asia-Pacific full-service CRO and has been instrumental in the success of over 1,000 clinical trial projects in key areas such as immuno-oncology, infectious diseases, vaccines, and orphan and rare diseases.

Request Information

Novotech

FectoVIR-AAV GMP

FectoVIR®-AAV GMP ticks all the boxes to make each AAV-based gene therapy a success. FectoVIR®-AAV GMP ensures highest AAV titers with reproducible quality while ensuring maximum process robustness and process safety.

Request Information

Polyplus

Cell Therapy Product Characterization Services

Our cell therapy product characterization services combine rapid PCR, ELISA, and custom methods tailored to these product types from a single contract partner with fully compliant cGMP facilities and options for research grade testing available.

Request Information

Sartorius