Diane McCarthy

May 31, 2024 | bioprocessintl.com | Diane McCarthy |Brian Gazaille |Tim Moore |Mark W. Frohlich

Allogeneic cell therapy has become an entrenched concept in the biopharmaceutical industry. Despite clear successes for autologous therapies, especially those based on chimeric antigen receptor (CAR) T cells, cell-therapy companies have yet to devise scalable means for making drug products based on cellular material from and for individual patients. Thus, many cancer patients are left without access to potentially life-saving treatment.

May 31, 2024 | bioprocessintl.com | Diane McCarthy |Brian Gazaille |Mark W. Frohlich |Tim Moore

Allogeneic cell therapy has become an entrenched concept in the biopharmaceutical industry. Despite clear successes for autologous therapies, especially those based on chimeric antigen receptor (CAR) T cells, cell-therapy companies have yet to devise scalable means for making drug products based on cellular material from and for individual patients. Thus, many cancer patients are left without access to potentially life-saving treatment.

Apr 22, 2024 | outsourcedpharma.com | Diane McCarthy |Li Jing |Martin Gonzalez |Martín González |Louis Garguilo

Webinar: Innovative Analytical Strategies to Address Common Development Challenges of New Molecular FormatsComplex next generation biological molecules are becoming increasingly prevalent in today’s biopharmaceutical manufacturing landscape. Through case studies, this webinar will highlight innovative analytical strategies designed to address common challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs and diverse post-translational modifications.

Apr 15, 2024 | outsourcedpharma.com | Diane McCarthy |Li Jing |Andrea Rabellino |Apurv Puri |Louis Garguilo

Four Steps To Identifying The CDMO Proposal Worth SigningTransparency and communication are essential to the success of a manufacturing partnership. If a CDMO is unwilling to have frank conversations during the proposal phase, that’s likely a red flag. The right partner’s team will help you make educated choices while ensuring quality, reasonable costs, and timeline efficiency. When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis.

Apr 10, 2024 | bioprocessonline.com | Diane McCarthy |Li Jing |Jared Clinger

FOCUS ON DOWNSTREAM MANUFACTURINGUSP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>. Pipetting Procedures And Tips To Run An Accurate AssayLearn about Limulus amebocyte lysate assays, steps of the pipetting procedure, and tips to follow in order to deliver consistent and reliable results.