Tim Wright, Editor, Contract Pharma02.08.21
Thermo Fisher Scientific has signed an agreement with cell therapy company JW Therapeutics to ensure non-exclusive commercial access to Thermo Fisher's Gibco CTS Dynabeads CD3/CD28.
The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics' lead product relmacabtagene autoleucel (relma-cel). Relma-cel is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The therapy's new drug application (NDA) has been accepted by China's National Medical Products Administration (NMPA). Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
The CTS Dynabeads platform is part of Thermo Fisher's proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. The CTS product line is a comprehensive portfolio of products designed to work together, from cell isolation/activation and gene transfer to cell expansion, to address cell therapy developers' manufacturing workflow challenges. Thermo Fisher's Gibco CTS Dynabeads provide a scalable platform to streamline therapy development and production while ensuring highly reproducible results.
"As JW Therapeutics progresses through the formal acceptance of a New Drug Application (NDA) for relma-cel, and its commercial plans accelerate, we'll be alongside them ready to rapidly scale," said Mark Stevenson, executive vice president and chief operating officer, Thermo Fisher Scientific. "Our strategy to support partners 'in China for China' ensures that we can provide reliable supply and technical expertise as they scale precision medicines."
Harry Lam, executive vice president and chief technology officer, JW Therapeutics, said, "This partnership is a natural extension of an already strong collaboration. As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients."
The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics' lead product relmacabtagene autoleucel (relma-cel). Relma-cel is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The therapy's new drug application (NDA) has been accepted by China's National Medical Products Administration (NMPA). Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
The CTS Dynabeads platform is part of Thermo Fisher's proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. The CTS product line is a comprehensive portfolio of products designed to work together, from cell isolation/activation and gene transfer to cell expansion, to address cell therapy developers' manufacturing workflow challenges. Thermo Fisher's Gibco CTS Dynabeads provide a scalable platform to streamline therapy development and production while ensuring highly reproducible results.
"As JW Therapeutics progresses through the formal acceptance of a New Drug Application (NDA) for relma-cel, and its commercial plans accelerate, we'll be alongside them ready to rapidly scale," said Mark Stevenson, executive vice president and chief operating officer, Thermo Fisher Scientific. "Our strategy to support partners 'in China for China' ensures that we can provide reliable supply and technical expertise as they scale precision medicines."
Harry Lam, executive vice president and chief technology officer, JW Therapeutics, said, "This partnership is a natural extension of an already strong collaboration. As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients."
