Catalent signs agreement with Trizell, Thermo Fisher Scientific partners with JW Therapeutics and Aruvant chooses Lonza to manufacture a sickle cell gene therapy. Lovely to have you here for BioProcess Insider’s CGT services round-up.
First up in our cell and gene therapy (CGT) services round-up is Catalent, which recently confirmed an agreement with Trizell to support the manufacturing of Trizell’s Phase I therapy to treat micro and macroangiopathies.
The firm’s therapeutic is an advanced therapy medicinal product (ATMP) which uses regulatory macrophages – specialized cells which destruct bacteria and harmful organisms and can present antigens to T cells to instigate inflammation by releasing cytokines to activate other cells.
Image/iStock: stuartmiles99
Catalent boasts a 25,000 square-foot facility in Gosselies, Belgium – added through its acquisition of Masthercell last year – where manufacturing of the cell therapy will take place.
“Extending into areas such as macrophages, allows us to stay on the forefront of emerging indications and cell types,” said Catalent president of cell and gene therapy, Manja Boerman. “The process development, manufacturing expertise, and the experienced production teams we have at Gosselies will enable a faster transition from development to manufacturing.”
Secondly, we have Thermo Fisher Scientific which has signed an agreement with JW Therapeutic to guarantee non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28.
Dynabeads is part of Thermo Fisher’s Cell Therapy Systems (CTS) which is designed to ease the shift from clinical development to commercial manufacturing of T-cell therapies.
The partnership will support the clinical development of Chimeric Antigen Receptor T-cells (CAR-T) in China, this includes JW Therapeutics’ product relmacabtagene autoleucel (Relma-cel). The anti-CD19 CAR-T therapy is expected to be the first CAR-T therapy product to be approved as a Category I biologics in China for relapsed or refractory B-cell lymphoma.
Chief operating officer Mark Stevenson said “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.”
Thirdly, we have Aruvant Sciences which has partnered with Lonza to help develop and manufacture ARU-1801 for its upcoming study.
ARU-1801 is a gene therapy for sickle cell disease (SCD) and the firm said it is administered with one low dose of chemotherapy.
Lonza has already begun process development and tech transfers from its Houston facility to establish and support robust manufacturing for ARU-1801. Lonza will deliver material supply for the pivotal clinical trial when complete.
Aruvant’s chief technology officer, Palani Palaniappan said “Our internal cell therapy process expertise combined with Lonza’s cell processing know-how provide the perfect combination to manufacture ARU-1801 for our pivotal study. As we advance our gene therapy through clinical trials, this partnership signifies a critical milestone in the development pathway.”
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