Affinia has signed a multi-year agreement with CDMO Lonza to make gene therapy candidates targeting cancer and neurological disorders. Swiss contract development manufacturing organization (CDMO) Lonza will provide manufacturing services for Affinia Therapeutics for two of its gene therapy candidates targeting metachromatic leukodystrophy (MLD), a rare neurodegenerative disease, and brain metastases secondary to human epidermal growth factor receptor 2 positive (HER2+) breast cancer. Both candidates are based on the firm’s lead adeno-associated virus (AAV) vector, Anc80L65. Anc80L65-ARSA aims to treat…

Ray Kaczmarek, the new CEO of Genezen, figuratively sat down with BioProcess Insider to discuss his strategy and aims for the firm. Sit back, relax, and enjoy this week’s Ins and outs. Kaczmarek has spent the past 20 years in pharmaceutical and biotechnology manufacturing, as well as supply chain operations, serving in senior roles at Trilink Biotechnologies, Nitto Avecia Pharma Services, and Pacira Biosciences. His latest career move takes him to contract development manufacturing organization (CDMO) Genezen, where he serves as…

Sandoz has bolstered  its biosimilar pipeline by entering into a commercialization agreement with Bio-Thera for cancer treatment drug, bevacizumab.    The deal, sees Sandoz (a Novartis division) and Chinese firm Bio-Thera Solutions partner to commercialize BAT1706, a biosimilar of Avastin (bevacizumab) . “We see external collaborations as complementary to our internal programs, with an appropriate strategic balance enabling us to drive patient access by delivering portfolio breadth, balancing risks and costs and positioning us to play a leading role in…

Moderna and non-profit firm Institute for Life Changing Medicines have partnered to develop mRNA-3351 for Crigler-Najjar Syndrome Type 1. Under the terms of the agreement, messenger RNA (mRNA) biopharma company Moderna will licence mRNA-3351 to the Institute for Life Changing Medicines (ILCM) with no upfront fees or downstream payments. ILCM will be responsible for clinically developing mRNA-3351 and anticipates clinical studies to begin in 2022. mRNA-3351 uses the same lipid nano particle (LNP) formulation as the firm’s antibody against chikungunya virus…

Sanofi will grow its regenerative medicine  business through the acquisition of Kadmon, adding FDA-approved stem cell transplant Rezurock to its portfolio.   The deal sees French pharma giant Sanofi pay Kadmon Holdings $9.50 per share in cash, equalling a total equity value of approximately $1.9 billion. “The acquisition supports continued growth of our transplant business and adds a complementary offering that expands Sanofi’s portfolio and leverages the company’s expertise in stem cell transplant,” a spokesperson for Sanofi told BioProcess Insider.…

BioLife will boost its cell and gene therapy offerings by acquiring Cook Regentec spin out firm, Sexton Biotechnologies. BioLife Solutions has purchased the remaining shares of Sexton, a firm that provides manufacturing services for the cell and gene therapy industry, in a deal valued at $24 million. Sexton has two product lines; processing and handling solutions and cell performance supplements, which it uses to support cell and gene therapy production. Its portfolio includes human platelet lysate (HPL) media, a bio-defined…

3i invests in ten23 health, a CDMO focused on developing and commercializing injectable biopharmaceuticals. Private equity and venture capital firm 3i Group has partnered with CEO Hanns-Christian Mahler to form contract development manufacturing organization (CDMO) ten23 health headquarted in Basel, Switzerland. The CDMO will offer drug product development and manufacturing, testing services for sterile pharmaceutical products and formulation development. “ten23 is uniquely positioned to provide holistic design and development services with its differentiated pharmaceutical and application knowhow. ten23 health’s offering…