Author Archives: Millie Nelson

Thermo Fisher invests $154m to expand NC plant

Thermo Fisher will increase manufacturing capacity for fill-finish services at its Greenville, US facility with an $154 million investment.  Bioprocess vendor Thermo Fisher Scientific has unveiled plans to bolster its manufacturing capacity for sterile liquid and lyophilized filling, pre-filled syringes, and solid dose continuous manufacturing at its Greenville, North Carolina facility. The $154 million investment is not part of the firm’s recent $600 million CAPEX plan, which had the trade press salivating in March.  “Our continued growth in capabilities and capacity at our Greenville site has enabled us to support our clients’ needs and…

AGC Bio bolsters pDNA and mRNA capacity with German plant expansion

CDMO AGC Bio will expand its Heidelberg, Germany facility to increase its manufacturing capacities for customer pDNA and mRNA projects. The expansion, of which financial details have not been disclosed, sees contract development manufacturing organization (CDMO) AGC Biologics boost its current production capacity for plasmid-DNA (pDNA) and messenger RNA (mRNA) by adding an additional manufacturing line. The Heidelberg expansion will also include additional warehouse capacity, a cleanroom for mRNA development and production, and a process development lab for microbial protein…

CureVac drops CDMOs but continues COVID-19 vaccine development

CureVac has terminated contracts with two of its CDMOs – Wacker and Celonic – after demand for potential COVID-19 vaccine diminishes. However, the firm remains positive future clinical trials will go ahead. The German biotech entered the COVID-19 vaccine race in March 2020 and began creating mRNA COVID-19 candidate, CVnCoV. The firm quickly struck deals with various contract development manufacturing organizations (CDMOs) such as Novartis, Bayer, Rentschler, GSK, Wacker and Celonic to support production of the candidate. However, just a few…

Affinia strikes strategic AAV manufacturing deal with Lonza

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…

Ins & Outs: Genezen new CEO to lead transition into full service CDMO

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 expands biosimilar pipeline in Bio-Thera collaboration

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 to develop mRNA therapeutic for ultra-rare disease

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 bolsters stem cell biz with $1.9bn Kadmon buy

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 bolsters CGT portfolio through Sexton acquisition

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…

CDMOs snapping up plants – a microtrend in the CGT space?

Various cell therapy firms have sold their inhouse facilities, but is this a trend in industry or just coincidence? While manufacturing outsourcing is a staple part of the biopharma world, over the past few years many advanced therapy developers – including Pfizer, Astellas, Allogene and Regenxbio – have lauded the decision to invest inhouse. Many have cited inhouse capabilities as necessary to keep full manufacturing control over complex processes, while others cite the lack of third-party capacity and long booking…