Author Archives: Gareth Macdonald

FDA: Drug firms using 24/7 production need more viral safety data

The US FDA has urged protein therapeutics makers using continuous manufacturing to take steps to keep products virus free. The regulator made the suggestion in a recent concept paper along with more general advice on how industry can use 24/7 production to manufacture protein drugs more efficiently. Viral contamination is an issue for all biopharmaceuticals made in processes that use mammalian cell lines. The cells contain sequences that can produce potentially harmful virus-like particles that must be removed from the…

eBook: Cell and Gene Therapies —
A 2021 Industry Update

The US Food and Drug Administration (FDA) reports that as of June 2021, 22 advanced therapy products have received regulatory approval in the United States. The first such product gained regulatory approval in 2010. Since then, hundreds of cell and gene therapies have advanced to clinical evaluation, but few products have reached commercial stages — and those that have done so have been hindered by manufacturing problems. In this eBook, writers from the BioProcess Insider and Project Farma analyze trends…

UK group says 3D printed automated control tech can cut mAb production costs

Automation provides a path to cheaper, faster monoclonal antibody (mAb) production says the UK consortium, which is using 3D printing to develop a tech-independent biomanufacturing control system. The consortium – which includes BiologIC Technologies, Biopharm Services, the UK Center for Process Innovation (CPI), Pall and SCIEX – announced the pact in July, explaining the plan is to develop a prototype strategy and overlay it onto an existing, small scale mAb line. BiologIC Technologies’ role is to use its 3D printing technology to develop…

Thermo: Cell & gene therapy key to further growth in 2021

Thermo Fisher Scientific says cell and gene therapy contracting, PPD and ongoing CAPEX investments will drive growth. The tech and services firm outlined its plans during a Q2 call, explaining its belief that the cell and gene therapy sector prompted its recent investment in a manufacturing center at the University of California San Francisco. CEO Mark Casper predicted the partnership would “will lead to new capabilities for our customers and ultimately better outcomes for patients.” He added a desire to…

Ring raises $117m to fund development of anellovectors

“Virome” focused gene therapy vector firm Ring Therapeutics has raised $117 million in a funding round, attracting backing from venture capital funds and existing investors. The Cambridge, Massachusetts biotech announced completion of the series B fundraising round in July, explaining it will use the proceeds to further develop its range of vectors that are based on anelloviruses. CEO Tuyen Ong said. “With this funding, and the partnership of an exceptional group of investors joining us on this exciting journey, we…

Thermo takes aim at growing plasmid DNA manufacturing market with new plant

Thermo Fisher Scientific has set out to capture a larger share of the growing DNA therapy and RNA vaccine market with a new facility in California. The facility – a 67,000-square-foot facility located at Thermo’s Carlsbad campus – will supply plasmid DNA for drug candidates in clinical trials as well as commercial supply. The firm cited growing global demand for plasmid DNA-based therapies and vital mRNA-based vaccines as the driver for the investment. CEO Marc Casper said, “Demand for commercial plasmid DNA…

Bluebird resumes Zynteglo sales after positive EMA committee review

Bluebird Bio has lifted the voluntary suspension on products containing its Zynteglo gene therapy after the EMA concluded the beta thalassemia therapy’s benefits outweigh its risks. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) published its findings last week, concluding that there is “no evidence” Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML). The EMA wrote “The PRAC reviewed two cases of AML in patients treated with an investigational medicine, bb1111 [also known as LentiGlobin] in a clinical trial for sickle…

US FDA aims to clarify reporting rules for biologics CMC changes

Biologic drug makers that tweak manufacturing processes after approval have a better idea of when and how to inform the US FDA of the changes thanks to new agency guidelines. The US regulator issued the final guidance document last week, explaining the aim is to help biologics makers determine which reporting category is appropriate for a chemistry, manufacturing, and controls (CMC) change. The guidance – which applies to biologics, vaccines, cell and gene therapies, plasma-derived medicines but not whole blood…

Eisai and BMS in $650m solid tumor ADC pact

Eisai and Bristol-Myers Squibb (BMS) will co-develop and manufacture MORAb-202, an antibody-drug conjugate treatment for endometrial, ovarian, lung and breast cancers. Under the deal Eisai and BMS will develop and commercialize MORAb-202 in Japan, China and the wider Asia-Pacific region, the US, Canada, the EU the UK and Russia. BMS will develop and commercialize the drug elsewhere. Eisai will remain responsible for the manufacturing and supply of the product globally. BMS will pay $650 million to Eisai including $200 million…

Vor building cell therapy plant to support clinical trials

Vor Biopharma plans to build a cell therapy manufacturing facility to make supplies for clinical trials. The facility – at Vor’s Cambridge, Massachusetts headquarters – will make hematopoietic stem cell and chimeric antigen receptor T-cell (CAR-T) candidates for trials. Construction is expected to complete in 2022. According to Vor, positioning all its production processes under one roof will reduce production costs and accelerate timelines. The firm told BioProcess Insider: “By integrating its internal research, process development, analytical development, manufacturing, and…