Author Archives: Gareth Macdonald

US FDA aims to clarify reporting rules for biologics CMC changes

by

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…

June 28, 2021

Eisai and BMS in $650m solid tumor ADC pact

by

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…

June 21, 2021

Vor building cell therapy plant to support clinical trials

by

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…

June 21, 2021

Enzymatic DNA printer will speed R&D and COVID testing, says DNA Script

by

DNA Script has launched a benchtop nucleic acid printer it claims will accelerate molecular biology, genomic research, and even COVID-19 testing. The Paris, France firm unveiled Syntax this month, describing it as a fully integrated, automated printer that is able to synthesize 96 DNA oligonucleotides in parallel, comprised of up to 60 nucleotides in length. The technology uses enzymes to synthesize the DNA molecules which – unlike traditional phosphoramidite chemistry based approaches – accelerates and optimizes production and eliminates the…

June 18, 2021

Avalon to buy China’s Senlang for cell therapy pipeline and manufacturing plant

by

Avalon GloboCare will buy Chinese cell therapy developer Hebei Senlang Biotechnology in a deal prompted by the latter’s pipeline and biomanufacturing capacity. The deal – which will see Avalon issue 81 million shares – will also include Senlang’s chimeric antigen receptor T-cells, allogeneic CAR Gamma Delta T-cells, and armored tumor infiltrating lymphocyte (armTILs) platforms. Avalon will also gain SenlangBio Clinical Laboratory, a subsidiary that provides third-party services. The firm specializes in biochemical, genomic and proteomic testing, cell therapy related analysis…

June 16, 2021

COVID-19 driven CDMO investments to benefit wider sector

by

COVID-19 driven investments in vaccine production capacity will help relieve existing bottlenecks as the pandemic recedes, according to the authors of a new report. Demand for vaccine production capacity increased significantly last year as pharmaceutical industry efforts to develop effective jabs accelerated. The contract development and manufacturing organization (CDMO) sector’s response has been to invest in vaccine and vector production capacity, says Fiona Barry from GlobalData. “We’re seeing very high investment in vaccine-related contract manufacturing, by dedicated CDMOs and by…

June 14, 2021

Back to business? Demand for trials returning, says Icon

by

Icon says demand is recovering with bookings for its own services as well as those of soon-to-be acquired PRA continuing to climb in the second quarter. The Dublin, Ireland headquartered contract research organization (CRO) saw bookings increased 27% in the first quarter, versus the first three months of 2020, with book-to-bill ratio – roughly the value of new contracts divided by revenue – of 1.28. And the momentum has continued, according to CFO Brendan Brennan who spoke at Jefferies’ Healthcare…

June 7, 2021

UPenn gene therapy researchers lease space at Discovery Labs

by

University of Pennsylvania gene therapy researchers have leased space at Discovery Labs’ facility in King of Prussia in a deal designed to expand vector production capacity. The agreement – financial terms of which have not been disclosed – includes two dedicated floors at Discovery Labs’ campus on Swedeland Road. The leased space will house the Penn Vector Core, which is a full-service viral vector manufacturing operation. At present Penn produces viral vectors for use in gene transfer. It supplies vectors…

May 27, 2021

Engineering Alternatives: Modern Technology Enables Expression System Developers to Think Beyond CHO Cells

by , , , and

Major biopharmaceutical companies are teaming up with academics and the Bill & Melinda Gates Foundation to develop new biomanufacturing cell lines and methods. The project — known as the AltHost Consortium — is exploring innovative ways to produce biologics and vaccines for clinical usage in diseases from diabetes to cancer. Lead researcher J. Christopher Love at the Massachusetts Institute of Technology (MIT) likens this precompetitive, open-access collaboration to the early days of the biopharmaceutical industry. “When biomanufacturing first emerged as…

May 24, 2021

Bluebird welcomes CHMP nod for CALD gene therapy

by

Bluebird Bio says Skysona – a treatment for the neurological disease CALD – is a step closer after a thumbs-up from EMA reviewers. The European Medecines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the therapy and issued an approval recommendation last week. The CHMP said the advice was based on a study in which Skysona (elivaldogene autotemcel, formerly Lenti-D) preserved motor function and communication ability and improved survival in 90% of patients…

May 24, 2021