Author Archives: Millie Nelson

Ins and outs: Changes at Moderna, ReForm Biologics, Daiichi Sankyo

Moderna has appointed executive search firm Russell Reynolds to find Tal Zaks replacement as he steps down from his position as CMO. Meanwhile, there are high level changes at ReForm Biologics and Daiichi Sankyo. Zaks has been chief medical officer (CMO) of Moderna for six years. Now with its first approved mRNA COVID-19 vaccine, Zaks will step down from his position in late September though it is unknown where he will embark on the next leg of his career. Moderna’s…

CDMO quadruples lentiviral capacity on the back of cell gene demand

VIVEbiotech has responded to the high demand for lentiviral vectors in the cell and gene therapy space by expanding its facilities. While no financial details have been disclosed, the Spanish contract development manufacturing organization (CDMO) said it is ramping up its manufacturing capacity and processes enabling it to respond to lentiviral demand. “We are based in San Sebastian in northern Spain, very close to the French border,” a spokesperson told BioProcess Insider. “Our facilities will be increased in around 3,000…

BMS ups Breyanzi production with Massachusetts cell therapy plant

Bristol Myers-Squibb (BMS) will open a 244,000 square-foot cell therapy facility in Devens, Massachusetts expanding its global manufacturing network. The site will initially manufacture BMS’ first CAR T cell therapy, Breyanzi (lisocabtagene maraleucel; liso-cel). The US Food and Drug Administration (FDA) approved the therapy this month to treat patients with relapsed or refractory large B-cell lymphoma. The new facility at the company’s 89-acre Devens campus will be completed in 2021 with commercial manufacturing set to begin by 2023. Previously, BMS…

CDMO to build $490m MAb plant as GSK exits UK site

Lakes BioScience has received permission to begin building a £350 million biomanufacturing facility at a site in Ulverston, UK, currently owned by GSK. Last week, South Lakeland District Council granted permission for Lakes Bioscience, a recently formed biomanufacturing firm, to build a new facility on GlaxoSmithKline’s (GSK) site located on North Lonsdale Road, Ulverston, Cumbria. Lakes BioScience director, Pat McIver told BioProcess Insider it is investing £350 million ($490 million) to build a new site which will produce monoclonal antibodies…

IDT Biologika latest to join AstraZeneca in COVID-19 response

CDMO IDT Biologika will expand its site in Dessau, Germany through a joint investment with AstraZeneca to support the latter’s COVID-19 vaccine. AstraZeneca has signed a letter of intent with contract development manufacturing organization (CDMO) IDT Biologika to help produce its COVID-19 vaccine, AZD1222. Details of the agreement are yet to be finalized, but production of the vaccine is expected to begin at IDT Biologika’s site in Dessau, Germany from the second quarter 2021. However, both companies plan to invest…

Takeda to expand cell therapy facility in Ireland

Takeda has invested €36 million in its Grange Castle facility to support the expansion of its cell therapy manufacturing facility. Takeda Ireland, a subsidiary of Takeda Pharmaceutical Company, said its facility, located about 10km west of Dublin, will become the first commercial-scale cell therapy producton facility in Ireland, following the €36 million ($43 million) expansion.. “The expansion of the cell therapy manufacturing line in Grange Castle will help us to serve more patients worldwide,” a spokesperson for Takeda told BioProcess…

Recipharm expands biologics offerings at German plant

CDMO Recipharm has extended its drug product manufacturing license to include immunology products, expanding its biologics offering. The license applies to the firm’s facility in Wasserburg, Germany. It covers microbiological testing which allows Recipharm to carry out bacterial endotoxin testing on its customers’ products. “Certain bacteria (gram negative bacteria) can release constituents of their cell membrane,” general manager of Recipharm’s facility, Michael Isele told BioProcess Insider. “Bacterial endotoxins can only be destroyed by dry heat exceeding 300°C. Constituents of drug…

Orchard Therapeutics talks the benefits of HSC therapy

Having raised $150 million, Orchard hopes to expand its therapy pipeline into larger indications and says its HSC approach is not limited to the vector it uses. The firm has said the funding will also aid the launch of gene therapy Libmeldy in Europe. Last year, the firm received approval for the one-time treatment which is used to treat children with metachromatic leukodystrophy (MLD). Though often viewed as a single technology, the delivery mechanism, the vector, and the type of…

Ins and outs: High level changes at Merck, Lilly and Editas

Kenneth Frazier will step down from his position as CEO of Merck & Co. and hand over to CFO Robert Davis. Meanwhile, there is high level changes following allegations of inappropriate behavior at Eli and Lilly. Frazier has been CEO of Merck & Co. (known as MSD outside North America) since 2011 and has worked at the firm for almost 30 years. Frazier reflected on the announcement during Merck’s Q4 financial report last week. “It has been a distinct honor…

CGT services round-up: News from Catalent, Thermo Fisher and Aruvant

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…