Two facilities in Italy and a site in Greenville, North Carolina are being expanded to support demand for biologics aseptic liquid and lyophilized product development and manufacturing. Since Thermo Fisher acquired contract development and manufacturing organization (CDMO) Patheon for $7.2 billion (€6.4 billion) in August 2017, the firm has invested $50 million to double single-use capacity at the St Louis, Missouri biologics facility. Now Thermo Fisher is investing further in the Patheon network through expansions at three global fill & finish…
Facilities & Capacity
New clients and Halozyme drive robust Q3 for Avid
Avid Bioservices has attributed its strong third quarter to the diversification of its customer base and the return of demand from its largest customer Halozyme. When Avid Bioservice became a pure contract development and manufacturing organization (CDMO) in early 2018, it stated the expansion and diversification of its customer base as one of its near-term strategic objectives. A year on and Avid has reported a robust third quarter fiscal year 2019 driven by an increase in the number of manufacturing…
Moderna begins making mRNA cancer vaccine from MA plant
Moderna has successfully transferred personalized cancer vaccine capabilities to its recently opened production facility in Norwood, Massachusetts. In July 2018, Moderna Therapeutics opened a 200,000 square foot clinical development manufacturing plant in Norwood, Massachusetts to support its pipeline of messenger RNA (mRNA) therapies. “Since the site opening, we have successfully manufactured clinical grade mRNA and then moved to formulation and went to filling and finally labeling of our vials,†Stéphane Bancel, Moderna’s CEO told stakeholders during his firm’ recent Q4…
Batch to the future: Amid single-use and 100 g/L, stainless steel will continue to shine
Titers are up and single-use is widespread, but commercial drugmakers will continue to use stainless steel bioreactors for unmet medical needs, GE’s Parrish Galliher told BPI West delegates. Industry convened in Santa Clara, California, for BPI West this week to hear the latest bioprocessing developments and share manufacturing strategies. While much of the attention focused on productivity improvement and disruptive technologies, Parrish Galliher, CTO of Upstream at GE Healthcare Life Sciences and founder of Xcellerex, told delegates not to lose…
CDMO Fujifilm buys Danish plant from Biogen for $890m
Biogen has sold a 90,000 L mammalian cell culture to Fujifilm Diosynth Biotechnologies. The deal propels the CDMO into the top 10 of biomanufacturers based on tank capacity. The manufacturing plant in Hillerød, Denmark will be taken over by contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies, with all the approximately 800 staff members being retained, in the $890 million (€790 million). “The plan is for Fujifilm to use the Hillerød site to produce commercial products for Biogen as well…
Cellectis builds out CAR-T network, creates 200 jobs in NC
Cellectis will build a clinical and commercial production plant in Raleigh at a reported cost of $68 million and a raw material facility in France to support its allogeneic CAR-T pipeline. France-headquartered Cellectis is looking to develop off-the-shelf chimeric antigen receptor (CAR) T-cell therapies using its TALEN gene-editing technology. Cellectis manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMOs) but is now looking to securing inhouse supply through investments in Raleigh, North Carolina, and…
BioVectra: $135m boost for microbial CDMO’s Canadian plants
The Mallinckrodt subsidiary will benefit from a Canadian government grant to help expand microbial fermentation sites in Prince Edward Island and Nova Scotia. In 2014, Mallinkrodt Pharmaceuticals acquired Canadian contract manufacturing organization (CMO) BioVectra as part of its $5.6 billion acquisition of Questcor Pharmaceuticals. The CMO has 64,000 L of fermentation bioreactor capacity across its four manufacturing plants in Atlantic Canada – three in Prince Edward Island and one in Nova Scotia. Now the sites are set to expand through…
Autolus: ‘Fully-enclosed and machine-made’ CAR-Ts to lower COGS
Having begun to build out its CAR-T network, Autolus says its fully contained, semi-automated manufacturing process will increase efficiencies and reduce costs. Last June, Autolus Therapeutics raised $150 million (€132 million) in its initial public offering (IPO) with the intention of using some of the funds to support the manufacturing of its personalized Chimeric Antigen Receptor (CAR) T-cell therapy pipeline. In January, the UK-headquartered firm began building out a commercial manufacturing facility in Enfield, London, and signed a long-term full…
Adaptimmune on the merits of inhouse T-cell production
Adaptimmune says the only way an autologous T-Cell firm can control the evolution of production technologies is to have the process under its own roof. Adaptimmune Therapeutics began working with contract development and manufacturing organization (CDMO) PCT – now known as Hitachi Chemical Advanced Therapeutics Solutions (HCATS) – in 2013 and entered into a five-year strategic partnership in 2016 for the manufacture of its autologous SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell cancer immunotherapies. But the firm has also been…
With Sandoz, Alder confident no supply headache for migraine MAb
Alder BioPharmaceuticals has extended a supply agreement with Novartis subsidiary Sandoz to provide the drug substance for eptinezumab, its migraine candidate anticipated to launch next year. Last Friday, Alder BioPharmaceuticals submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (MAb) targeting the calcitonin gene-related peptide (CGRP), eptinezumab. If approved, the firm expects the migraine prevention candidate to be launched in the first quarter 2020. As such, the firm has secured…