Continuus in $69-M Continuous Mfg Pact; Almac, Adare, Aphena ExpandBy
The latest from CDMOs, CMOs, and suppliers featuring Continuus Pharmaceuticals, Almac, Grand River Aseptic Manufacturing, Adare Pharma Solutions, and Aphena.
Chemicals/Chemical API Manufacturing
Continuus Gets $69.3-M US Gov’t Contract for Continuous Mfg
Continuus Pharmaceuticals, a spin-out founded by scientists involved in a collaboration between the Massachusetts Institute of Technology and Novartis in continuous manufacturing, has received a $69.3 million contract from the US government contract to facilitate domestic production of three medicines, including COVID-19 treatments.
The contract, awarded by the US Department of Defense (DoD) in conjunction with the US Department of Health and Human Services (HHS), will also enable construction a facility for end-to-end, integrated continuous manufacturing (drug substance through drug product production) of small-molecule drugs, including marketed products, generic mand investigational therapies through all phases of clinical trials and a product’s lifecycle.
Continuus will break ground for a new facility in Woburn, Massachusetts later this month (January 2021) and plans to make the plant fully operational within two years
Source: Continuus Pharmaceuticals
Almac Expands Biologics Testing Lab
Almac Sciences, part of the Almac Group, a Craigavon, UK-based CDMO, has invested £500,000 ($686,000) in mass spectrometry equipment to expand its biologics testing laboratory in Craigavon, Northern Ireland.
The new mass spectrometer will support the analysis of peptides, proteins, glycoproteins and antibody products and provides analysis for amino acid sequencing, peptide mapping, disulfide bridge analysis using MS and MS/MS, glycosylation analysis, identification of post-translational modifications e.g. acetylation, phosphorylation in addition to biomarker discovery.
The expansion follows the recent addition of a new biologic testing laboratory, which supports quality control release and characterization of biologics.
Source: Almac Group
Formulation Development/Drug-Product Manufacturing
Grand River Aseptic Manufacturing Invests in Syringe, Vial Equipment
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has invested in additional syringe and vial equipment.
The equipment is scheduled for delivery during the first quarter of 2022. The Bausch+Ströbel filler with SKAN isolator is a duplicate of GRAM’s current vial filler that reached production in September 2020. The duplication will allow experts to qualify the equipment and reach production. Additionally, the VarioSys syringe and vial filler system provides the flexibility to increase production capacity with the option to dedicate complete modules to individual drug products.
GRAM added nearly 100 new employees in 2020 and says it will continue to grow as equipment and facilities expand.
Source: Grand River Aseptic Manufacturing
Adare Pharma Solutions Opens New Small-Scale Lab
Adare Pharma Solutions, a CDMO and provider of pharmaceutical technologies, has opened a new small-scale development laboratory in Vandalia, Ohio.
The new laboratory has smaller development equipment that mirrors Adare’s pilot and production capabilities to enable the production of smaller batches using less active pharmaceutical ingredients and can be used with immediate-release, modified-release, taste-masked, or other custom formulations.
Source: Adare Pharma Solutions
Aphena Nears Completion of $21-M Expansion
Aphena Pharma Solutions, a CDMO and provider of contract packaging services, reports that a $21-million expansion of its site in Cookeville, Tennessee is progressing according to schedule, with a planned completion date of April 1, 2021.
The expansion, which was first announced in September 2020, includes the acquisition of a 500,000-square-foot property that is purpose-built for FDA manufacturing and packaging operations and represents Aphena’s expansion into biologics, cold-chain storage and third-party logistics distribution, with 47,000 square feet of cold-chain storage available.
The expansion further includes an increase in the company’s bottle packaging capacity through the installation of 10 high-speed bottling lines for solid-based products, including tablets, capsules, caplets, softgels, and gel caps. Aphena says its future plan is to install 30 more high-speed lines in the new facility to increase monthly capacity to over 80 million bottles and becoming a partner in the pharmaceutical solid dose packaging industry.
Source: Aphena Pharma Solutions