Catalent Completes Biomfg Expansions; Aceto Acquires A&C
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Lonza, Aceto, Abzena, and Ascendia Pharmaceuticals.
Chemicals/Chemical API Manufacturing
Aceto Acquires A&C
Aceto, a provider of specialty materials for life sciences and advanced technology end markets, has acquired A&C, a GMP manufacturer of specialty excipients, buffers, and process solutions. The company provides GMP custom ingredient development, manufacturing, and packaging. Aceto will continue to support A&C’s manufacturing facilities and offices in the US, Canada, and Ireland.
Catalent Completes Biomanufacturing Expansions
Catalent has completed the expansion of two new suites at its biologics drug-substance development and manufacturing facility in Madison, Wisconsin. The expansion increased the number of manufacturing suites at the site to five to more than double its overall cGMP-scale capacity.
Each new suite includes a 2 × 2,000-liter single-use bioreactor system capable of processing batches of 2,000 liters or 4,000 liters for cGMP clinical and commercial manufacturing. The first engineering batch in the new suite began in March (March 2021), with the first cGMP batch expected to be manufactured during May (May 2021). The second new suite is being prepared to begin its first engineering batch in May (May 2021), ahead of its first cGMP batch in mid-July (July 2021).
The addition of the two new manufacturing suites adds to an existing 2 × 2,000-liter suite, a 1,000-liter suite, and a 500-liter suite. Catalent Biologics’ drug-substance manufacturing network also includes a facility in Bloomington, Indiana, which houses two 2,500-liter stainless-steel bioreactors, a 1,000-liter single-use bioreactor, and drug-product fill-finish and packaging capabilities.
Lonza Expands Endotoxin Testing Service
Lonza has expanded its PyroTec PRO Automated Robotic Solution for endotoxin testing to bring a third test type option to its platform. The new PyroWave Reader add-on has been designed for use with the PyroGene Recombinant Factor C (rFC) Assay.
Abzena Selects North Carolina for New Biomanufacturing Facility
Abzena, a contract manufacturer of biologics and antibody drug conjugates, has selected Sanford, North Carolina as the location of its new $200-million biologics manufacturing facility in the US.
Sanford will be Abzena’s sixth site in its global network and will be dedicated to cGMP manufacturing capacity for mammalian biologics.
The design of the facility has been optimized for Phase III and commercial manufacturing of biologics. A phased approach to construction will initially allow four modular suites. Each suite will include up to two 2,000-L bioreactors. The initial phase will be followed by the addition of two further 2,000-L suites. Additionally, the site will be equipped to handle existing and new advances in manufacturing such as continuous manufacturing and perfusion. GMP manufacturing will commence in mid-2022.
Formulation Development/Drug Product Manufacturing
Ascendia Pharmaceuticals Gains Funding for Facility Expansion
Ascendia Pharmaceuticals, a North Brunswick, New Jersey-based CDMO of drug products, has received an investment by Signet Healthcare Partners, a New York-based private-equity firm, to fund Ascendia’s facility expansion.
Founded in 2012, Ascendia provides pre-formulation, formulation development, manufacturing, and stability services for parenteral, oral, and topical dosage forms.
Source: Ascendia Pharmaceuticals
Catalent Adds Cryogenic Capabilities for Cell and Gene Therapies
Catalent has added cryogenic capabilities at its clinical supply services facility in Philadelphia, Pennsylvania to support sponsors developing cell and gene therapies.
Part of the facility has been dedicated for the handling of cell- and gene-therapy samples, which includes cryogenic storage to allow biological materials to be preserved in liquid nitrogen vapor at temperatures of -180 °C. The facility also has the ability to package, label, and distribute cryogenic materials for clinical trials. It has been designed so that capacity can be expanded for clinical and commercial use.
The 200,000 square-foot facility is the largest site in Catalent’s global clinical supply network, which includes sites in the US, the UK, Germany, Singapore, Japan and China, and an extended network of over 50 depots,