Supplier News: Wacker, Cambrex, Experic & More
The latest from CDMOs, CMOs, and suppliers featuring Wacker, Cambrex, AGC Biologics, Experic, NewBiologix, Ascend, SynCrest, and Avirmax CMC.
Chemicals/Chemical API Manufacturing
* Wacker Completes $109-M Acquisition of ADL BioPharma
* Cambrex Adds Process R&D Suites, Kilo Lab to Flow-Chemistry Specialist Snapdragon Chemistry
* Otsuka’s, Yokogawa Electric’s JV SynCrest Launches as a CDMO
Biologics Manufacturing
* AGC Biologics Launch Two New Viral Vector Platforms
* NewBiologix Launches as Cell- & Gene- Therapy CDMO
* Ascend Launches as Cell- & Gene-Therapy CDMO
* Avirmax CMC Opens Clinical Viral Vector Mfg Facility
Formulation Development/Drug Product Manufacturing
* Experic Adds Spray-Drying to New Jersey Site
Chemicals/Chemical API Manufacturing
Wacker Completes $109-M Acquisition of ADL BioPharma
Wacker, a chemicals company, has completed its acquisition of ADL BioPharma, a León, Spain-based CMO, for more than EUR 100 million ($109 million).
In 2016, Wacker acquired ADL BioPharma’s production assets in León, with a fermentation capacity of 800 cubic meters and has since produced fermentation-based cystine on a contract basis. Following this acquisition, Wacker upgraded the existing facilities and invested in additional production equipment. The company also created some 60 new jobs at the site, quadrupling the number of employees. The acquisition of ADL BioPharma now makes Wacker the owner of the entire plant, with total fermentation capacities of just under 3,000 cubic meters.
Source: Wacker
Cambrex Adds Process R&D Suites, Kilo Lab to Flow-Chemistry Specialist Snapdragon Chemistry
Cambrex has completed the second phase of a 51,000 square-foot expansion at Snapdragon Chemistry, a Waltham, Massachusetts-based provider of flow-chemistry process design and technology development services. Cambrex acquired Snapdragon Chemistry in January (January 2023).
The expansion adds an additional 12,000 square feet to Snapdragon’s active pharmaceutical ingredient (API) development and manufacturing facility, including new process research and development suites with 24 hoods, a GMP stability suite, and a fifth GMP kilo-lab, designed for multi-step, end-to-end continuous processing. The new labs feature 100-L and 60-L glass-lined steel reactors, a 10-L plug flow reactor, tangential flow filtration and a nanofiltration skid, a 5-kW photoreactor, and a GMP-qualified LabOS supervisory control and data acquisition system. The new suites will be operational in June 2023.
Snapdragon’s new capabilities align with Cambrex’s ongoing investments in continuous flow process development and small-scale clinical and commercial manufacturing at Cambrex’s facility in High Point, North Carolina.
Source: Cambrex
Otsuka’s, Yokogawa Electric’s JV SynCrest Launches as a CDMO
SynCrest, a joint venture of Otsuka Chemical and Yokogawa Electric, a Tokyo-based provider of advanced technologies and products for measurement, control, and information support, has launched contract research, development, and manufacturing (CRDMO) services for peptides and nucleotides in Japan, Europe, North America, and South America. SynCrest was formed earlier this year (March 2023).
Using advanced continuous flow synthesis with in-line measurement, the company produces active pharmaceutical ingredients (APIs), intermediates, and raw materials. SynCrest provides a service for peptide-based therapeutics, from library synthesis and process development to clinical and commercial manufacturing.
Manufacturing of the APIs, intermediates and raw materials is carried out at SynCrest’s plant in Naruto, Tokushima Prefecture, Japan.
Source: SynCrest
Biologics Manufacturing
AGC Biologics Launch Two New Viral Vector Platforms
AGC Biologics, a CDMO of protein-based therapeutics and advanced therapies, has launched two new viral vector platforms: BravoAAV, for adeno-associated viral vector (AAV) development and ProntoLVV, for lentiviral vector (LVV) development.
The BravoAAV and ProntoLVV platforms have production at different scales in suspension up to 2,000 L and adhesion up to 750 L and include prequalified scale-down models. The AGC Biologics AAV and LVV platforms include in-network plasmid DNA (pDNA) supplies, in-house testing, cell factories and fixed-bed bioreactors for adherent protocols, and wave and stirrer bioreactors for suspension.
Source: AGC Biologics
NewBiologix Launches as Cell- & Gene- Therapy CDMO
NewBiologix has launched as a cell- and gene-therapy CDMO based in Lausanne, Switzerland. The company recently raised $50 million with funding led by Recipharm, a CDMO of small-molecule active pharmaceutical ingredients, biologics, and drug products and the company’s co-founders, Igor Fish, the company’s CEO, and Nicolas Mermod, the company’s Senior Vice President, Research & Development,
The company’s DNA-based platform is being developed to address manufacturing challenges associated with the production of recombinant adeno-associated virus (rAAV) vectors. Specifically, the company’s technologies will be applied to human (HEK-293) and mammalian (CHO) cell lines. The company will begin beta testing the cell-line prototypes with key collaborators by 2024 and anticipates making viral production cell lines commercially available by 2026.
Source: NewBiologix
Ascend Launches as Cell- & Gene-Therapy CDMO
Ascend Gene & Cell Therapies has launched as a cell- and gene-therapy CDMO. The company provides process development, clinical manufacturing, and analytical and regulatory support. Originally founded by Monograph Capital, an investment firm, Ascend has raised a total of $132.5 million.
The company is focused on adeno-associated virus vectors. Its operations are headquartered in the UK with GMP production in Potters Bar, North London, platform technology research in the San Francisco Bay Area, California, and a specialist process development and analytics team in Munich, Germany.
Source: Ascend
Avirmax CMC Opens Clinical Viral Vector Mfg Facility
Avirmax CMC, a spin-off CDMO of Avirmax, a Hayward, California-based gene-therapy company, has opened a 20,000-square foot, clinical-scale GMP, adeno-associated virus vector (AAV) manufacturing facility in Hayward.
The facility contains cGMP suites, developmental and testing laboratories and is equipped with single-use bioreactors at 50-L, 200-L, and 1,000-L production scales, which can deliver recombinant AAV drug product at 1016-18 vector genome per batch within approximately 200 days starting from a transgene DNA plasmid.
Source: Avirmax CMC
Formulation Development/Drug Product Manufacturing
Experic Adds Additional Spray-Drying Capabilities
Experic, a Cranbury, New Jersey-based CDMO of drug products, has added spray-drying capabilities at its facility in Cranbury, New Jersey, through the addition of a new pilot-scale spray dryer to handle powder formulations for both oral solid dose and products for delivery to the lungs. The new pilot-scale spray dryer is expected to be available in July 2023 upon completion of installation and validation activities.
Source: Experic
