Supplier News: Helsinn, Samsung, Piramal & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring HAS Healthcare Advanced Synthesis, Lonza, Samsung Biologics, Emergent BioSolutions, Catalent, Piramal Pharma Solutions, Eurofins CDMO, Procaps, Ori Biotech, and Forge Biologics.
Chemicals/Chemical API Manufacturing
Helsinn Advanced Synthesis SA Rebrands, Launches as Independent Company
HAS Healthcare Advanced Synthesis SA, formerly Helsinn Advanced Synthesis SA and part of the Helsinn Group, has launched as an independent, privately held company.
Originally established as part of the Helsinn Group by the Braglia family, under the name Helsinn Advanced Synthesis SA, the company has been a CDMO since 1984. The company is a CDMO of active pharmaceutical ingredients (including high-potency APIs) and advanced intermediates with manufacturing operations in Biasca, Switzerland.
HAS Healthcare Advanced Synthesis SA will operate as a subsidiary of the newly formed 3B Future Holding SA (also wholly owned by the Braglia family). The company’s executive team will remain in place, and Waldo Mossi, previously General Manager, has been appointed as Chief Executive Officer of HAS Healthcare Advanced Synthesis. Mossi has been with the company for 27 years and as General Manager for the past eight years.
Going forward, HAS Healthcare Advanced Synthesis says it intends to build new laboratories to further strengthen its pharmaceutical offering.
Samsung Biologics To Build Vaccines, Cell/Gene Therapy Mfg Facility
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has announced plans to start construction of a new manufacturing facility for multi-modal products, including cell and gene therapies and vaccines using messenger RNA (mRNA), plasmid DNA (pDNA), and viral vectors, all at a single site.
This facility will be in addition to the mRNA vaccine drug-substance manufacturing suite the company is currently adding to its existing facility in Songdo, South Korea, which is expected to be ready for operations within the earlier part of this year (2022).
The company says it is also venturing into securing additional sites within Songdo for the construction of a sixth manufacturing facility and innovation center, and also overseas in multiple locations to maximize its manufacturing capacity to produce large-scale biologics.
Samsung Biologics’ fourth biopharmaceutical manufacturing plant is currently under construction and is scheduled to be partially operational by the end of this year (2022). Upon its full completion in 2023, the company will have a total of 620,000 L of capacity.
Source: Samsung Biologics
Emergent BioSolutions Founder/Executive Chairman To Retire
Fuad El-Hibri, the Founder and Executive Chairman of Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, has decided to retire, effective April 1, 2022.
He served as Chief Executive Officer for almost 14 years until March 2012 and as Executive Chairman for 10 years.
Source: Emergent BioSolutions
Lonza Launches Technology for Discovery of Bispecific Antibodies
Lonza has launched a new technology platform for the discovery and design of bispecific antibodies (bsAbs).
Lonza’s bYlok technology was developed to design, develop, and manufacture bsAbs molecules at scale. The bYlok technology relies on adjustments of the position of one of the disulfide bridges, which greatly favors the formation of a correct heterodimer species. Access to the bYlok technology is available under a research license to pharma and biotech companies globally.
Ori Biotech Raises $100 M for Cell-,Gene-Therapy Mfg Platform
Ori Biotech, a London-based cell- and gene-therapy manufacturing technology company, has secured over $100 million in funding to expand its cell- and gene-therapy manufacturing platform.
Ori will use the funds to expand personnel across all functions in order to transition through pre-commercialization to the launch of its cell- and gene-therapy manufacturing platform. The company is also launching a platform allowing select partners to gain pre-launch access to the Ori platform in 2022. The Ori platform is a manufacturing system that closes, automates, digitizes, and standardizes cell- and gene-therapy manufacturing.
Source: Ori Biotech
Gene-Therapy CDMO Forge Biologics Gets $80 M For Expansion
Forge Biologics, a Grove City, Ohio-based gene therapy-focused CDMO, has secured $80 million for its manufacturing expansion plans.
The expansion will coincide with an accelerated expansion of Forge’s adeno associated virus viral-vector manufacturing facility in Columbus, Ohio. Forge entered into a secured financing agreement with MidCap Financial that provides up to $80 million of borrowing capacity.
Forge initiated the facility expansion in 2021 and is increasing the overall manufacturing footprint of the company to over 200,000 square feet of facility space, including 20 manufacturing suites, with the ability to add more suites in the current facility in the future (as reported on January 10, 2022).
Source: Forge Biologics
Formulation Development/Drug-Product Manufacturing
Catalent Launches Service for Development of Oral Drugs
Catalent has launched of a new service designed to accelerate the development of oral drugs through Phase I clinical studies.
The Xpress Pharmaceutics service will be delivered by formulation development teams at Catalent’s facilities in Nottingham, UK, and Beinheim, France, and is supported by the company’s global Regulatory Affairs team.
Piramal Adds Scale Roller Compactor at Pennsylvania Site
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients and drug products, has added development/commercial-scale roller compaction technology at its Sellersville, Pennsylvania drug-product facility. The equipmentis designed to handle both development and commercial-scale roller compaction and enhances the site’s dry granulation and scale-up services.
Source: Piramal Pharma Solutions
Eurofins CDMO Expands Spray-Drying Capacity
Eurofins CDMO has expanded its existing spray-drying development and production services in North America. The Mississauga, Ontario, Canada facility has expanded its spray-drying capabilities with the addition of a GEA Mobile Minor spray-drying system and dedicated 500-square-foot cleanroom.
Procaps Group Acquires Softgel Mfg Facility
Procaps Group has acquired an 86,000-square-foot pharmaceutical production facility from Strides Pharma, a Bengaluru, India-headquartered pharmaceutical company and contract manufacturer.
The facility, located in West Palm Beach, Florida, offers development and analytical testing capacities. Core assets included in the acquisition were several softgel encapsulation lines, new critical support systems, automated packaging line capabilities, as well as development facilities, including pilot and scale-up capabilities. Procaps Group expects the facility to begin operations in May of 2022.
Source: Procaps Group