Supplier News: Novasep, Asymchem, Catalent, & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Novasep, PharmaZell, Sterling Pharma, Asymchem, Catalent, Fujifilm, Merck KGaA, CHA Medical & Bio Group, Abzena, OmniaBio, Symbiosis Pharmaceutical Services, INCOG Biopharma, Croda, Alcami, and Charles River Laboratories.
Chemicals/Chemical API Manufacturing
Novasep, PharmaZell Merge To Create New CDMO
Novasep, a Lyon, France-based CDMO of active pharmaceutical ingredients (APIs) and antibody drug conjugates, and PharmaZell, a Raubling, Germany-based CDMO of small-molecule APIs, have closed a merger of the companies. The companies had entered exclusive negotiations initiated in September 2021, to create a CDMO and API manufacturer.
The combined company has a footprint in Europe, the US, and India with combined revenues of nearly EUR 500 million ($545 million) and more than 2,000 employees across 10 production and R&D sites: seven in Europe, two in India, and one in the US.
Sterling Pharma Investing $1.3 M To Expand Bioconjugation, ADC Labs
Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, is investing £1 million ($1.3 million) in an expansion project at its bioconjugation and antibody-drug conjugates (ADCs) facility in Deeside, UK site.
The project will increase the current laboratory space from 275 to 419 square meters and reconfigure the layout to provide the ability to develop and expand areas in the future.
This investment supports the growth of the company’s ADC capabilities since it acquired the 6,500 square-meter site in April 2021, expands the facility’s scientific and analytical teams and establishes cGMP bioconjugation/ADC manufacturing capabilities. The work and expansion will allow for the recruitment of up to five additional scientists. The company is currently integrating the site’s quality management systems in line with its global practices and is now commissioning the quality control and manufacturing facilities in readiness for GMP certification, which the company anticipates will be in place by late 2022.
Sterling’s Deeside facility was part of its acquisition of ADC Biotechnology. Sterling recently announced investment at two further facilities in its global network: a £1.5-million ($1.95- million) expansion project its early-phase development site in Cary, North Carolina; and a planned £10-million ($13-million) investment in process development and commercial-scale manufacturing capacity at its headquarters in Dudley, UK. Additionally, in March 2022, Sterling announced a deal to acquire Novartis’ 110-acre Ringaskiddy API manufacturing campus, with the deal likely to close by the end of 2022.
Source: Sterling Pharma Solutions
Asymchem Advances API Expansions in China
Asymchem, a Tianjin, China-headquartered CDMO, has accelerated the construction of several small-molecule R&D and production sites across China. By the end of 2022, it plans to have added 1,700 m³ of small-molecule batch capacity in Dunhua, Tianjin, and Yangtze River Delta, doubling existing batch capacity.
The company has completed construction of a new building at its Dunhua, China, production site. The expansion will add nearly 500 m³ of batch capacity for upcoming commercialization projects. In addition, an active pharmaceutical ingredient (API) building expansion was completed at the company’s Tianjin site, with an expected new batch capacity of 160 m³.
Additionally, Asymchem says it plans to continue to increase the application of continuous flow technology at all of its sites. This includes upgrading several current modules and buildings and adding continuous-flow equipment in new facilities.
Catalent Investing $160 M for a New Biologics Mfg Facility
Catalent has acquired a biologics development and manufacturing facility near Oxford, UKfrom Vaccine Manufacturing and Innovation Centre UK Limited, a not-for-profit organization established to provide the UK government with vaccine development and manufacturing capability.
Catalent plans to invest up to $160 million to complete the building of the facility and equip it with capabilities for the development and manufacture of biologic therapies and vaccines, including mRNA, proteins, and other advanced modalities. It is expected that the new facility will employ more than 400 people and support public and private organizations seeking to develop and manufacture biotherapeutics.
Fujifilm Acquires Cell-Therapy Mfg Facility from Atara Biotherapeutics
Fujifilm has completed the acquisition of a dedicated cell-therapy manufacturing facility from Atara Biotherapeutics, a South San Francisco, California-based bio/pharmaceutical company, for $100 million. The company had announced the acquisition in January (January 2022).
The facility, located in Thousand Oaks, California, will be operated by Fujifilm Diosynth Biotechnologies a CDMO and subsidiary of Fujifilm Corporation.
As part of a long-term manufacturing and services agreement, Fujifilm Diosynth Biotechnologies will support the production of Atara’s clinical and commercial-stage allogeneic cell therapies at the site, including tabelecleucel, currently in Phase III clinical development and under review to support registration in Europe, for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease.
Merck KGaA To Acquire Bioreactor Sampling Platform from Lonza
Merck KGaA has announced plans to acquire the Modular Automated Sampling Technology (MAST) platform from Lonza, an automated aseptic bioreactor sampling system.
The MAST platform enables the gathering of more frequent samples and collection of real-time data, including product attributes, compared to manual sampling. One MAST system unit can collect samples from up to 10 bioreactors and connect them to four primary analyzers.
Upon closing the deal, the MAST platform will be part of the BioContinuum Platform of Merck KGaA’s life sciences business, MilliporeSigma.
Source: Merck KGaA
CHA Medical Investing $250 M for Cell-, Gene Therapy Mfg and Stem-Cell Banking
CHA Medical & Bio Group, a Pangyo, South Korea-based healthcare enterprise, has begun construction of a facility in Pangyo, South Korea, for cell and gene therapy manufacturing facility and stem-cell biobanking.
With an investment of more than $250 million, construction of the new 710,000-ft2 site is expected to be completed by the end of 2024. The space dedicated for cell and gene therapy will offer integrated CDMO services for mRNA, viral vectors, and plasmid DNA, and GMP production.
Source: CHA Medical & Bio Group
Canadian-Based OmniaBio Launches as CDMO
OmniaBio, a subsidiary of CCRM, a global, public–private partnership headquartered in Canada, has launched as a CDMO.
Subject to final agreement, OmniaBio will be the recipient of a loan of up to $40 million from the government of Ontario, Canada, which will kickstart the construction of a 250,000-ft2 facility for cell and gene therapies.
The facility, part of a biomanufacturing center of excellence being built in Hamilton, Ontario, will use CCRM’s existing capabilities by providing Phase III and commercial-scale manufacturing of gene-modified cell therapies and viral vectors.
Abzena Opens New Biologics Testing Laboratory
Abzena, a CDMO of biologics and antibody drug conjugates, has opened of a new biologics testing laboratory in close proximity to the company’s biologics process development and manufacturing hub in San Diego, California. The facility gives Abzena’s partners access to cell-based and PCR safety assays and viral clearance studies to support their regulatory filings.
With this latest investment, the company now offers both traditional and rapid molecular detection methods, with all services appropriate for research cell banks, characterization of master and working cell banks, end-of-production of cell cultures, and bulk drug substances.
Late last month (March 2022), the company announced a new round for an additional $65 million from majority-owner Welsh, Carson, Anderson & Stowe (WCAS), Biospring Partners, and other affiliated investors. Abzena is opening a new GMP manufacturing facility in Sanford, North Carolina, expected in the fourth quarter this year (2022), its sixth site in its global network.
Formulation Development/Drug-Product Manufacturing
Croda Gets UK Gov’t Grant To Expand Specialty Lipid Mfg
Croda International, a producer of oleochemicals, excipients, and other ingredients, has been awarded a £15.9-million ($20.7-million) grant by the UK government to expand its manufacturing facility in Leek, Staffordshire, UK, for specialty lipids. Croda will also invest £15.9-million ($20.7-million) in the expansion.
The expansion will include building a lipid system synthesis facility and enhancing analytical laboratory capabilities at Leek. The site specializes in the production of lipids, which are currently used in a number of COVID-19 mRNA vaccines, as well as other Croda healthcare technologies such as speciality excipients. The investment will expand the range of specialty lipids produced at the site and add additional production capacity.
From 2023, the UK government says the expanded facility will be able to produce a sufficient volume of lipids for around 3 billion vaccine doses, an estimate based on the volume of lipids required to produce existing COVID-19 vaccines.
Symbiosis Completes $1.7-M UK Gov’t Funded Project
Symbiosis Pharmaceutical Services, a Stirling, Scotland-based CMO specializing in sterile manufacturing has completed a £1.3-million ($1.7-million) collaborative UK government-funded project as part of a medicines manufacturing challenge.
Symbiosis and The Cell and Gene Therapy Catapult (CGT Catapult), a center of excellence funded by Innovate UK, the UK government’s innovation agency, have successfully completed a partnership with Freeline Therapeutics, a Stevenage, UK-based gene-therapy company, for the sterile filling and manufacturing process of a drug product. The collaboration established a streamlined manufacturing process with an advanced testing package and also established an improved contamination control process.
INCOG Biopharma Completes Construction of Cleanroom Area
INCOG BioPharma Services, a CDMO of sterile injectables, has completed the construction of cleanroom production area within the company’s new 90,000-ft2 manufacturing site. The project is part of an overall $100-million investment for the new facility.
The newly completed cleanroom area will feature a multi-use aseptic filling line, including fully integrated isolator technology that can process both bulk vials and ready-to-use vials, syringes, and cartridges. The company plans to be cGMP ready by the third quarter of 2022. In addition, INCOG plans to conduct formulation activities, inspection, labeling, and packaging services in its recently constructed manufacturing space.
The company has hired nearly 50 people in the last several months (as reported on April 5, 2022) and plans to add another 50 positions by the end of 2023.
Source: INCOG Biopharma
Alcami Expanding Bio-Storage
Alcami, a CDMO of drug products and provider of analytical testing services, has announced plans to expand its bio-storage footprint at Masy BioServices, which the company acquired in December 2021.
A new 160,000-square-foot facility, purpose-built for cGMP pallet storage space at 15°C to 30°C, will join the company’s existing New England campus. Located in Amherst, New Hampshire, the facility will come on line in three phases, with the first phase on line in April 2022, with immediate capacity for over 7,000 pallets. Phase Two is targeted to come on line in the second half of 2022, which will double capacity. Masy BioServices now operates four cGMP biostorage facilities near Boston.
Charles River Acquires Explora BioLabs for $295 M
Charles River Laboratories, a Wilmington, Massachusetts-headquartered contract research organization, has acquired Explora BioLabs Holdings, a San Diego, California-based provider of contract vivarium research services, for $295 million.
Explora BioLabs offers contract vivarium operation services, providing in-vivo vivarium facilities, management, and related services for conducting early-stage research activities. Explora BioLabs currently operates more than 15 preclinical vivarium facilities, offering rental space in biohubs in Southern California, San Francisco, Boston, and Cambridge, Massachusetts, with a planned expansion in Seattle in 2022. With over 100 employees, it also offers contract vivarium management, staffing, and regulatory services to manage research sites.
Explora BioLabs has become part of Charles River’s Research Models and Services segment.
Source: Charles River Laboratories