Supplier News: Samsung, Evonik, WuXi Biologics & More
The latest from CDMOs, CMOs, and suppliers featuring Samsung Biologics, Evonik, WuXi Biologics, Thermo Fisher Scientific, Syngene, CoJourney, Upperton Pharma Solutions, GenScript, NorthX Biologics, and MilliporeSigma.
Chemicals/Chemical API Manufacturing
* Evonik, Heraeus Partner To Expand HPAPI Capabilities
Biologics Manufacturing
* Samsung Biologics, Novartis in $403-M Biomanufacturing Pact
* WuXi Biologics Plans Spin-off of Bioconjugation Unit
* Syngene To Acquire Biomanufacturing Facility in India from Stelis Biopharma
* CoJourney Raises $30 M; Expands Cell- and Gene-Therapy Mfg Capacity
* GenScript Expands Mfg Capacity for sgRNA and Non-viral DNA Payloads
* CDMO NorthX Biologics Acquires Clinical Biomanufacturing Facility from Valneva
* MilliporeSigma Investing $25 M To Expand Cell-Culture Media Mfg Facility
Formulation Development/Drug Product Manufacturing
* Upperton Completes Build-Out of New $20-M Mfg Facility
General
* Thermo Fisher To Acquire CoreEvitas for $913 M
Chemicals/Chemical API Manufacturing
Evonik, Heraeus Partner To Expand HPAPI Capabilities
Evonik, a manufacturer of excipients, active pharmaceutical ingredients (APIs), fine chemicals, and specialty chemicals, and the Pharmaceutical Ingredients business of Heraeus Precious Metals, a refiner of platinum group metals and products and trader of industrial precious metals, are collaborating to expand both companies’ range of services for highly potent active pharmaceutical ingredients (HPAPIs).
Source: Evonik
Biologics Manufacturing
Samsung Biologics, Novartis in $403-M Biomanufacturing Pact
Samsung Biologics, a CDMO of biologics, has formed a contract with Novartis for the manufacture of biologics for KRW 511 billion ($403 million).
The contract is a five-year contract, with the deal ending at the end of 2028. The contract period is subject to change in accordance with contract terms, such as the adjustment of the manufacturing schedule. Samsung Biologics did not disclose what is specifically being manufactured for Novartis.
Samsung Biologics recently also signed multi-million dollar biomanufacturing pacts with Pfizer.
Source: Samsung Biologics
WuXi Biologics Plans Spin-off of Bioconjugation Unit
WuXi Biologics, a CDMO of biologics, has announced the proposed spin-off and separate listing of its subsidiary, WuXi XDC, on the Hong Kong Stock Exchange. WuXi XDC is a joint venture between WuXi Biologics and WuXi STA (a subsidiary of WuXi AppTec) and provides contract research, development and manufacturing services for bioconjugates, including antibody drug conjugates. Its services cover antibodies and other biologics intermediates, chemical payloads and linkers as well as bioconjugated drug substances and drug products. WuXi XDC will remain as a consolidated subsidiary upon the completion of the proposed listing.
Source: WuXi Biologics
Syngene To Acquire Biomanufacturing Facility in India from Stelis Biopharma
Syngene, a Bangalore, India-based CDMO of small-molecule active pharmaceutical ingredients and biologics, has agreed to acquire a manufacturing facility in Bangalore for INR 702 crores ($86 million) from Stelis Biopharma, a Bangalore, India-based CDMO of biologics.
On completion of the transaction, the site will add 20,000 liters of installed biologics drug-substance manufacturing capacity for Syngene. The site has the potential for future expansion up to a further 20,000 liters of biologics drug-substance manufacturing capacity. It also includes a commercial scale fill–finish unit. The facility, which was initially built to manufacture Covid 19 vaccines, is now being repurposed to manufacture monoclonal antibodies. Syngene says it will further invest up to INR 100 crores ($12 million) to repurpose and revalidate the facility.
Syngene will acquire the facility on a slump sale basis for a gross value of INR 702 crores ($86 million). Subject to closing adjustments, the consideration for the transaction will be settled in cash. The transaction has been approved independently by the respective Boards of Directors of both companies. The transaction is expected to close within 90 days (as reported on July 4, 2023), subject to customary conditions, including receiving the required lender and regulatory approvals.
Source: Syngene
CoJourney Raises $30 M; Expands Cell- and Gene-Therapy Mfg Capacity
CoJourney, a Gwynedd, Pennsylvania-based CDMO of cell- and gene-therapies, has raised $30 million in financing to support expansion of its US organization and commercial manufacturing capabilities. CoJourney has developed processes to support end-to-end development and manufacturing for genetic medicines, including plasmids, viral vectors, and mRNA. The company has built 130,000-square-foot cGMP manufacturing facilities that include 500-L and 2,000-L disposable bioreactors for viral vectors and 30-L disposable fermenters for plasmids.
Source: CoJourney
GenScript Expands Mfg Capacity for sgRNA and Non-viral DNA Payloads
GenScript Biotech, a Piscataway, New Jersey-based CDMO of biologics and related products and services, has expanded its cGMP manufacturing capacity for sgRNA and non-viral DNA payloads with a new 400,000-square-foot facility in Zhenjiang, Jiangsu Province, China.
Source: GenScript Biotech
CDMO NorthX Biologics Acquires Clinical Biomanufacturing Facility from Valneva
NorthX Biologics, a Matfors, Sweden-based CDMO of biologics, has acquired a clinical-trial manufacturing unit in Stockholm, Sweden, from Valneva, a vaccines company.
The acquisition includes the transfer of a multi-purpose facility, situated in the Stockholm life science cluster. In addition, 30 staff members who currently operate the facility will also join NorthX. The acquired unit has process development, scale-up, GMP production, quality control analytics, and quality assurance/release capabilities and can work with Biosafety Level (BSL) 2/2+ and BSL 3 organisms.
Source: NorthX Biologics
MilliporeSigma Investing $25 M To Expand Cell Culture Media Facility
MilliporeSigma, the life science business of Merck KGaA, has announced an investment of $25 million to expand its facility in Lenexa, Kansas, to add 98,000 square feet of lab space and production capability to manufacture cell-culture media.
Source: MilliporeSigma
Formulation Development/Drug Product Manufacturing
Upperton Completes Build-Out of New $20-M Mfg Facility
Upperton Pharma Solutions, a Nottingham, UK-based CDMO of drug products, has completed the build of its new £15-million ($20 million) development and GMP manufacturing headquarters in Nottingham, UK.
The new 50,000-square-foot site provides Upperton with a manufacturing footprint increase from 1,300 square feet to 13,000 square feet and an expansion of analytical laboratory space from 880 square feet to 8,500 square feet. The facility has the capability to handle highly potent and controlled drugs in a range of dosage forms and supports early formulation development and clinical trial supplies from Phase I to Phase III. The facility includes investments in commercial-scale equipment by offering powder blending up to 250 kg per batch, capsule filling up to 40,000 capsules/hour, dry-granulation processing up to 100 kg/hour, and tablet pressing up to 120,000 tablets/hour.
Upperton will now begin the commissioning of the facility, along with the installation and validation of the new equipment. The company says its goal is to become fully operational by the fourth quarter of 2023 for development and non-GMP manufacturing, with a view to starting GMP operations in January 2024.
Source: Upperton Pharma Solutions
General
Thermo Fisher To Acquire CoreEvitas for $913 M
Thermo Fisher Scientific has agreed to acquire CorEvitas, a Waltham, Massachusetts-based provider of clinical services and regulatory support for drug development, for $912.5 million.
CorEvitas manages 12 registries, including nine autoimmune and inflammatory syndicated registries. Its multi-therapeutic data intelligence platform builds and scales multiple clinical registries across specific therapeutic areas to gather patient clinical data spanning more than 400 investigator sites and over 100,000 patients followed longitudinally.
The transaction is expected to be completed by the end of 2023, and is subject to customary closing conditions, including regulatory approvals. Upon completion, CorEvitas will become part of Thermo Fisher’s Laboratory Products and Biopharma Services segment.
Source: Thermo Fisher Scientific
