Supplier News: WuXi STA, MilliporeSigma, Vetter & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring WuXi STA, MilliporeSigma, Vetter, Catalent, Lonza, Charles River Laboratories, Batavia Biosciences, Avantor, Eurofins, Incor, Kindeva, and CoreRx. Highlights below.
Chemicals/Chemical API Manufacturing
* WuXi STA Opens HPAPI Plant, Oligo & Peptide Mfg Facility
* Millipore Sigma Opens $65-M HPAPI Mfg. Facility
* Incor, Renovis Labs form Green Mfg JV
* MilliporeSigma, Lotte Partner for Former BMS Facility
* Charles River Labs Opens Plasmid DNA Mfg Center in UK
* Batavia Biosciences Plans Commercial Vaccine, Viral Vector Mfg Facility
* Avantor, GeminiBio Partner for Cell-Culture Media
Formulation Development/Drug Product Manufacturing
* Vetter’s Clinical Mfg Site Completes First Customer Fills
* Kindeva Drug Delivery Completes Acquisition of iPharma Labs
* CoreRx Adds Solid-Dosage Mfg Equipment
* Catalent Expands Primary Packaging for Clinical Supply
* Lonza Names Ex-Novartis Exec as Head of Group Operations
* Eurofins DiscoverX Opens Shanghai Office
Chemicals/Chemical API Manufacturing
WuXi STA Opens HPAPI Plant, Oligo & Peptide Mfg Facility
WuXiT STA, a subsidiary of WuXi AppTec, has opened a high-potency active pharmaceutical ingredient (HPAPI) plant at its site in Changzhou, Jiangsu Province, China.
The new plant consists of reactors from 250 L to 3,000 L, prep-HPLC systems, a 10-m2 tray lyophilizer, and flow-chemistry and milling technologies with capability to handle potent compounds with occupational exposure limits as low as 10 ng/m3.
WuXi STA has two sites located in Shanghai Jinshan and Changzhou, China to support the process development and manufacture of HPAPIs. In addition to HPAPIs, the Changzhou site provides process development and manufacturing for linkers, oligonucleotides, and peptides.
In addition, WuXi STA opened a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. The 30,570-square-foot oligonucleotide facility has four large-scale oligonucleotide production lines and more than 20 small- to mid-scale production lines that increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol. The new 22,260-square-foot peptide plant features three new production lines with reactors that can accommodate up to 1,000 L, increasing WuXi STA’s overall solid phase peptide synthesis total reactor volume to 6,490 L.
WuXi STA has a global network of multiple R&D and manufacturing sites across Asia, North America, and Europe, including a new pharmaceutical manufacturing campus in Middletown, Delaware that is scheduled to open in 2024.
Millipore Sigma Opens $65-M High-Potency API Mfg Facility
MilliporeSigma, the life-science business of Merck KGaA, has opened a new $65-million, 70,000-square-foot high-potency active pharmaceutical ingredient (HPAPI) manufacturing facility in Verona, Wisconsin. The new facility doubles the company’s HPAPI manufacturing capacity.
Incor, Renovis Labs form Green Mfg JV
Incor Group, a Hyderabad, India-based conglomerate, and Renovis Labs, a Hyberabad, India-based bio/pharmaceutical company, have formed a new joint venture (JV) company, Incor Renovis, focused on developing green technologies in the areas of human health, animal health, and agriculture.
The new JV will apply a directed evolution technology platform using enzymes to solve chemical process challenges, develop a microbiology platform to generate basic chemicals, and advance automation in chemical R&D and manufacturing.
Source: Incor Group
MilliporeSigma, Lotte Partner for Former BMS Facility
MilliporeSigma, the life-science business of Merck KGaA, has signed a non-binding memorandum of understanding (MoU) with the new biologics business of Lotte Group, which outlines a planned collaboration to establish Lotte’s biologics manufacturing capabilities in the US.
The MoU follows the announcement in May (May 2022) that Lotte Corporation, a Seoul, Korea-based holding company of Lotte Group with holdings in chemicals, food & beverage, retail, and hotel & service, agreed to buy Bristol Myers Squibb’s (BMS) commercial-scale biologics manufacturing facility in East Syracuse, New York. The facility will serve as the Lotte Center for North America Operations for Lotte’s new biologics CDMO business in the US. BMS and Lotte anticipated completing the transaction by the second half of 2022, subject to receipt of regulatory approvals and the satisfaction of other closing conditions.
Under the MoU with MilliporeSigma, MilliporeSigma will be a preferred supplier of Lotte to provide technical consulting, training, products, technologies, and manufacturing services.
Charles River Labs Opens Plasmid DNA Mfg Center in UK
Charles River Laboratories has opened a new 16,000-square-foot plasmid DNA Center of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, UK.
The new center follows Charles River’s acquisitions in 2021 of Cognate BioServices, a CDMO of cell and gene therapies, and Cobra Biologics, a CDMO of plasmid DNA, viral vectors, and cell therapies. The new site and the addition of three new manufacturing streams will enable the company to quadruple its plasmid DNA capacity.
Source: Charles River Laboratories
Batavia Biosciences Plans Commercial Vaccine, Viral Vector Mfg Facility
Batavia Biosciences, a Leiden, the Netherlands-based CDMO of viral vectors and vaccines, plans to extend its CDMO services portfolio, which now includes R&D and clinical manufacturing, to include commercial manufacturing. The company has finalized the design plans for a new 12,000-square-meter facility in Leiden, the Netherlands, to support late-stage clinical and commercial manufacturing of vaccines and viral vector-based gene therapies and immuno-oncology products.
The facility is expected to be operational in the third quarter of 2024. Batavia’s manufacturing technology, HIP-Vax, which uses fixed-bed bioreactors, will be the main manufacturing platform, but also traditional mammalian cell-suspension technologies up to 1,000-L scale will be applied. The facility is based on a modular design, with six production suites. Depending on the virus / vector type, the facility is expected to provide for several hundred million doses annually.
Source: Batavia Biosciences
Avantor, GeminiBio Partner for Cell-Culture Media
Avantor, a supplier of ultra-high-purity materials for the life sciences and advanced technology industries, has entered into an agreement with GeminiBio, a provider of cell-culture products and instruments, to offer custom hydrated solutions and cell-culture media for bioproduction workflow, including for emerging modalities such as gene therapies.
Formulation Development/Drug Product Manufacturing
Vetter’s Clinical Mfg Site Completes First Customer Fills
Vetter, a CDMO of aseptic filling and packaging, has completed the first customer fills at its clinical manufacturing facility in Rankweil, Austria. It reports that further batches are already planned, and more customer projects are in the business pipeline. In addition, the site is being expanded to optimize processes and increase production capabilities.
Vetter had purchased the approximately 10,000-square-meter manufacturing facility in the middle of 2020. The Rankweil site represents the company’s European counterpart to its existing clinical manufacturing site near Chicago, and increases the company’s capacity for process development as well as clinical manufacturing of Phase I and II injectables.
Kindeva Drug Delivery Completes Acquisition of iPharma Labs
Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, has completed the acquisition of iPharma Labs, a Union City, California-based inhalation contract development and research organization (CDRO).
The acquisition combines iPharma’s expertise in inhalation formulation and development of liquid, dry-powder, and propellant-based therapies with Kindeva’s expertise in developing, commercializing, and manufacturing inhaled therapies. The entire team at iPharma has joined Kindeva and will continue to operate from its existing location.
Source: Kindeva Drug Delivery
CoreRx Adds Solid-Dosage Mfg Equipment
CoreRx, a Clearwater, Florida-based CDMO of drug products, has added solid-dosage manufacturing equipment at its facilities in its Clearwater, Florida, and San Rafael, California.
The company added a Gerteis MINI-PACTOR, Gerteis MACRO-PACTOR, IMA Practica 100 Encapsulator, IMA Precisa 150 Capsule Weight Sorter, Korsch XM12 High-Speed Single/Bi-Layer Tablet Press, and a Xcelodose 600S Precision Powder Micro-Dosing System.
The company also added the following to support product development and analytical development: a Pion Rainbow 7-channel and 8-channel Dynamic Dissolution Monitor and a Logan Automated Transdermal Diffusion Cell Sampling System (Dry Heat).
CoreRx also qualified its in-house microbiology laboratory for microbial limits testing.
Catalent Expands Primary Packaging for Clinical Supply
Catalent has expanded its primary packaging capabilities at its clinical supply facility in Shiga, Japan, through the installation of a high-speed blister packaging line to complement its existing automated bottling line. The new blister packaging equipment is identical to that available across Catalent’s clinical supply services network.
The 6,000-square-meter site in Shiga opened in October 2021 to provide clinical supply-management services locally and globally,
including packaging and labeling, storage and distribution, controlled-drug and cold-chain storage and handling, as well as in-country returns and destruction services.
Lonza Names Ex-Novartis Exec as Head of Group Operations
Lonza has appointed Maria Soler Nunez, currently Chief Quality Officer at Novartis, as its new Head of Group Operations, effective August 1, 2022. She succeeds Stefan Stoffel, who has served as Head of Group Operations since January 2021 and as a member of Lonza’s Executive Committee since March 2019 and who is retiring, effective August 1, 2022.
She joins Lonza from Novartis, where she has worked since 2010 and held a succession of leadership positions in quality and operations, including Head of Global Manufacturing Functions, and Global Head of Manufacturing, Science & Technology, and most recently as Chief Quality Officer.
Eurofins DiscoverX Opens Shanghai Office
Eurofins DiscoverX, a provider of small- and large-molecule drug discovery and quality control lot release, has opened a new office in Shanghai, China.
With the new office, the company will provide its product menu cell lines, assay reagents, enzymes, and bioassay kits to the Chinese market.
Part of the contract analytical testing company, Eurofins, Eurofins DiscoverX Eurofins provides cell lines, membrane preps, enzymes, and reagents for drug discovery and development from three R&D manufacturing Centers of Excellence: San Francisco Bay Area, California; St. Louis, Missouri, and Poitiers, France.