Supplier News: Flamma, Catalent, Fujifilm & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Flamma, Seqens, Fujifilm Irvine Scientific, Societal CDMO (formerly, Recro Pharma) Catalent, ten23 health, Stevanato Group, Thermo Fisher Scientific, Rentschler Biopharma, and Vetter.
Chemicals/Chemical API Manufacturing
Flamma To Acquire API Mfg Site from Teva
Flamma Group, a CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has announced that it will acquire a third API manufacturing site in Italy as of April 2022.
Flamma reached an agreement earlier this year (2022) with Teva Group for acquiring the Sicor Bulciago site located in Lecco, Italy, 30 kilometers from Flamma’s headquarters. The GMP facility has more than 600 cubic meters of manufacturing capacity and has been previously inspected by the FDA, the Italian Ministry of Health (AIFA), the Brazilian Health Regulatory Agency (ANVISA) and has been accredited by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
With the Bulciago site, Flamma adds 600 cubic meters of manufacturing capacity to bring its total capacity in Italy to over 900 cubic meters. This goes along with the soon-to-be 600 cubic meters of manufacturing capacity in China as the company begins expansion of Flamma Honkai this year (2022).
This is the latest in a series of investments for the company, which over the past several years has included the addition of Flamma USA in Malvern, Pennsylvania, just outside Philadelphia, to handle early-stage small-molecule projects. The soon-to-be completed R&D expansion at the company’s site in Chignolo, Italy, will quadruple its R&D space there and allow for more R&D capabilities and additional analytical resources. Flamma says it will invest over EUR 150 million ($167 million) over the next three years for increasing capacity and adding new technologies across its sites in Italy, China, and the US.
Source: Flamma Group
Seqens Invests in R&D Labs
Seqens has announced a multi-million-dollar investment in its research and development laboratory in Devens, Massachusetts.
The company says the improvements will increase Seqens’ R&D capability and productivity in and enhance its capabilities in the development and production of active pharmaceutical ingredients (APIs) and active delivery systems (lipids and polymers) development. Completion of the project is expected beginning 2023.
The investment comes three months after SK Capital became a majority holder in Seqens by merging it with SK Capital’s portfolio company, Wavelength Pharmaceuticals, a Petah Tikvah, Israel-based CDMO of APIs.
The addition of Wavelength broadens Seqens’ global reach by providing production facilities in Israel and India and sales offices in Europe and the US. It also broadens Seqens’ API portfolio and its cytotoxic, steroidal, and high-potency products. Wavelength’s expertise in complex pharmaceutical synthesis is complementary to Seqens’ core competencies. In total, the expanded portfolio now includes 200 APIs, 500 pharmaceutical intermediates, and key specialty ingredients and chemicals.
Fujifilm Irvine Scientific Acquires Shenandoah Biotechnology
Fujifilm Irvine Scientific, a supplier of cell-culture media for life-science research, bioproduction, and cell-therapy manufacturing has acquired Shenandoah Biotechnology, a Warminster, Pennsylvania-based company that manufactures recombinant proteins, including cytokines and growth factors.
Formulation Development/Drug Product Manufacturing
Recro Pharma Renamed Societal CDMO
Recro Pharma, a CDMO of drug products based in Gainesville, Georgia, is changing its name to Societal CDMO, Inc. to reflect the corporate transformation that has taken place primarily as a result of its 2021 acquisition and integration into the company of Irisys, a San Diego, California-based CDMO of various dosage forms, including oral liquids, sterile injectables, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles.
Since the August 2021 acquisition of Irisys, Societal CDMO has worked to integrate that business into its legacy operations. The result of these efforts has been the successful expansion of Societal CDMO’s physical footprint to include facilities on both coasts of the US, diversification of its customer base, expansion of its suite of service offerings, and enhancement of its industry expertise through augmentation of its leadership and employee base.
Source: Recro Pharma
Catalent Investing $30 M To Expand Drug-Product Mfg Facility
Catalent has completed a $30-million project at its facility in Limoges, France to transform the site into a European Center of Excellence for biopharmaceutical development, drug-product fill–finish services, and packaging.
The site will further expand Catalent Biologics’ global network, with early-phase integrated clinical development through to clinical supply services and small-scale commercial manufacturing, allowing tech transfer of projects as they progress to late-stage and larger-scale commercial supply from other Catalent manufacturing facilities in Europe and North America.
A new small-to-mid-scale flexible filling line has been installed, capable of handling vials, syringes, or cartridges under barrier isolator technology, and enhancements have been made to analytical and quality control laboratories, supporting clinical packaging, cold storage, and regulatory capabilities. It is envisaged that the expansion will create up to 80 additional jobs at the site.
ten23 health Expands Sterile Drug-Product Mfg Facility
ten23 health, a new Basel, Switzerland-based CDMO of injectable drugs, launched by 3i Group, a London-based investment group, has expanded its sterile drug-product manufacturing facility in Visp, Switzerland.
The site offers sterile manufacturing of pre-filled syringes, vials, and cartridges for clinical trial and market supplies. ten23 health acquired the facility when it acquired Swissfillon, a Visp, Switzerland-based drug-product CDMO specializing in sterile filling, in October 2021.
To enable further growth of its existing production capacity, ten23 health is investing in an expansion of supporting areas in an adjacent building. This expansion will provide an additional 1,000 square meters of clean-room space for visual inspection and cold storage and also include cleanroom space for additional services, such as supporting device assembly operations, labeling, and secondary packaging.
Source: ten23 health
Stevanato Group To Create Mfg Hub in China
Stevanato Group, a provider of drug-containment, drug-delivery and diagnostic products and services, has acquired a facility in Zhangjiagang, China to build an manufacturing hub. The company expects to begin renovations in the spring of 2022, as part of the latest phase of its expansion in China.
The new facility will be located near the company’s drug-containment solutions facility in the Jiangsu Zhangjiagang Economic and Technological Development Zone. The facility is expected to be up to 32,000 square meters, including engineering space. The company is expected to employ approximately 270 people in the China hub.
The facility will support production of high-value products, such as pre-sterilized EZ-fill syringes and vials, as well as a manufacturing area for visual inspection machines and glass-forming lines. Equipment production is expected to start in 2023, with the first EZ-fill lines due to be operative in early 2024.
In addition, the company expects to enlarge its current standard drug-containment product production in Zhangjiagang by increasing the size of the existing facility by approximately 7,000 square meters. This site is expected to almost double current production capabilities by the end of 2024.
Source: Stevanato Group
Thermo Fisher To Expand Clinical Research Lab Capacity
Thermo Fisher Scientific has announced plans to invest $97 million to expand its clinical research operations in Richmond, Virginia.
The facilities include laboratory operations acquired with the $17.4-billion purchase of PPD, a contract research organization, in December 2021.
Over the next three years (as reported on March 14, 2022), Thermo Fisher expects to add nearly 150,000 square feet and more than 500 new employees in Richmond. The existing laboratory services operation in Richmond comprises more than 300,000 square feet and employs more than 1,200 professionals. The bulk of the expansion will occur in immunochemistry and chromatography functions, as well as subsequent enhancements in biomarker and vaccine sciences.
Source: Thermo Fisher Scientific
Rentschler Biopharma, Vetter Name Strategic Alliance
Rentschler Biopharma, a Laupheim, Germany-based biologics CDMO, and Vetter, a Ravensburg, Germany-based CDMO of aseptic filling and packaging, have unveiled the name of their strategic collaboration, Xpert Alliance.In mid-2020, Vetter and Rentschler Biopharma formed a strategic collaboration to facilitate an integrated end-to-end service offering through the contribution of each company. Rentschler for biologics drug-substance development and manufacturing and Vetter for drug-product development and manufacturing.