Supplier News: Ampac, Thermo Fisher, West & More
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The latest from CDMOs, CMOs, and suppliers featuring Ampac Fine Chemicals, Thermo Fisher Scientific, West Pharmaceutical Services, Ashland, PCI Pharma Services, Evotec, Charles River Laboratories, Applied StemCell, Elevate Bio, Abec, and Phosphorex.

Chemicals/Chemical API Manufacturing
* Ampac Adds New Complex Molecule Chemistry & Engineering Center
* Evotec Acquires API Manufacturer Central Glass Germany
Biologics Mfg
* Thermo Fisher Opens Viral Vector Mfg Facility
* Thermo Fisher Opens $105-M Single Use Technology Mfg Site
* Charles River Adding Vivarium Space
* Applied StemCell Expanding Cell, Gene-Therapy Mfg
* ElevateBio, University of Pittsburgh, Partner for $100-M Cell, Gene Therapy Mfg Center
* ABEC Investing $11 M in Single-Use Mfg Expansion
Formulation Development/Drug Product Manufacturing
* Ashland To Expand Excipient Mfg in Ireland
* Phosphorex To Establish Lipid Nanoparticle Mfg
Packaging
* PCI Pharma Opens Clinical Services Center of Excellence
* West Investing $60 M to Expand Mfg Facility


Chemicals/Chemical API Manufacturing

Ampac Adds New Complex Molecule Chemistry & Engineering Center
AmpacFine Chemicals, part of SK pharmteco, a CDMO of active pharmaceutical ingredients, has added a new Complex Molecule Chemistry & Engineering Center at its site in Rancho Cordova, California. The new center provides news capacity and advances continuous processing technologies.

Source: SK pharmteco


Evotec Acquires API Manufacturer Central Glass Germany
Evotec, a Hamburg, Germany-based drug-discovery and development company, has completed its acquisition of Central Glass Germany, a manufacturer of small molecule active pharmaceutical ingredients (API), from Central Glass Co., a Japanese chemical manufacturing company

Going forward, Central Glass Germany will operate as Evotec Drug Substance (Germany). The company is located on a pharmaceutical manufacturing campus in Halle/Westphalia, Germany and is operating with a team of roughly 60 chemical manufacturing staff. The facility has over 53,000 square feet of floor space for drug-substance manufacturing.

Source: Evotec


Biologics Manufacturing

Thermo Fisher Opens Viral Vector Mfg Facility
Thermo Fisher Scientific has opened a new 300,000-square-foot viral vector manufacturing facility in Plainville, Massachusetts. The site will add approximately 300 jobs to support the development, testing, and manufacture of viral vectors. The facility expands the company’s clinical and commercial viral vector capacity to six sites in the US and Europe. It features sustainable construction design, laboratory and production suites, adjacent warehousing, and office space, as well as the company’s bioproduction and analytical instrumentation technologies.

Source: Thermo Fisher Scientific


Thermo Fisher Opens $105-M Single-Use Technology Mfg Site
Thermo Fisher Scientific has opened a $105-million, 400,000-square-foot single-use technology manufacturing site in Lebanon, Tennessee. The new site is part of Thermo Fisher’s $650-million multi-year investment to expand its bioprocessing production capabilities.

The Lebanon facility will manufacture customizable, single-use bioprocess containers and fluid- transfer assembly systems. The completed site will include 92,000 square feet of cleanrooms. The Lebanon site currently employs approximately 300 people (as reported on August 22, 2022), and the completed facility will create 1,400 new jobs in roles across engineering, procurement, quality, warehousing, site leadership and more.

Source: Thermo Fisher Scientific


Charles River Adding Vivarium Space 
Charles River Laboratories plans to add five Charles River Accelerator and Development Lab (CRADL) locations in California and Washington to provide turnkey vivarium rentals supported by Charles River’s technical and veterinary support expertise in key biohubs.

As part of its recent acquisition of Explora Biolabs, the company is adding two additional facilities in San Diego. Additionally, CRADL has added additional facilities in South San Francisco and a new location in Thousand Oaks, California.

Source: Charles River Laboratories


Applied StemCell Expanding Cell, Gene-Therapy Mfg
Applied StemCell, a Milpitas, California-based cell- and gene-therapy CRO/CDMO, is expanding to add four additional cGMP cleanrooms, cryo-storage space, and a process development and quality control/quality assurance space. The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow the company to work simultaneously on multiple manufacturing projects, such as Induced pluripotent stem cells generation, gene editing, differentiation, and cell-bank manufacturing.

Construction will begin within the next month (as reported on August 29, 2022), and the company has already begun the staff hiring process. The expansion is expected to be completed early next year (2023).

Source: Applied StemCell


ElevateBio, University of Pittsburgh, Partner for $100-M Cell, Gene Therapy Mfg Center
ElevateBio, a Massachusetts-based CMO of cell and gene therapies, and the University of Pittsburgh have entered into a long-term strategic partnership under which ElevateBio will locate a $100-million process development and GMP manufacturing facility in Pittsburgh, Pennsylvania. Funding for the project is through a $100-million grant by the Richard King Mellon Foundation to the University of Pittsburgh in November 2021 to create the Pitt BioForge BioManufacturing Center.

The facility will be equipped with enabling technologies, including gene editing, induced pluripotent stem cell, and cell, vector, and protein engineering capabilities. The new facility is expected to generate more than 170 permanent full-time jobs, 900 construction jobs, and 360 off-site support jobs.

Source: ElevateBio


ABEC Investing $11 M in Single-Use Mfg Expansion
ABEC, a Bethlehem, Pennsylvania-based engineering, equipment, and services provider, plans to invest $11 million to expand single-use disposable container manufacturing capacity for its proprietary Custom Single Run single-use systems at its facility in Wilson, North Carolina.

The investment includes a 50,000-square-foot facility on 13 acres, which will be outfitted with an ISO-7 cleanroom and manufacturing equipment. The new facility will be the company’s third global facility and is expected to be fully operational early in the second quarter of 2023. ABEC currently supplies single-use disposable containers globally from its ISO-7 cleanrooms in Fermoy, Ireland, and from its headquarters in Bethlehem, Pennsylvania.

Source: ABEC


Formulation Development/Drug Product Manufacturing

Ashland To Expand Excipient Mfg in Ireland
Ashland, a manufacturer of excipients and other chemicals, has begun an expansion of its Viatel bioresorbable polymer manufacturing and research and development site in Mullingar, Ireland. Viatel bioresorbable polymers are used in long-acting release formulations, bioresorbable medical devices, and tissue-engineering scaffolds.

Source: Ashland


Phosphorex To Establish Lipid Nanoparticle Mfg
Phosphorex, a Hopkinton, Massachusetts-based drug delivery-focused CDMO of microspheres and polymer and lipid nanoparticles, has secured funding from Ampersand Capital Partners, a private equity firm, which will be used to build out the company’s 30,000-square-foot-facility in Hopkinton, Massachusetts and establish cGMP manufacturing capabilities. The expansion will include the construction of multiple cGMP production suites, processing and packaging capabilities, and comprehensive process development and analytical testing services.

Source: Phosphorex


Packaging

PCI Pharma Opens Clinical Services Center of Excellence
PCI Pharma Services, a CDMO of drug products and contract packager has opened a Clinical Services Center of Excellence in Bridgewater, Massachusetts, for secondary packaging, distribution, and cold-chain storage.

The facility has a capacity for a -20°C freezer, 35 ultra-low temperature freezers at -80°C, and 12 liquid nitrogen freezers. It also features a temperature-controlled room containing a 5,000- square-foot cooler at 2° to 8°C, each with five levels of warehouse racking. A 1,000-square-foot cold secondary packaging room will eventually be converted to primary packaging with the planned construction of an additional secondary packing unit.

Source: PCI Pharma Services


West Investing $60 M to Expand Mfg Facility
West Pharmaceutical Services, a provider of injectable drug-administration and delivery products and services, is investing $60 million to expand its Jersey Shore, Lycoming County, Pennsylvania-based manufacturing facility by increasing production capacity and providing additional floor space.

The expansion also involves West’s expansion of the company’s  back office, administrative, and research and development services at its corporate headquarters in Exton, Chester County, Pennsylvania. As a result, the company will create 225 new full-time jobs between the Jersey Shore and Exton locations.

Source: Pennsylvania’s Office of the Governor