AGC Acquires Former Novartis Mfg Facility; BI, GRAM Expand

The latest from CDMOs, CMOs, and suppliers featuring AGC Biologics, Boehringer Ingelheim (BI), Grand River Aseptic Manufacturing (GRAM), Evonik, Rentschler Biopharma, Aphena, and others.

Chemicals/Chemical API Manufacturing

Heraeus Expands Capacity for Platinum-Based APIs
Heraeus Pharmaceutical Ingredients, part of Heraeus, a Hanau, Germany-based technology group, reports that its new production line for platinum-based active pharmaceutical ingredients (APIs) at its headquarters in Hanau is operational with deliveries of APIs already made to customers.

Building of the new production line began at the end of 2018 and was part of a multi-million euro investment, as reported by the company.

Source: Heraeus

Biologics Manufacturing

AGC Biologics Acquires Former Novartis Mfg Facility
AGC Biologics, a contract biologics manufacturer, has acquired a commercial manufacturing facility in Longmont, Colorado, previously owned by Novartis Gene Therapies.

The facility adds 622,000 square feet of operations and office space primarily planned for cell-and gene-therapy activities. The facility is expected to begin full-scale operations by the fourth quarter of 2021 and is near AGC Biologics’ large-scale stainless-steel mammalian biomanufacturing facility in Boulder, Colorado.

In addition to this facility acquisition, AGC Biologics previously announced cell- and gene-therapy facility expansion projects at its Heidelberg, Germany and Milan, Italy facilities in 2020 and 2021, respectively.

Source: AGC Biologics

BI To Inaugurate New Biomanufacturing Facility in Austria
Boehringer Ingelheim (BI) reports that the company will inaugurate its large-scale, cell-culture biomanufacturing facility in Vienna, Austria, in October (October 2021), which includes up to 150,000 L manufacturing capacity for BI products and contract manufacturing activities. The company provided the update in its second-quarter 2021 earnings release on August 3, 2021.

Source: Boehringer Ingelheim

Just–Evotec Biologics Opens Biomanufacturing Facility
Just–Evotec Biologics, a technology platform company for the development and manufacture of biologics, and a wholly owned subsidiary of Evotec, has opened a late-stage clinical and commercial biologics cGMP manufacturing facility, called J.POD 1 US, in Redmond, Washington.

The 130,000-square-foot site includes quality control and process development laboratories for both clinical and commercial products, a warehouse, and collaborative office and meeting spaces for approximately 200 employees at full capacity.

The company’s existing Seattle, Washington facility, which includes discovery and development labs and an early clinical phase manufacturing plant, will continue to operate as part of Just–Evotec Biologics’ J.DESIGN services.

At its two sites in Washington, Just–Evotec Biologics currently employs more than 250 workers, and is expected to grow to approximately 300 by the end of 2021. The first manufacturing runs for its partner, the US. Department of Defense, are due to be initiated in November 2021.

Source: Just–Evotec Biologics

Rentschler Biopharma Breaks Ground for New Biomanufacturing Center
Rentschler Biopharma, a biologics CDMO, has broken ground at its new production site, adjacent to its existing site in Milford, Massachusetts. The new Rentschler Biopharma Manufacturing Center US will add 22,000 square feet of manufacturing cleanroom space and house four new 2,000-L single-use bioreactors. It is expected to become operational in late 2023.

Source: Rentschler Biopharma

Precision NanoSystems Plans New HQ, Facility for RNA Mfg
Precision NanoSystems (PNI), a Vancouver, Canada-based company focused on technologies for nanomedicines, has announced plans for a new 75,000-square-foot facility for its new global headquarters and multiple suites for manufacturing RNA therapeutics and vaccines

Currently under construction and slated for completion in the fourth quarter 2022, the new site will be located in the False Creek Flats area of Vancouver. PNI’s new genetic medicine Biomanufacturing Center will also be housed at the site. The Biomanufacturing Centre has been partially funded with Can$ 25.1 million (US $20 million) from Canada’s Strategic Innovation Fund.

PNI also provides development and manufacturing of lipid nanoparticles for the delivery of genetic medicines, including mRNA. In June (June 2021), Danaher Corporation acquired PNI.

Source: Precision NanoSystems

BioLife To Acquire Sexton Biotechnologies
BioLife Solutions, a Bothell, Washington-based supplier of cell- and gene-therapy bioproduction tools and services, has agreed to acquire Sexton Biotechnologies, a biotechnology company focused on the development of bioproduction tools for cell and gene therapies.

Sexton’s bioproduction tools portfolio includes closed vials for cell-therapy final dose packaging, human platelet lysate media, a bio-defined replacement for fetal bovine serum or human serum used in cell manufacturing, and automated cell-processing machines.

The transaction is expected to close on or before September 1, 2021. BioLife plans to retain all Sexton team members and its current facility in Indianapolis, Indiana.

Source: BioLife Solutions and Sexton Biotechnologies

Formulation Development/Drug-Product Manufacturing

Grand River Aseptic Opens New Fill-Finish Mfg Center
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has opened a new finishing manufacturing facility and warehouse center.

The building is the company’s fourth manufacturing facility and adds an additional 110,000 square feet to GRAM’s footprint. The facility features: four inspection rooms; four finishing rooms; a quality control laboratory; a weigh and dispense cleanroom; walk-in coolers/freezers; walk-in incubators; an incoming and outgoing warehouse; and multiple truck bays.

In addition, GRAM has invested in advanced finishing equipment, including a new MG America labeling machine with a Dividella packaging line, and two Stevanato automated inspection systems.

The new facility marks the latest milestone in GRAM’s goals to increase capacity and throughput. The company is currently on its Phase II expansion of its large-scale fill–finish facility and has invested in a duplicate Bausch+Ströbel vial filler with SKAN Isolator technology as well as a VarioSys syringe and vial filler to further increase capacity.

Source: Grand River Aseptic Manufacturing

Frontage Labs Completes Construction of New Lab Facility
Frontage Laboratories, an Exton, Pennsylvania-headquartered contract research organization, has completed construction of a new 71,000-square-foot laboratory facility in Exton, Pennsylvania to support CMC (chemistry, manufacturing and controls) and biologics services as well as new central laboratory services. In addition, the company’s pharmaceutical analysis laboratory has relocated to this location allowing for an increase in capacity by 50%.

Source: Frontage Laboratories

Evonik Completes Acquisition of JeNaCell
Evonik, a producer of specialty and fine chemicals and biomaterials, has acquired JeNaCell, a Jena, Germany-based biotechnology company.

JeNaCell began as a spinoff company from the Friedrich-Schiller-University of Jena, Germany. In 2017, the company launched its first product, epicite, a medical wound dressing for the treatment of chronic wounds, surgical wounds, and burns, based on biotechnologically derived cellulose. Further technologies developed by JeNaCell include soft tissue implants, transdermal delivery systems, and dermatological applications.

The employees of JeNaCell will continue to work at the development and production site based in Jena, Germany.

Source: Evonik

Croda Expands Excipients Mfg Facility
Croda International, a producer of oleochemicals, excipients, and other ingredients, has expanded its high-purity excipients facility in Mill Hall, Pennsylvania.

This latest expansion will focus on producing high-purity pharmaceutical ingredients used in solid-oral dose products, topicals, biologics, and vaccines. The expansion will nearly double Mill Hall’s capacity to produce these ingredients.

Source: Croda International


Aphena Launches New Third-Party Logistics Division
Aphena Pharma Solutions, a CDMO and provider of contract packaging services, has launched a new Third-Party Logistics (3PL) Division, which will be based at the company’s campus in Cookeville, Tennessee.

Aphena’s 3PL logistics services and capabilities will include: (1) full distribution services (receipt, storage and order fulfillment); (2) order-to-cash services (accounts receivable, invoicing, chargebacks and month-end close); (3) controlled room temperature (CRT) storage; (4) Drug Enforcement Administration (DEA) Schedule II (vault) and DEA schedule III-V storage; and (5) cold chain, 2-8º Celsius storage. The National Association of Boards of Pharmacy’s Drug Distributor Accreditation (VAWD) certification is in progress.

Aphena plans to complete development of the new division by the end of 2021 and to begin 3PL service in early 2022.

Source: Aphena Pharma Solutions

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