Carbogen Amcis, CordenPharma, Novasep, PHT, Cambrex, Catalent Expand

The latest from CDMOs, CMOs, and suppliers featuring Carbogen Amcis, CordenPharma, Novasep, PHT, Cambrex, Catalent, Aenova, Enteris BioPharma, and NJ Biopharmaceuticals.

Chemicals/Chemical API Manufacturing

Carbogen Amcis To Expand Swiss Site with $16-M Co-Investment
Carbogen Amcis, a Bubendorf, Switzerland-based CDMO of active pharmaceutical ingredients (APIs) and drug products, has announced a CHF 15-million ($16-million) joint funding agreement with an undisclosed Japan-based customer to expand its site Bubendorf, Switzerland.

The expansion will be created adjacent to an existing manufacturing facility on the Bubendorf site and will incorporate a new production line comprising of two 850-L reactors and one agitated filter drier. The facility is designed for highly potent manufacturing up to Category 4 (occupational exposure limit of 1 µg/m³ and lower).

Carbogen Amcis will produce exclusively for the signatory customer a complex highly potent drug component for a commercial antibody-drug-conjugate active pharmaceutical ingredient. Currently, the planning phase for the building extension is underway, and the company expects to commence operations in the autumn of 2022.

Source: Carbogen Amcis

CordenPharma To Expand Peptide Purification Suite in Colorado
CordenPharma has announced plans to add a second 100-cm high-pressure chromatography column for peptide purification at its facility in Boulder, Colorado. The new column is already installed and will be qualified by the end of second quarter of 2021. The additional column will provide the capacity to purify several tons of peptide annually, which will add to the company’s existing 100-cm and 80 cm columns for peptide purification at the site.

The expansion follows recent investment in peptide manufacturing. In the fourth quarter of 2020, CordenPharma announced an expansion of non-GMP capacity at its Center of Excellence for Peptide Process Development in Frankfurt, Germany, and an increase in upstream capacity with the introduction of a new 3,000-L solid phase peptide synthesis vessel at its site in Colorado.

Source: CordenPharma

Novasep To Expand HPAPI Mfg Capacity
Novasep plans to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capacity at its site in Le Mans, France site.

Novasep is investing more than EUR 4 million ($4.8 million) to increase clinical and commercial production capacity and is recruiting more than 30 people to the site.

Source: Novasep

PHT International Expands Operations in China
PHT International, a Charlotte, North Carolina-based CDMO of pharma intermediates and active pharmaceutical ingredients (APIs), has increased its operations in China with the acquisition of a China-based CRO, Basilea Pharmaceutica China, and with the expansion of its chemical manufacturing facility in Zheijang, China.

In March (March 2021), PHT acquired Basilea Pharmaceutica’s Chinese R&D subsidiary, Basilea Pharmaceutica China, to add further capabilities in chemical synthesis, analytical development, and process research and development.

Additionally, PHT has expanded capacity of its chemical manufacturing facility in Zhejiang, China, Zhejiang PHT Pharmaceutical, with the addition of a new workshop. Infrastructure construction started in 2020, and the expansion came on line in the first quarter of 2021.

The G-4 Workshop area includes four segregated synthesis areas, a solvent-recovery area, a commercial flow reactor for nitration, a hydrogenation area, one cleanroom area, and one control-room area.

Source: PHT International

Cambrex To Expand Analytical Testing Capabilities
Cambrex has announced plans to expand its analytical testing capabilities at its site in Longmont, Colorado. Existing space at the site has been repurposed with technologies and doubles the footprint of laboratory operations.

The facility will gain approximately 1,800 ft2 of laboratory space with an improved design across an open module layout for efficiency. The expansion includes the addition of chromatographic equipment and dissolution equipment as well as additional laboratory support equipment, including 10 chemical fume hoods and working bench space.

The Longmont facility became part of the Cambrex following the company’s 2019 acquisition of Avista Pharma Solutions, a Durham, North Carolina-headquartered contract testing, development, and manufacturing organization. The site allows for the development and manufacture of small-molecule drug substances and drug products and provides analytical development and cGMP testing support from discovery through to clinical scale. The site is integrated with direct technical transfer lines for commercial-scale advancement to Cambrex’s sites in Charles City, Iowa, Mirabel, Québec, Canada, and Whippany, New Jersey.

Source: Cambrex

NJ Biopharmaceuticals Moves HQ to Former BMS Site
NJ Biopharmaceuticals, a provider of chemistry and biopharmaceutical services specializing in bioconjugation, custom synthesis, flow chemistry, and process development, has moved its headquarters from North Brunswick, New Jersey to Princeton, New Jersey.

The 35,000-square-foot laboratory space will be located at a site formerly occupied by Bristol Myers Squibb. Over time, the company plans to expand further within the same location. Current staff will move from North Brunswick to Princeton, and the facility will be fully operational by July 1, 2021. The company will continue to operate its facility in Bristol, Pennsylvania, with plans for future growth at that site, including GMP manufacturing capabilities for small molecules as well as bioconjugation.

Source: NJ Biopharmaceuticals

Biologics Manufacturing

Catalent Acquires Additional Facility for Plasmid DNA Mfg
Catalent has acquired Hepatic Cell Therapy Support (HCTS), the cell-therapy manufacturing subsidiary of Promethera Biosciences, a Mont-Saint-Guibert, Belgium-based company. The acquisition includes a 32,400-square-foot facility in Gosselies, Belgium.

The facility will support Catalent’s commercial-scale plasmid DNA (pDNA) manufacturing and add to the company’s capabilities in pDNA services. Earlier this year (2021) Catalent acquired Delphi Genetics, a Gosselies, Belgium-based pDNA cell-and gene-therapy CDMO.

The HCTS facility houses an existing cleanroom infrastructure, process development capabilities, quality-control laboratories, and warehouse space and will be equipped to provide pDNA manufacturing up to the 500-liter scale. This new facility is located on Catalent’s existing campus in Gosselies, adjacent to the Delphi Genetics building. Since the purchase of MaSTherCell in March of 2020, this acquisition is the third that Catalent has made at its Gosselies location and further expands its cell- and gene-therapy European Center of Excellence.

Fitting out the facility is expected to begin immediately (as reported on May 6, 2021), and will create more than 200 technical, scientific, and operational new employment positions over the next five years.

Alongside this new expansion in Gosselies, Catalent will also offer commercial-scale pDNA production capabilities at its Rockville, Maryland facility with the addition of 500-liter scale bioreactor capacity.

Source: Catalent

Formulation Development/Drug-Product Manufacturing

Aenova To Invest $19.4 M To Expand Fill–Finish Capacity
Aenova, a Starnberg, Bavaria-based CDMO of sterling manufacturing, has announced plans to build a new sterile production area at its site in Latina, Italy to expand its fill–finish capacity for the production of biologics, including COVID-19 vaccines.

The company is investing EUR 16 million ($19.4 million) for a new fill–finish area for vials and prefilled syringes with high-speed filling lines, including compounding. The first line to be installed has a capacity of more than 80 million vials (glass and plastic) and over 180 million prefilled syringes per year. Aenova is also planning a phased capacity expansion of this new area with up to three additional high-speed filling lines.

The company’s site in Latina is one of the largest production facilities in the Aenova Group with approximately 600 employees.

Source: Aenova

Enteris Biopharma Completes Mfg Expansion, Launches CDMO Business
Enteris BioPharma, a company specializing in oral peptide drug-delivery technology, has completed the expansion of its Boonton, New Jersey manufacturing facility and launched a CDMO business segment for the formulation, development and manufacturing of solid oral doses for difficult-to-formulate Biopharmaceutics Classification System (BCS) III and IV compounds, including peptides and highly potent compounds.

The expanded 32,000-square-foot facility includes 6,000 square feet of cleanroom space with approximately 2,500 square feet dedicated to the containment and processing of high potency active pharmaceutical ingredients (HPAPI)

The manufacturing plant’s containment area is designed to handle highly potent APIs. Depending on the solid oral dosage unit’s physical characteristics, batch sizes can vary from a few hundred to hundreds of thousands of dosage units. The facility also includes 1,700 square feet of flexible suite space that can be adapted to a partner’s development and manufacturing needs.

The CDMO business segment will provide custom solutions for the formulation, development and manufacturing of solid oral doses for difficult-to-formulate BCS III and IV compounds, including peptides and highly potent compounds.

Source: Enteris BioPharma

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