The latest from CDMOs, CMOs, and suppliers featuring Lotte Biologics, Cambrex, Thermo Fisher Scientific, Eurofins CDMO Alphora, Genezen/uniQure, Rentschler Biopharma and Selkirk Pharma.

Chemicals/Chemical API Manufacturing
* Eurofins CDMO Alphora Completes New API Mfg Facility
Biologics Manufacturing
* Lotte Biologics Breaks Ground on New Biomanufacturing Facility
* Genezen To Acquire Gene-Therapy Mfg Facility from uniQure
* Rentschler Biopharma Completes New Production Line
Formulation Development/Drug Product Manufacturing
* Selkirk Names New CEO
General
* Cambrex To Open New Storage Facility
* Thermo Fisher Completes $3.1-Bn Acquisition of Proteomics Company Olink

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Chemicals/Chemical API Manufacturing

Eurofins CDMO Alphora Completes New API Mfg Facility
Eurofins CDMO Alphora, a Mississauga, Canada-based CDMO of active pharmaceutical ingredients (APIs) and drug products, has completed an expansion of its API manufacturing site in Mississauga, Canada, with the addition of a new facility at its site. The new API facility adds 15,000 square feet of GMP processing and warehousing space, which complements Eurofins CDMO Alphora’s existing API and drug-substance manufacturing capabilities.

The addition of 2 x 2,000-L reactors expands the company’s existing GMP plant capacity and supports API batches to the 125-kg scale. The new plant provides additional capacity for Phase I through to commercialization programs and is designed to handle up to Safebridge Class 3 compounds and includes two Hastelloy filter dryers to facilitate API isolation and drying. The reactor systems can support temperatures from cryogenic (-800 degrees Celsius to 2,000 degrees Celsius) as well as hydrogenation and biotage chromatography.

Source: Eurofins CDMO Alphora

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Biologics Manufacturing

Lotte Biologics Breaks Ground on New Biomanufacturing Facility
Lotte Biologics, a CDMO of biologics, has broken ground on its inaugural plant at its Songdo Bio Campus in Incheon International City, South Korea, the first plant of a $3.3-billion biocampus that the company is establishing.  

Lotte Biologics entered the CDMO market with the acquisition of a commercial-scale biomanufacturing facility in Syracuse, New York, from Bristol-Myers Squibb in January 2023. The new facility is part of a previously announced $3.3-billion expansion plan to build three biomanufacturing plants at a new biocampus in South Korea by 2030 that will provide total production capacity of 360,000 liters, with each plant having 120,00 liters of production capacity. The new biocampus spans 202,285 square meters. Lotte Engineering & Construction will spearhead the design, procurement, and construction of the first plant.

Source: Lotte Biologics

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Genezen To Acquire Gene-Therapy Mfg Facility from uniQure
Genezen, an Indianapolis, Indiana-based CDMO of cell and gene therapies, has agreed to acquire a gene-therapy manufacturing facility from uniQure, a Lexington, Massachusetts-based bio/pharma company specializing in cell and gene therapies, for $25 million.

Genezen has agreed to acquire the manufacturing equipment and related manufacturing operations along with certain other assets associated with the Lexington facility. Genezen agreed to extend offers of employment to a majority of the uniQure employees currently located at the facility. In addition, uniQure’s Chief Executive Officer, Matt Kapusta, will join the Board of Directors of Genezen in connection with the closing of the transaction, which is expected to occur in the third quarter of 2024.

Source: uniQure

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Rentschler Biopharma Completes New Production Line
Rentschler Biopharma, a Laupheim, Germany-based CDMO of biologics, has announced that the company’s new production line at its facility in Milford, Massachusetts, is now fully operational.

The groundbreaking took place in August 2021, during the COVID-19 pandemic, and the first engineering run of a 2,000-L batch has been recently completed. With this, the line is now fully up and running. The multi-product facility, which doubles Rentschler Biopharma’s global cGMP capacity, is focusing mainly on commercial production of highly complex molecules. The original Milford site went from a single-product commercial facility to producing multiple products in an up to 500-L-bioreactor setup. The new production line has added 22,000 square feet of manufacturing cleanroom space and houses four new 2,000-L single-use bioreactors, bringing the total production lines at the site up to three.

Source: Rentschler Biopharma

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Formulation Development/Drug Product Manufacturing

Selkirk Names New CEO
Selkirk Pharma, a CDMO of fill–finish services, has named Colleen Dixon, formerly Vice President of Program Management at Selkirk Pharma, as the company’s new CEO. She succeeds Patrick Haffey, the founder of Selkirk Pharma and who has served as the company’s Chairman and CEO for the past six years.

Dixon has more than 30 years of experience in the bio/pharmaceutical industry, having held senior leadership roles at AstraZeneca, Baxter BioPharma Solutions, and Eli Lilly and Company. Her most recent role prior to joining Selkirk, was as Head of Bio/Pharmaceutical Project Management at AstraZeneca.

Source: Selkirk Pharma

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General

Cambrex To Open New Storage Facility
Cambrex a CDMO of small-molecule active pharmaceutical ingredients, has announced that its stability storage business, Q1 Scientific, will open a new facility in Durham, North Carolina, before the end of 2024, featuring advanced storage capabilities.

The new Durham facility will initially offer seven ICH stability chambers, covering a range of conditions, including 2-8°C, 25°C/40 % relative humidity (RH), 25°C/60 % RH, 30°C/65 % RH, and 40°C/75% RH, as well as both -20°C and ultra low (-70°C/-80°C) storage conditions. The Phase 2 expansion will increase the facility’s capacity to 20 chambers, with the potential for 20,000 cubic feet of storage space when complete.

Source: Cambrex

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Thermo Fisher Completes $3.1-Bn Acquisition of Proteomics Company Olink
Thermo Fisher Scientific has completed its $3.1-billion acquisition of Olink Holding, a provider of proteomics services supporting drug discovery and drug development. The companies had announced the acquisition last October (October 2023).

Source: Thermo Fisher Scientific