The latest news from CDMOs, CMOs, and suppliers featuring Lonza, Alcami, GE Healthcare, Charles River, Hitachi, and Packaging Technology Group.

Biologics Manufacturing

GE Healthcare Life Sciences To Build New Facility for Single-Use Kits for Cell Processing

GE Healthcare Life Sciences is building a new 7,360-square-meter facility in Grens, Switzerland, in the new Signy Park, for the manufacture of single-use kits for its Sepax and Sefia cell-processing systems. The facility is expected to be fully operational in 2022.

The new facility will be able to house up to 200 employees. The new site will complement GE Healthcare Life Sciences’ global network of manufacturing facilities in the US, UK, Sweden, and China.

In addition to its manufacturing capabilities, the new site will house a Center of Excellence that will feature advanced cell and gene therapy manufacturing facilities and will also serve as a base for European customer trainings and educational initiatives. The site will also support a growing research and development team and other subject-matter experts.

Nemaco, a Dutch–Swiss based developer that specializes in made-to-measure buildings, will design and build the new facility.

Source: GE Healthcare Life Sciences

Hitachi, Ori Biotech Form Cell-and-Gene Therapy Services Pact

Hitachi Chemical Advanced Therapeutics Solutions (HCATS), a US subsidiary of Hitachi Chemical and a CDMO of cell-therapy products, and Ori Biotech, a CDMO of cell and gene therapies, have agreed to jointly develop and commercialize technology solutions specific to the cell and gene therapy industry.

The companies aim to combine HCATS’ experience in manufacturing and development with Ori Biotech’s proprietary cell and gene therapy manufacturing technology platform.

HCATS provides clinical manufacturing, commercial manufacturing, and manufacturing development services for cell therapies. It has facilities in New Jersey and California, with an expansion to add commercial manufacturing capabilities and capacity underway in New Jersey.

Source: Ori Biotech

Lonza, Chr. Hansen Name CEO of New JV CDMO Bacthera

Lukas Schüpbach has been appointed, effective February 1, 2020, as Chief Executive Officer (CEO) of Bacthera, a new joint venture company of Lonza and Chr. Hansen Holding, formed in 2019 as a CDMO providing services for live biotherapeutic products.

Bacthera’s interim CEO, Christian Bigum continues as acting CEO until Schüpbach takes up his new position on February 1, 2020.

Schüpbach was formerly head of Strategy and Operations at Emavant Solutions, was co-founder of Innojection, and has previously held senior leadership positions at Syngenta and Novartis. He holds a master’s degree in business from the University of Basel and a master’s degree in economics from the HEC in Lausanne, Switzerland.

Bacthera is headquartered in Basel, Switzerland with production facilities in Denmark and Switzerland.

Source: Lonza

Charles River to Expand Biologics Testing Services Site

Charles River Laboratories, a contract research organization, is expanding its biologics testing services site in Edinburgh, Scotland. GMP testing services located in Tranent, Scotland will be moving to Riccarton, New Zealand. The move will be fully complete by early 2020, and the new facility will have double the capacity for testing.

All current sponsor methods and staff will be moving to the Riccarton facility. Riccarton will continue to offer biosafety testing, cell-line characterization, contamination testing, bioassays, and vaccine-safety assays, along with lot release and stability assays. The company will be combining its traditional techniques on new applications and introducing new ones, such as multi-angle dynamic light scattering (MDLS), to provide a complete service offering.

Charles River also expanded its site in North America, with the addition of its Shrewsbury, Massachusetts site in 2018 and its Wayne, Pennsylvania site in 2019.

Source: Charles River Laboratories

Formulation Development/Drug Product Manufacturing

Alcami Acquires TriPharm To Expand Sterile Fill–Finish Capacity

Alcami, a CDMO of active pharmaceutical ingredients and drug products, has acquired TriPharm Services, a new CDMO formed in 2019 that has commissioned a new manufacturing center for sterile fill–finish services near Research Triangle Park, North Carolina. Alcami’s acquisition of TriPharm follows Alcami’s recently announced $17-million expansion of its sterile fill–finish facility in Charleston, South Carolina.

TriPharm’s facility adds to Alcami’s existing sterile fill–finish business by adding new prefilled- syringe capabilities and isolator technology as well as sterile fill–finish and lyophilization capacity.

TriPharm’s new manufacturing facility is expected to be operational beginning in the second half of 2020. TriPharm had announced the new 32,000-square-foot facility in October 2019. The manufacturing facility will offer four isolator filling suites and eight multi-purpose cleanrooms to support manufacturing operations.

In conjunction with this acquisition, funds affiliated with Madison Dearborn Partners, Alcami’s existing majority owner, made an additional equity investment to fund Alcami’s growth plan and the former majority owner of TriPharm, Ampersand Capital Partners, rolled a portion of its TriPharm ownership interest into an ownership interest in Alcami.

Source: Alcami, TriPharm Services

Packaging

Packaging Technology Group Opens Kentucky Facility

Packaging Technology Group (PTG), a provider of thermal packaging products for the biopharmaceutical and life-sciences sector, is opening a new manufacturing facility in Louisville, Kentucky. The new manufacturing facility is slated for completion in April 2020 and will add capacity and products to the company’s portfolio.

PTG offers temperature-sensitive thermal shipping solutions for pharmaceutical and biologics companies and develops, qualifies, and rolls out both custom and off-the-shelf shipping solutions. PTG recently launched its product line of thermo-efficient, 100% Curbside Recyclable, and environmentally sustainable solutions, TRUEtemp Naturals Cellulose. The TRUEtemp Naturals Cellulose shippers are designed with a curbside recyclable insulating fiber composed of layers that protect against impact and temperature fluctuation.

Source: Packaging Technology Group