The latest from CDMOs, CMOs, and suppliers featuring Grand River Aseptic Manufacturing & Selkirk Pharma.  

Formulation Development/Drug Product Manufacturing 
* GRAM Completes Expansion of Finishing & Warehouse Center 
* Selkirk Pharma Announces APS Qualification of Sterile Mfg Facility 

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Formulation Development/Drug Product Manufacturing 

GRAM Completes Expansion of Finishing & Warehouse Center 
Grand River Aseptic Manufacturing (GRAM), a CDMO of parenteral drug products, has completed an expansion of its finishing and warehouse center.  

The expansion added 90,000 square feet to an existing 110,000 square feet of inspection, packaging, testing, and warehouse space. The center incorporates the following: (1) four fully automated inspection systems, eight semi-automated, and 12  manual inspection booths; (2) four labeling and packing lines with future label and pack space; (3) two autoclaves for product terminal sterilization; (4) quality control analytical and sterility lab with sterility isolators to support lyophilized, biologics, and small-molecule product testing; (5) three -50°C walk-in freezers and three walk-in finished-product refrigerated frozen units (2–8°C and -20°C); (6) 30,000 square feet reserved for additional syringe-/cartridge-filling lines; and (7) over 50,000 square feet of material and finished product storage. 

Source: Grand River Aseptic Manufacturing 

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Selkirk Pharma Announces APS Qualification of Sterile Mfg Facility 
Selkirk Pharma, a CDMO of fill–finish services, has announced the aseptic process simulation qualification of its sterile manufacturing facility and newly available fill–finish capacity in Spokane, Washington.  

The facility operates with technology, including unidirectional material and personnel flow, single-use systems, SKAN isolator technology, and VarioSys advanced dose-filling systems.  

Source: Selkirk Pharma