DSM is a global leader in the manufacture of sterile dosage form pharmaceuticals, comprising aseptic liquid filling, cytotoxic formulation and filling, and lyophilization.
Aseptic liquid filling
DSM offers aseptic liquid filling using a proprietary, flexible, state-of-the-art distributed control system called LiquidAdvantage™. This is used on all filling lines operating under aseptic production methods, and controls SCADA, D3 and electronic cycle run report functions in a single unified solution.
Utilizing a product-specific, recipe-driven single communication interface, all production operations from supply and filling to packaging and warehousing occur with minimal interaction from production staff, which increases sterility assurance. Automated production controls also enhance product quality from the outset.
LYOADVANTAGE™ Lyophilization Services
DSM offers pharmaceutical and biopharmaceutical customers a lyophilization system with unique benefits. It has the precision to serve increasingly demanding lyophilization cycles – a critical requirement for successful product launches and high commercial yields.
Our LYOADVANTAGE™ lyophilization services utilize lyophilizers that range in size from 8 to 640 square feet, and are equipped with proprietary software for cycle control, which provides the accuracy necessary for high-value products. A key benefit is the ability to efficiently scale up from an 8-square foot, non-cGMP unit to any commercial unit (up to 640 square feet).
Cytotoxic formulation and filling
As a global leader in the manufacture of commercial-scale sterile pharmaceuticals, a logical step for us was to expand this offering to filling and lyophilization of cytotoxic products. Originally requested by our customers and now implemented since early 2008, this represents another valuable integrated service from DSM.
Our cytotoxic services are flexible, with complete aseptic liquid filling and lyophilization capabilities, variable batch sizes, options for expanded development and analytical services, and adaptable scheduling. Our Greenville facility also received Potent Compound Safety Certification from SafeBridge Consultants, Inc.
Sterile clinical trial material formulation and filling
Sterile clinical trial formulation and filling is also a unique niche served by DSM at Greenville. It meets the needs of global pharmaceutical and biotech companies for projects in post-discovery, cGMP phases I-II, or ready for commercial manufacturing. We have all the resources necessary to provide assured delivery. Our account managers and R&D experts offer extensive experience in CTM services and global delivery.
