SPECIALIZED CONTAINMENT TO ENSURE SAFETY & REGULATORY COMPLIANCE
For products requiring complex handling, such as cytotoxics and highly potent compounds, we use open or closed RABS (restricted access barrier system) technologies, as appropriate. These manufacturing environments are designed to provide containment during filling operations and to ensure that we are compliant with all safety and regulatory requirements.
HANDLING HIGHLY POTENT COMPOUNDS
For extremely sensitive highly potent compounds, we maintain a cRABS manufacturing environment and isolators, which help to preserve the integrity of these drug molecules, enhance product sterility and ensure the safety of the line operators. The cRABS manufacturing areas have independent air supply and waste disposal systems, including 100% waste collection. Operators in these areas are highly trained and experienced, with expertise in carcinogenic, mutagenic and reprotoxic products. They use special equipment, observe robust standard operating procedures and conduct rigorous risk assessments.
Our Halle/Westfalen and Bloomington facilities are cGMP compliant, have environmental health and safety certification according to ISO 14001, and meet FDA (United States), PDMA (Japan) and EMA (European Union) regulatory standards. In addition, the Halle/Westfalen facility is SafeBridge-certified for drug substance synthesis and parenteral drug product manufacturing and testing.
With the advent of more product niches and often lowered production quantities, facilities that are experienced and versatile in handling cytotoxic, highly potent, and non-cytotoxic oncology products can present a valid option.View resource
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Simtra BioPharma Solutions (Simtra) is a premier CMO with a singular focus on sterile injectable drug product form/fill/finish services.View resource