PARENTERAL DOSAGE FORMS
Ascendia manufactures cGMP clinical batches of injectable dosage forms for early-stage clinical studies. Production of the first clinical trial materials for a new pharmaceutical dosage form is a significant milestone event in the development of a pharmaceutical product. FDA has provided guidance on the quality and safety of Phase I investigational drugs, stating that during product development this is maintained, in part, by having appropriate quality control procedures in effect, and following appropriate cGMP which will facilitate the manufacture of equivalent or comparable IND product for future clinical trials as needed.
Ascendia manufactures sterile, injectable clinical trial materials in its Class 100 (ISO 5) clean room, and can also conduct aseptic processing using isolator systems which minimizes the extent of personnel involvement and separates the external cleanroom environment from the aseptic processing line. A very high level of integrity can be achieved using isolators for aseptic processing. We maintain dedicated, self-contained cleanrooms for conducting sterile manufacturing and fill processes for our clients. The option for terminal sterilization by autoclave is also available.
Ascendia also specializes in the production of sterile, dispersible dosage forms include suspensions, nano-particles and nano-emulsions – these last two formulation options are being increasingly utilized due to their ability to improve bioavailability issues with poorly soluble drugs.
While the basic requirements to reduce or eliminate contamination that would cause adulteration in non-sterile drug products are demanding, the standards for aseptic manufacturing of medicinal drug products are even more stringent. The pharmaceutical product must be non-pyrogenic, in addition to a strict sterility requirement. Medicinal drug products that do not meet the sterility and non-pyrogenicity requirements can otherwise cause severe harm or a life-threatening health risk to the patient. Hence, these attributes are of utmost importance and concern during Phase 1 manufacture.
Ascendia is committed to providing RAPID, COMPREHENSIVE & COST-EFFECTIVE formulation development and clinical manufacture for your drug project – contact us to learn more.
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