Aseptic Manufacturing of Parenteral Drug Products
Aseptic drug manufacturing of parenteral drug products
With more than 30 years of experience in the development of parenteral drug products, we are able to support your programs from candidate development through clinical trial manufacturing via aseptic filtration techniques. Our innovative approach enables rapid development and manufacturing of sterile solution formulations for parenteral administration, with a strong emphasis on environmental and process controls to ensure the safety of your therapy.
Customized services for manufacturing your therapy
Parenteral drug products, which include intravenous (IV), subcutaneous (SC), or intramuscular (IM) routes of administration, require careful planning, thoroughly trained personnel, and dedicated facilities to ensure patient safety. At our state-of-the-art facilities, we have the expertise to develop, pharmacy compound, manufacture, test, release, and supply a range of formulations (IV, SC, and IM administration) for a variety of clinical study types, including first-in-human (FIH) healthy volunteer studies assessing safety, tolerability, and pharmacokinetics (PK), as well as radiolabeled formulations for human absorption, distribution, metabolism, and excretion (ADME) studies. Utilize our services as a standalone offering or as part of an integrated drug development program tailored to meet your needs.
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Info SheetQuotient Sciences Aseptic Development & Manufacturing Capabilities Info SheetQuotient Sciences has expertise in developing, manufacturing, testing, releasing, and supplying a range of formulations (IV, SC, and IM administration) for a variety of clinical study types, including first-in-human (FIH) healthy volunteer studies assessing safety, tolerability, and pharmacokinetics (PK), as well as radiolabeled formulations for human absorption, distribution, metabolism, and excretion (ADME) studies.
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Info SheetTranslational Pharmaceutics® Fact SheetQuotient Sciences helps you achieve your goals by enabling precise formulation development, streamlined manufacturing, quick pivot to clinical data and a significantly faster transition through drug development.
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Case StudiesEndevica Case Study - Peptide Program using Translational PharmaceuticsEndevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Read how they leveraged the Quotient Sciences Translational Pharmaceutics platform for this program.
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Case StudiesEnsysce Biosciences Case StudyRequest a copy of our latest case study with Ensysce Biosciences about how our integrated strategies helped them achieve their regulatory milestones faster for PF614-MPAR, an Extended Release product.