Formatech, Inc. Information

At Formatech, we help make new drugs happen… at the speed of science! Formatech, founded in 1993, provides contract services that deliver unique solutions to our clients’ product development and manufacturing challenges. Our service offerings include: preformulation and formulation development of all common dosage forms, lyophilization development, cell culture/fermentation process development, purification/downstream process development and aseptic fill and finish of liquid and lyophilized dosage units. We have had excellent results developing biotherapeutic products. Our accomplishments include developing many Ab formulations at concentrations in excess of 200 mg/mL and an orally bioavailable peptide formulation. Our aseptic manufacturing facility produces liquid and lyophilized dosage units for clinical supplies or small-scale commercial products. Manufacturing support services include compounding/formulation, diafiltration/concentration (UF/DF), release testing, and ICH conforming stability programs. Our team is accomplished at completing new projects successfully even when confronted with very aggressive timelines. Our regulatory history includes FDA inspections and three inspections by the MHRA (letters and certificate of GMP compliance received).