Contract Manufacturing

Enteris BioPharma partners with clients to provide contract manufacturing services for solid oral dosage forms up to phase 3 and commercial scale. With a state-of-the-art 32,000 square foot facility and the capabilities to handle and contain highly potent APIs (HPAPIs), Enteris is well-equipped to ensure optimal manufacturing of your clinical and commercial supplies.

Enteris has historically utilized its vast CMC capabilities and expertise to build long-term partnerships with Peptelligence® and ProPerma® clients, from developing the formulation and analytical methods to cGMP manufacturing of clinical trial supplies. With a recent facility expansion, Enteris now offers cGMP manufacturing from early clinical trials up to phase 3 and commercial for solid oral dosage forms that either utilize Enteris’ technology or your own formulation technology and is equipped with an extensive analytical R&D lab to ensure full compliance and the highest quality.

The Enteris manufacturing group has considerable expertise in:

  • Immediate- and modified-release solid oral dosage forms
  • Highly Potent API (HPAPI) handling and containment
  • Analytical method development, verification, qualification, and validation
  • Process development
  • Process scale-up
  • Process validation
  • Technology transfer
  • Regulatory filing support