cGMP Clinical Research

With increasing requirements from Institutional Review Boards (IRBs) and regulatory agencies, partnering with  Cambridge Isotope Laboratories, Inc. (CIL) for your next stable isotope cGMP project can help support regulatory compliance and reliable supply.

CIL operates the world’s largest ¹³C and ¹⁸O isotope separation facilities, enabling access to high-quality starting materials for clinical research and development. In many cases, your compound of interest may already be available within CIL’s extensive portfolio. If not, CIL’s team of PhD chemists can evaluate the most suitable synthetic route for incorporating ¹³C, ¹⁵N, ²H (deuterium), ¹⁷O and/or ¹⁸O into your target molecule.

CIL has manufactured bulk active pharmaceutical ingredients (APIs) since 1994 and has expanded its capabilities with a 15,000 sq. ft. state-of-the-art cGMP facility, complementing its existing GMP manufacturing infrastructure.

At Goss Scientific, we have many years’ experience supporting customers on clinical projects from initial enquiry through to delivery. We help coordinate key elements of project planning, quality documentation, regulatory compliance and controlled delivery. Please contact us to discuss your upcoming project and how we can support you.

cGMP Manufacturing Capabilities

• Dedicated development facility

• Seven production suites

• Dedicated packaging room

• Production scale from grams to multi-kilograms

• Clinical trial supply through to bulk API

• Customisable projects to meet your requirements

Quality & Compliance

• Drug Master Files (DMFs)

• FDA-audited facility

• QA release of API product

• Follows FDA and ICH guidance

• CMC support for NDA and IND submissions

Analytical Services

• Fully equipped analytical facility

• Method development and validation

• Raw material and final product testing

• Wet chemistry and compendial methods

• Stability studies and stability chambers

• Dedicated cGMP instruments and facilities

Analytical instrumentation includes:

• High-field NMR (¹H, ²H, ¹³C, ¹⁵N and other multinuclear capabilities)

• HPLC with UV, RI, ELSD, DA, Pickering and MS detection

• GC with FID, ECD and MS detection

• Karl Fischer (KF)

• FT-IR

• Polarimetry

• TOC