BioMARC’s Commitment

BioMARC is dedicated to assisting in every way possible to the fulfillment of your product manufacturing lifecycle milestones.  Furthermore, the goal of  BioMARC is to provide an opportunity for academic, government, and private sector researchers to engage in cutting-edge product development activities with a focus on infectious disease agents and we welcome all opportunities to work with you to move new products and processes forward.

Key features of BioMARC include:

• A well-integrated Business Development Unit that will build a plan for success.
• A strong Project Management Unit that will facilitate the efficient and uninterrupted progression of your project.
• An experienced in-house Quality Unit (QA and QC) to meet high quality and regulatory standards.
• A Manufacturing Unit that oversees multiple BSL-2/3 ISO-5/7/8 cGMP suites that will produce your product to cGMP standards, including validation.
• A dedicated Facilities Unit that will keep the entire cGMP environment (HVAC, Equipment, BMS, etc.) qualified and in compliance.
• A Process Development Unit (with BSL-3 development laboratories) to help transition your product into GMP and to develop both processes and methods (characterization, in-process and/or release) toward validation.
• FDA-inspection experienced staff that can facilitate Phase I and II product manufacturing.

You are encouraged to use this web site to explore our programs and people, and please do not hesitate to reach out to us.

Darragh G. Heaslip, PhD