Expertise in High Quality Manufacturing
Our team has many years of experience and in-depth knowledge of formulating and manufacturing culture mediums and ancillary products as Class III & II medical devices in the human Assisted Reproduction (ART) area under the strictest of global regulatory guidelines ISO6485, MHRA, EMA, FDA.
Our experience and expertise in high quality manufacturing has resulted in a track record of success and has demonstrated our team’s ability to repeatedly execute complex manufacturing and logistics of personalized and highly regulated biologics products with high batch to batch consistency and performance.
Our goal is to leverage our leading expertise from the highly regulated field of human ART culture media development & manufacturing into the cell & gene therapy, regenerative medicine, biobanking and drug discovery markets.
Quality Focus
Research and clinical success is highly dependent on the quality of cell culture, bio- preservation and storage media products and protocols.
Our team has a long track record of success in providing high-quality, pharmaceutical level products and services. We maintain this commitment to quality through:
- Dedication to upholding the highest regulatory standards for each step of the CGMP manufacturing process.
- Stringent quality control of every aspect of manufacturing
- Optimized formulations with pharmaceutical grade ingredients
Flexible and Reliable Service
The cell & gene therapy CMO and CDMO industry is becoming highly consolidated between large players. Concurrently, the C&G therapy, regenerative medicine, drug discovery and cell banking industries are growing rapidly and diversifying as the increasing number of new startups and IPOs in these varying spaces intensify. In addition, the regulatory requirements for high quality and cGMP compliant biosolutions are increasing. This means that time and batch flexible, cGMP compliant CMOs will be critically important to serving this rapidly growing and fragmented market
