Phase I

We understand the acquisition of Phase I clinical material is an important milestone in your candidate’s development. The quality burden for human use requires a significant investment of effort and we can manage your successful transition into the GMP environment.

Experienced professionals perform production batch record review on all processes, with client approval if desired. We offer strict control of raw material, intermediate and final API quality, and our systems ensure compliance and continuous improvement.

Analytical methods provided by clients can be transferred as needed, and this may take the form of a reduction to practice or a formal protocol-driven method transfer. Development activities focus on refining analytical methods, especially with respect to the API impurity profile. More extensive impurity identification is pursued using LC-MSn and isolation using targeted synthesis or preparative HPLC.

Both of our research and manufacturing facilities are equipped to handle potent molecules. We have the technology to perform catalytic process screening to optimize catalyst type and loading, as well as process parameters around the catalytic chemistry. Utilizing our separations technologies, we will isolate and identify low-level impurities for use as qualified reference standards, solidifying the quality of your NDA.

Our committed manufacturing teams enable you to realize the next milestone in your drug development cycle. Our kilo labs and pilot plant provide flexible options for the synthesis of your clinical API needs under GMP conditions, regardless of scale. In all cases, we offer you cost effective and efficient manufacturing while adhering to environmental and process safety best practices.