Regulatory compliance associated with manufacturing is a distinct area of our experience.  We have assisted a number of clients in recognizing and addressing manufacturing cGMP/QSR issues.  We also participate in the planning, preparation and agency review of comparability protocols for manufacturing changes.

For organizations planning their first clinical or commercial product, we may be of assistance in the challenging conversion of research and/or laboratory scale processes into commercially feasible manufacturing processes.  During scale-up, there are often a number of possible development directions to attain the quantities of product required for the next pre-clinical or clinical phase.  However, it is critical to choose the technology and process direction that will be most comparable with the future commercial process.  We are able to assist companies and academic organizations plan their technology and production advances to be most suitable both for efficient production and for regulatory compliance.

Patient-specific products present particular challenges for "scale-up" or in most cases "scale-out."  Many production processes are workable at a level sufficient to treat from ten to 30 patients during initial clinical development but may not be feasible for the numbers of patients required in Phase 3 or for commercial operation.  We have experience in the detailed analysis and modeling of production processes to determine which methods may be most suitable for both clinical and commercial operations.  In addition these products are often very labor and facility intensive, requiring extensive planning to be successful.  FDA issues and concerns related to mix-up and to microbial contamination or contamination with adventitious viral agents necessitate specific aseptic processing controls.

We also provide "trouble-shooting" and problem solving services for existing manufacturing programs.  It is often very helpful to have an outside specialist review a production program for discovery of inefficiencies, problems or potential problems.  Contamination or cell viability problems are common instances where our extensive experience has been helpful in resolving production issues.