Case Study 1: M&A - A private equity company needed technical support in performing due diligence on a small molecule CDMO. A complete evaluation of technical capabilities, quality unit, environmental history, human resources, facilities including R&D labs, pilot facility and numerous other functions was completed allowing the PE company to make an informed decision on a potential acquisition.

Case Study 2: Manufacturing Troubleshooting: A company formulating a commercial product containing an API derived from microbial fermentation encountered stability issues that necessitated a recall of the product. A complete evaluation of the factors leading to instability included a site visit of the API manufacturer and formulator where the processes were thoroughly evaluated. The analysis allowed for identification of the process parameters leading to instability thereby allowing the manufacturer to recommence manufacturing with a more stable process and avoid future recalls.

Case Study 3: Biocatalysis – A small-molecule CDMO wished to evaluate enabling the company to perform biocatalysis thereby enhancing their service offerings. A complete evaluation of all aspects related to development (including bioengineering), manufacture and application to the synthesis of innovative products and generics included R&D staffing, laboratories, equipment (lab and pilot), analytical instrumentation evaluation was conducted. Capital requirements for bioreactors and purification equipment was done. Financial considerations such as market dynamics and ROI were considered. After this thorough analysis which included meeting with members of the Board of Directors, the company was able to make an informed decision on the investment.

Case Study 4: Synthetic Route Development – A small biopharmaceutical company with an early-phase clinical candidate had developed a medicinal chemistry route for a complex, small-molecule API and needed to prepare the clinical candidate for scale-up with an economical and robust process. Using innovative thinking coupled with extensive knowledge of process development led to an improved process with fewer steps, higher productivity, environmentally friendly and safe process. In addition, studies related to solid state properties necessitated engaging a company capable of polymorph and salt form evaluation affording a stable drug substance. Early phase work moved to pilot studies and ultimately successful validation.