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42 BioPharm International eBook October 2020 www.biopharminternational.com Due Diligence Assessment of CMC Activities For planned acquisitions or licensing, careful analysis of CMC factors ensures no problem areas are overlooked. T he acquisition (or license) of a product, technology, or company can be one of the most crucial activities for any pharmaceu- tical or biotech company. The due diligence of the chemistry, manufacturing, and con- trols (CMC) activities related to the acquisition are an important part of this process. The key CMC areas that should be covered are shown in Figure 1. Delays due to CMC issues can result in a signif- icant loss of value for the deal. To make matters worse, the proprietary nature of the CMC area often requires that the due diligence exercise for CMC activities occur near the end of the acquisition exer- cise. Thus, the due diligence assessment of the CMC area must be done in an efficient manner. Table I provides a comprehensive list of critical CMC items that should be closely watched. This list is based on relevant literature (1–4), as well as the author's experience of performing due diligence exercises for more than three decades. This experi- ence includes being on the acquisition side for sev- eral large pharma companies, as well being on the acquiree side and seeing the approaches used by a variety of other companies. Unfortunately, CMC issues are not that uncom- mon. In the first quarter of 2020, the FDA's Center for Dr ug Evaluation and Research (CDER) issued 30 0 For m 483s related to d r ug qua l it y (5). T he more dreaded CDER warning letter was issued to 15 firms in the same quarter for manufacturing-re- lated issues (6). If either a Form 483 or warning let- tashatuvango - Stock.adobe.com WILLIAM J. LAMBERT, PhD, is principal, Module 3 Pharmaceutical Consulting, Incline Village, NV 89450. WILLIAM J. LAMBERT Regulatory Sourcebook Process Development