Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

Issue link:

Contents of this Issue


Page 25 of 75

26 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Process Development T he acquisition (or license) of a product, technology, or company can be one of the most crucial activities for any pharmaceutical or biotech company. The due dili- gence of the chemistry, manufacturing, and controls (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 significant 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 exercise. Thus, the due diligence assessment of the CMC area must be done in an ef- ficient 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 exer- cises for more than three decades. This experience includes being on the acquisition side for several 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 uncommon. In the first quarter of 2020, the FDA's Center for Drug Evaluation and Research (CDER) issued 300 Form 483s related to drug quality (5). The more dreaded CDER warning letter was issued to 15 firms in the same quarter for manufacturing-related issues (6). If either a Form 483 or warning letter is issued on a product/facility related to an acquisition, the likelihood of a delay and loss of deal value is likely. William J. Lambert, PhD, is principal, Module 3 Pharmaceutical Consulting, Incline Village, NV. TASHATUVANGO - STOCK.ADOBE.COM Due Diligence Assessment of CMC Activities William J. Lambert Developing comprehensive chemistry, manufacturing, and controls (CMC) programs are crucial to the success of a drug product. For planned acquisitions or licensing, a careful analysis of these critical factors is vital to ensure no problem areas are overlooked.

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - October 2020 - PharmTech - Regulatory Sourcebook - October