At Biotech Week Boston, we sat down with Dr. Christopher Smalley, Senior Consultant at ValSource (formerly the Director of Global Technical Operations at Merck & Co.) for some exclusive insights into evaluating risk of components in aging facilities.
As the biopharmaceutical pipeline is becoming more complex, the industry is rethinking the traditional one product-one facility approach to manufacturing. This attempt to create flexible manufacturing facilities not only addresses the need for multiple products but also can accommodate market demand.
In this exclusive interview, Dr. Smalley addresses some of the major challenges and trends in the bioprocessing industry today;
- What sorts of components are introducing risks in aging facilities?
- Which risks are especially critical to address?
- Is upper management usually receptive to the need for upgrading equipment and related components?
- Do issues related to documentation of equipment impede a company’s willingness to upgrade processing equipment?
- What effect do these upgrades have on a company’s already marketed products?
- What procedures should a company have in place for regular evaluation of component robustness and appropriateness?