The effects of the pandemic have been far reaching within the pharmaceutical industry and compliance audits have not been immune. Widespread travel restrictions and adjusted visitor policies have prevented standard onsite audits from occurring. As a CDMO, Singota had to pivot to provide clients with transparent and robust compliance audits. This article will dive into the process of establishing a remote audit process and how Singota implemented various changes to acclimate to the new norm.
Advances in drug and biologics discovery have allowed the development of increasingly sophisticated and highly targeted therapeutics. The active ingredients, whether small molecules or biologics, have become increasingly complex and costly to manufacture. Because of the physical properties of most biologics, the route of administration is typically parenteral and therefore it is imperative that manufacturers of sterile drug product develop strategies to maximize their yields and minimize losses throughout the finished product production process. Here are a number of considerations:
CDMOs in the pharma industry rely heavily on state-of-the-art instrumentation to bring their client’s products from drug development through drug manufacturing to the patient. To better serve their client’s needs as technology and the industry advances, a CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation.
In part 1 of a 2 part blog series, we will explore some of the critical factors to consider when beginning work with these types of formulations.