Which Testing Does An Effective Certificate Of Analysis Include?

Source: Singota Solutions By Ken Chomistek, Singota Solutions Compendial monograph (pharmacopeial) testing applied to pharmaceutical raw materials and finished drug products is a critical element of drug development. A testing record is created in the form of a Certificate of Analysis (CoA) for manufacturing release and distribution. However, the testing required…

Establishing a Successful Supply Chain for High Value Products

Establishing a Successful Supply Chain for High Value Products Two of the greatest risks in high value BioPharma supply chains are the product adulteration during transport and non-compliance with regulations, guidelines and standards. After that, an important concern of manufacturers and distributors is cost containment in an increasingly globalized and…

Establishing a Remote Audit Process as a CDMO

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.

Strategies to Maximize Batch Yields in Aseptic Manufacturing: High Value Actives

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:

Analytical Instrumentation – Advancing and Maintaining CDMO Capabilities

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.