Analysis Paralysis: Navigating Early-Phase Analytical Validation

Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and analytical validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.It is critical to establish a product/project’s…

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies

Microbial challenge studies are becoming increasingly common as drug products (DP) are being manufactured with different types of active pharmaceutical ingredients (API) than fifteen years ago (IND Submission). Peptides, proteins, monoclonal antibodies, oligonucleotides, and biosimilars are more common; manufacturing no longer places an emphasis on small molecules. These new APIs…

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.

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.

Amplify Pharmaceutical Supply Chain Visibility and Performance

In the highly regulated and precision-driven pharmaceutical and biotechnology industries, operational transparency, real-time data access, and agile project execution are not just value-adds, they are imperatives. Singota Solutions addresses these critical needs through its integrated support infrastructure, combining cutting-edge digital tools with personalized project oversight. This article explores the technical…

Posts pagination