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Approach to Simplifying Aseptic Contract Manufacturing

Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. Many factors can conspire to make a rapid response to such an urgent supply situation challenging. This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed.

Raw Material Testing – Captisol

For the previous blog in this series, raw material testing programs were outlined, and common considerations for Contract Development and Manufacturing Organizations (CDMO) were discussed. In this section, the focus will be a specific example and highlight some of the thought processes behind raw material program development. Captisol®, a common formulation excipient for injectables, will serve as said example.

Developing a Raw Material Testing Program as a CDMO

Anyone with experience in the pharmaceutical industry knows that the APIs in drug products are tested rigorously for safety and efficacy before reaching the market. Before any raw material can be used for manufacturing, it must meet the requirements outlined in CFR chapter 211.84. Even minor issues with the API or a raw material could compromise the product’s integrity, leading to patient harm or expensive corrective actions such as recalls. Companies that perform drug product manufacturing and raw material testing take this responsibility seriously.

Microbiology Fulfills a Vital QC Role at a CDMO in Aseptic Filling and Sampling

When a pharmaceutical company is looking to outsource manufacturing and other services, in the background, the fundamental requirement is that the CDMO maintains an operating environment sufficiently controlled to formulate, manufacture, test, package, store, and ship products that will be for human use. Microbiologists play a vital role in ensuring conditions are optimal for the variety of pharmaceuticals that come into a CDMO.

5 Keys to Managing Information Technology in an FDA Regulated Industry

An IT career in the Life Sciences industry requires knowledge of regulatory requirements as well as having stringent controls and processes in place to ensure GxP requirements are met or exceeded. Here are some important items to address when managing information technology in an FDA regulated industry:

5 Takeaways from Preparing to Comply with the GDPR as a CDMO

What is GDPR? As a US based, small company, an EU law took some time to hear about. But once we did, we knew we needed to work on being compliant. Here are some lessons learned: