• All
  • Best Practices
  • Industry
  • Innovation
  • Manufacturing
  • Testing
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 a CDMO’s 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.

The Dating Game – Trust & Compatibility in Outsourcing Partnerships

The journey through the clinical trial pipeline is hardly ever direct. Obstacles will present themselves that may or may not have been anticipated. By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.

Approach to Simplifying Aseptic Contract Manufacturing – Part 2: Documentation

In part two of the series, we focus on the impacts of the SA25’s operating principles, which combine to radically reduce and simplify manufacturing documentation. As we all know, the documentation requirements for cGMP manufacturing are extensive. Despite advances in automation and digital technology, the pharma industry has continued to rely heavily on legacy paper-based systems. Singota’s choice of the Vanrx SA25 Aseptic Filling Workcell was in part based on the way this system facilitates both the simplification and reduction in volume of batch documentation.

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:

The Advantages of a Cross-Functional Staff Model in Pharmaceutical Manufacturing

As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.