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

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies Source: Singota Solutions By Ken Chomistek, Singota Solutions 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. Peptides, proteins, monoclonal antibodies, oligonucleotides,…

Expertise And Efficiency In Small-Volume Batch Manufacturing

Expertise And Efficiency In Small-Volume Batch Manufacturing Source: Singota Solutions By Alex Cravens, Singota Solutions Demand for small-batch drug product (DP) manufacturing — from formulation to sterile fill/finish — is rising as drugs for precision medicine and large-molecule biologics gain in prominence. However, traditional fill/finish providers may consider small batch sizes…

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…

Systematic Approach to Early Phase Sterile Drug Product Technology Transfer

How should a manufacturer go about preparing for the initial transfer of a lab-scale process to the manufacturing plant? Experience demonstrates that while it would be convenient to simply apply a scale factor to formulation ingredients and prepare a manufacturing batch record on this basis, this is rarely the case. More often than not, there are factors that a tech transfer team must carefully evaluate and, where necessary, take measures to overcome potential problems in order to avoid a failure in the manufacturing setting.

Challenges and Solutions in Biologics Finished Product Manufacturing

Most biologics require a parenteral route of administration. Formulators therefore must develop a suitable means to deliver the product via injection, which entails addressing a variety of potentially complex challenges related to the unique properties of the biologic substance being delivered. Issues such as the stability of the biologic material in a solution state must be considered along with the overall practicality of a formulation in terms of manufacturing, storage, transport, and administration. While it may be possible to develop a formulation that meets the desired finished product characteristics using laboratory techniques, it is imperative that each formulation is carefully evaluated to confirm it is practical for industrial-scale manufacture. Here we will review those challenges and possible solutions:

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 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.

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