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:
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:
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.
Characterizing Novel Microparticle-Encapsulated Drug Formulations
In the previous blog post, we addressed the challenge of successfully formulating such compounds for oral administration. However, once you have successfully encapsulated an API, the next task is to characterize that product and understand its release kinetics.
Real-Time Monitoring
We can utilize technology to track the status of online purchases or the current location of our vehicles, smartphones, and even friends and family members. It would make sense then that we would want to take advantage of these same types of technologies as it pertains to the risk mitigation of our sensitive and high value pharmaceutical shipments.
Adaptive Clinical Trials and New Solutions
Among the key sources of delay in the development process is the length of the clinical trial process. In recent years, the FDA has allowed some pharmaceutical companies to mitigate these risks, and costs, by approving testing through what are called “Adaptive Clinical Trials.”