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Things to Consider in Early Development for Late-Stage NCE Success- Part Three: Quality Systems

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Adapted by Richard Sidwell, Ph.D., Chief Scientific Officer, from a previously recorded panel discussion with Pharmaceutical Technology 

Societal’s Neha Shah, Director of Product Development, Shweta Sinkar, Senior Product Development and Manufacturing Scientist, and Eduardo Uribe, (former) Senior Director of Quality Assurance, sat down with Pharmaceutical Technology to discuss various things to consider in early development. We shared details of the process, key things to consider, and potential challenges in parts one and two. The final installment on quality systems and how Societal may be able to help you will round out the series.

How do you apply a quality system so as not to delay product development?

Quality systems are not here to hinder or arrest development. Some people seem to think of the quality system in early development as an annoying hurdle. However, quality systems track all the activity during development, document what has occurred, and ensure it’s been performed on equipment and instruments that have been properly qualified. This information aids in our clients’ regulatory submissions, which are then reviewed by the regulatory authorities. Quality systems aid our clients in their product development and help avoid any erroneous data, equipment train issues, or even quality by design, as there might be a missed design space.

How does a multi-phase quality system work for a CDMO whose work ranges from R&D to commercial?

What we call a multi-phase system means it covers all the developmental steps and phases during drug development. One quality system encompassing all phases may seem counterintuitive, as different phases have different requirements. However, consider that procedures, processes, equipment, and instruments may be shared across many projects, which can be in different phases of development. A multi-phase system starts with a single standard of quality that can easily be adjusted across projects and the facility. 

The critical question is how compliance can align with early-phase and late-phase projects. Simply put, this is aligned with the end-user documents and the test methods. Batch records are written per the project phase designation. Test methods commonly use ICH guidance for phase relevance. The batch records written are no different. The ranges and targets for the early phase are wider to allow for development. As that development matures into the late phase, the same ranges and targets are fine-tuned to monitor the manufacturing process and show how it is under control.

How can Societal help?

At Societal, we have access to a considerable network of expertise, both in-house and external. We are constantly in communication with a range of different API vendors and excipient manufacturers. The same applies to some tests that we may have to outsource, and we know what analytical labs to go to. Even in terms of other expertise like facilities or engineering, we have it all in-house, and we are always ready and prepared to deliver on any project challenges you may have. One of the important aspects of our team currently is that we have commissioned a new automatic aseptic fill-finish line here in San Diego, all in ISO class 5. We can fill and finish vials from 2 mL up to 50 mL. We can also lyophilize up to 10,000 vials per batch, depending on the vial size. 

We have been in this business for more than 20 years and have built a very strong and expansive technical history that is very helpful for us. In a nutshell, we can do it all. We have a very focused and energized team here at Societal to deliver solutions for any technical challenges you may have.

Working with an experienced CDMO like Societal that can handle the inevitable surprises can save time and cost and deliver these much-needed therapeutic drug products to patients on time. We are a bi-coastal CDMO with end-to-end capabilities that will help move the processes seamlessly from development through commercialization. This saves time and money by avoiding unnecessary knowledge and tech transfer. With Societal as your partner, you’ll also have access to in-house quality and regulatory experts to support the regulatory aspects early on in development throughout the lifecycle of the product.

Richard Sidwell, Ph.D.
Senior Vice President and Chief Scientific Officer
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