AGC Biologics
Center;'>Success Story AGC Biologics

One of the biggest topics of discussion in the world of biopharmaceutical research and drug development today revolves around current Good Manufacturing Practice (cGMP) regulations. While adhering to the constantly changing and evolving guidelines established by authorities—namely the FDA and MDR—can be a challenge in and of itself, moving towards the commercialisation of medicines has several deep-rooted hurdles that need to be addressed with superior subject matter expertise. Many players have emerged over the years to help the industry best manage its manufacturing and regulatory responsibilities, but Washington-based AGC Biologics takes the cake.

AGC Biologics is a contract development and manufacturing organisation (CDMO) that offers the most comprehensive and compliance-driven quality assurance solutions. The company is perfectly positioned to help organisations that wish to commercialise their products navigate the landscape with ease. Its integrated quality management system and extensive regulatory track record proven over the years ensure that each product goes to market expeditiously, all while remaining 100 percent compliant. Moreover, AGC Biologics specialises in the manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), and viral vectors and genetically engineered cells. Upstream and downstream process development expertise for these particular areasis not an easy find, thus AGC Biologicsstands as a unique solutions provider in the space, supporting enterprises with unparalleled CDMO services that dedicatedly follow cGMP policies as well.

To best elaborate on the efficacies of its offerings, the following case study of how AGC Biologics helped a company develop and validate the manufacturing processes of two novel molecules serves as the perfect example. Through this engagement, AGC Biologics’ process validation expertise shines, where its Quality by Design (QbD) approach meets and exceeds the expectations of the client. The company strongly commits to fool proofing each manufacturing processso as to ensure desirable outcomes at each stage of production. QbD follows formalised methods and a quality system infrastructure that is designed to support scalable manufacturing for early- and late-phase clinical requirements all while satisfying the commercial demands of the client.

Of the two products in question, one was in its first phase of development while the other had already moved into its third. AGC Biologics, prioritising the mitigation of risks involved, carriedout a thorough assessment of the project and identified all the Critical Process Parameters (CPP) the client might face as early and quickly as possible. It well understands the shortcomings of executing a control strategy towards the later stages of development—both in terms of monetary and time-based repercussions.

The expert CDMO consequently empowered the client with the ability to take precautionary measures to their process development strategies before launching full-blown implementations. Approaching the pharmaceutical manufacturing lifecycle with QbD additionally circumvents several regulatory issues that would otherwise impede the client’s progress.

AGC Biologics orientedall of its operations and strategies in order to define and achieve the most desirable Critical Quality Attributes (CQA) to ensure a seamless product development journey for both molecules in their respective phases. Post its due diligence, the company architected effective initial process control strategies, leaving no stone in the process validation operation unturned. It is important to note that this entire process is built into AGC Biologics’ technical transfer quality systems.

The client was then able to orchestrate a manufacturing process that performs efficiently, maintaining high productivity and compliance levels across the facility. AGC Biologics additionally bolsters the operation by equipping the patron with a fully-customised continuous process verification program. The solution is designed to help researchers and supervisors better controlevery process at a granular level, where detailed key performance indicators express the smallest of changes in near real-time, allowing the client to act preemptively and best manage their manufacturing outcomes.

AGC Biologics has thus far successfully completed risk assessmentsfor the phase 1 product and is currently overseeing the same for the phase 3 project—the first of many rounds to follow. The findings borne from each assessment are constantly shared with the client in highly detailed reports, empowering them to make improved data-and objectives-based decisions as well. In doing so, AGC Biologics expects to help the client broaden their Scope of Work to newer, more nuanced areas of pharmaceutical manufacturing. The philosophy of acting first and fast is strong within AGC Biologics,and providing solutions and services built on the ethos has proven to improve go-to-market strategies, production times, and costs as well. The company has further showcased how the client can assess and avoid the many potential forthcoming risksin their product’s process development lifecycle.

AGC Biologics is confident in its expertise and capabilities and expects to execute the first iteration of a process control strategy for the phase 3 project by the end of the year. The company is also curating a portfolio of regulatory documents to help the client significantly minimise the time and cost for each project during their later stages of process development operations. AGC Biologics strives to deliver the most beneficial CDMO solutions to its clients, regardless of how challenging it may seem. The surety it offers is extremely reliable, and this case study is just one among many to complement its proficiency in this hypercompetitive marketplace.