Integrating Research & Development (R&D) with Chemistry, Manufacturing, and Controls (CMC) is not just a best practice—it’s essential when scaling up advanced therapies. The success of therapies hinges on seamless collaboration between these critical functions from the outset, ensuring they are groundbreaking, manufacturable, scalable, and regulatory-compliant. However, despite progress in embracing advanced analytics, data science, digitalization, and automation, CMC processes often remain hindered by legacy systems, unstructured data, and siloed architectures. By fostering a close partnership between the CMC team and the R&D team, whether that R&D sits with the client or in AmplifyBio, we overcome these challenges and reduce the risks of costly delays or safety failures.
At AmplifyBio, the principle that “the product is the product” guides our entire development process. We consider this when looking for ways to align the R&D and CMC teams. In the partnership models offered by AmplifyBio, alignment from the initial discovery phase is encouraged to anticipate and address potential manufacturability challenges. This early collaboration ensures that product characterization is thorough and that the materials and processes used in R&D align with the stringent requirements of Good Manufacturing Practice (GMP) production, thereby minimizing the risk of costly delays or rework later in the development cycle.
We believe in a proactive strategy of ‘starting with the end in mind.’ By considering the final product’s manufacturing and regulatory requirements from the outset, our teams can design or collaborate on R&D processes that smoothly transition into scalable manufacturing protocols. This proactive approach not only streamlines development but also enhances the quality and consistency of our products.
Our New Product Introduction (NPI) program is a cornerstone of this integrated approach. This program begins with rigorous project planning and risk assessment, followed by tech transfer and engineering runs that consolidate processes and train operators. When a product reaches clinical manufacturing, it has undergone thorough testing to ensure the highest quality and safety standards.
Successful integration requires more than aligned processes—it demands a culture of open communication and collaboration. At AmplifyBio, our leadership actively promotes cross-functional teamwork, encouraging R&D and CMC teams to share insights, challenges, and solutions. This collaborative environment ensures that potential issues are identified and addressed early, reducing the likelihood of late-stage surprises derailing a project. Additionally, our investment in advanced data generation, protection, and shareability during process development ensures that decisions are rooted in the latest science, aligning innovation with practical manufacturability.
By combining modern technologies with a collaborative ethos, AmplifyBio ensures that therapies are not only groundbreaking but also manufacturable, scalable, and compliant with regulatory standards, meeting the demands of today’s advanced therapeutic landscape.
AmplifyBio CDMO Services
AmplifyBio QC and Analytics for Manufacturing