Case Studies

Achieving Successful Tech Transfer for Late-Stage Biologics to FDA-Registered Facilities for Commercial Production

Common Pain Points in Tech Transfer

Advancing a product from late-stage development to commercial production in the biologics sector is a pivotal phase requiring extensive planning and precise execution. This transition is crucial not only for ensuring compliance with regulatory standards but also for maintaining product quality and operational efficiency. A secure tech transfer to an FDA-registered facility is essential for navigating these complexities successfully.

Bora Biologics leverages extensive experience and deep expertise to offer comprehensive solutions tailored to the unique challenges of a commercial launch.

Read the whitepaper to learn how Bora Biologics’ expertise and structured approach helps mitigate common challenges, facilitating a smooth transition from development to commercial production.

Tech Transfer for Late-Stage Biologics (PDF)

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Bora Biologics

the logical choice

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Client-Centric

100% commitment to supporting your success

We have been the client, bringing multiple biologics from IND to BLA. Your needs and goals are at the forefront of our approach. By involving you in every step of the process, we ensure transparency and alignment, reducing the likelihood of misunderstandings and ensuring the outcome meets your expectations.

Experience

14 years developing & manufacturing biologics

We have honed our ability to navigate complexities. Our track record from concept to commercialization means we can apply best practices and lessons learned, ensuring smoother project execution.

Expertise

125 seasoned scientists & regulatory professionals

Our team exudes deep knowledge and specialized skills. This expertise allows us to foresee potential challenges and implement proactive solutions, reducing the likelihood of setbacks.

Commercial-Ready

US FDA registered GMP manufacturing facility

We focus on delivering solutions that are ready for market. With clinical to commercial scale facilities consistently meeting compliance standards, we ensure your project is primed for success, minimizing the risk of costly revisions or delays.

Allied

access to global CDMO resources

Our partnership with Bora Pharmaceuticals provides additional resources and insights. This network enables us to leverage shared knowledge and expertise, further mitigating risks and accelerating the overall success of your project.