Advanced Frameworks for Process and Analytical Technology Transfer

• Quality by Design (QbD): With our extensive process and product understanding, we apply the principles of QbD to ensure the highest possible outcomes for each product, reducing the risks during tech transfer.
• Our team as an extension of yours: Communication is key for successful tech transfers.
  • At Andelyn, we work as OneTeam™ with clients, regularly workshopping process flows, control strategies, and success criteria throughout the tech transfer process.
  • Direct discussions with our SMEs and MSAT group enable streamlined and beneficial interactions between scientists.
  • Our highly interactive transfer process includes hands-on demonstrations, shadowing, rigorous training, constant feedback loops, and a person-in-plant.

Supporting Clients through Analytical Comparability

A clear path for establishing comparability is needed to facilitate tech transfer processes, and the ability to successfully execute comparability exercises is critical. Comparability strategies are tailored to each program and product type; at Andelyn, we follow a stepwise approach, starting by identifying the product attributes to be assessed. We work collaboratively with our clients to draft the analytical comparability protocol and acceptance criteria based on program needs and execute the protocol, leveraging Andelyn's extensive analytical capabilities.

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Flexible Facility Design for Smooth Tech Transfers

• The Andelyn Development Center (ADC) is equipped with the same manufacturing equipment and analytical instruments as our Corporate Center. The ADC provides initial proof-of-concept, engineering, and training runs to enable a smooth transfer into GMP production.
• Our GMP vector facility, the Andelyn Corporate Center (ACC), was designed to enable easy reconfiguration to accommodate different processes and modalities. For example, all clean rooms have dedicated air handlers operating as standalone units, and each suite is large enough to accommodate up to 2,000L bioreactors. This flexible design reduces the need for extensive facility modifications during tech transfer, shortens tech transfer timelines, lowers costs, and enables our client's roadmap from preclinical to commercial.