Process Development

Need help with Process Development?

High-risk gaps in the manufacturing process of cell and gene therapies are often under-estimated by organizations, resulting in major setbacks in the transition from a clinical-stage to a commercial therapy. We want to be your partner in this process, because driving pioneering therapies to market is what we thrive on.

Our highly experienced teams of experts are fully-equipped to identify and address your production challenges early, so you're not caught out when you need to scale up or out, and meet accelerated timelines for delivery.

We’ll work with you side by side to navigate the ever-changing regulatory landscape, while keeping your manufacturing costs under control.

With our highly tailored, step-by-step approach to commercial readiness, you can be sure of a robust, reproducible and commercially viable Good Manufacturing Practice (GMP) process, de-risking your path to successful commercialization.

True partnership

Most of our customers in cell and gene therapy are either small biotechs or started their journey as such and we know they face increasing unpredictability and competitive pressure. We will work together with you to formulate an innovative response to your unique situation and product. And we won't stop there. While keeping your manufacturing costs under control, we'll follow a continuous improvement approach as your therapy progresses through the journey to commercialization and your priorities evolve.

Our team aspires to become an extension of your team. We'll work side by side with you relentlessy to achieve your next milestone, while keeping your end-goal in mind. We'll run collaborative workshops, send our experts to your sites and host your experts on our sites to enable you to make the right, educated decisions on your process and manufacturing, at the right time.

Our un-matched experience working with regulatory bodies will help you to navigate the ever-changing regulatory landscape. We have dedicated cell-and-gene-therapy regulatory consultants here to support you, at each key step of the way.

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A step-by-step approach to commercial readiness

Diagnose to de-risk

Develop & industrialize

Deliver to GMP

Establish the baseline process and identify the major manufacturability gaps of the process and come up with the scope of development activities

Process optimization and development based on the manufacturing design specifications and critical quality attributes

Transferring the manufacturing process into GMP suite starting with pilot and training runs

We count on some of the best bioprocessing practices incorporated in the early development stage. We have implemented a defined model to ensure successful manufacturability and a clear path to clinical/commercial based on a 3-step approach for introducing new projects. It starts by diagnosing to de-risk to establish the baseline process, identify the major manufacturability gaps and come up with the scope of development activities; we then develop and industrialize the process, where phase appropriate process optimization and development based on manufacturing design specifications and critical quality attributes is performed; and then we deliver to GMP with a clear focus on transferring the manufacturing process into our cell therapy suites to start GMP manufacturing.

This 3-step approach is designed to enable our clients to efficiently reach their next milestone without compromising on the future requirements for a commercially viable process. Our aim is to deliver suitable materials on time, while simultaneously focusing on building the necessary maturity into the process required for the future. This approach balances the need for speed at the early stages with the robustness and reproducibility demands of future commercial manufacturing, thereby avoiding costly manufacturing failures and providing reliable clinical and commercial supply.

Diagnose to de-risk

Develop & industrialize

Deliver to GMP

Why choose us?

Access to a distinguished partner with deep heritage in biologics manufacturing and 20+ years of cell and gene therapy GMP expertise
Over 140 dedicated cell and gene technical experts
State-of-the-art facilities across 3 continents: USA, Europe and Asia
Holistic development strategy with the end in mind
Experience with various scale-up/out methods, platforms, tools and technologies
Integrated development and manufacturing capabilities from one company, under one quality system
Flexibility to address needs of small or large companies
Regulatory support from pre-IND all the way to commercialization

Our experts are ready to start planning your therapy's commercial readiness.

cell and gene therapies