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.
 

A step-by-step approach to commercial readiness 

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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.
 

Complete the form below to setup a meeting.


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