Product characterization is a highly complex cornerstone to the development of scalable cGMP manufacturing processes for cell and gene therapies. It requires modelling all of the mechanisms of action associated with the product, identifying the Critical Quality Attributes (CQA) of the product in relationship with the Critical Materials Attributes (CMA) and Critical Process Parameters (CPP). In some cases, this is critical to manufacturing high quality product and meeting safety and therapeutic efficacy requirements.
As the FDA points out, “there is no single test that can adequately measure those product attributes that predict clinical efficacy. Manufacturers demonstrate clinical effectiveness by “substantial evidence,” i.e., evidence that the product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof” (section 505(d) of the FDC Act).

The current standard is to go through a full analytical development lifecycle for each therapy

Assays can become the bottleneck in development process

Typically taking 5 to 9 months to complete creating Roadblocks for Subsequent Phases.

We offer two main strategies for your bioassays development for a successful product characterization towards GMP manufacturing:



A. Best-in-class full package assay development services

We combine client-specific project management with rapid and flexible turnaround-time to cover full analytical methods lifecycle (including development, optimization, qualification and validation of tailored assays) in an expedited manner towards IND filing, first-in-human or later phase trials. Our Assay development and product characterization team will start assay development activities concurrently with process development and optimization activities to optimize your timelines. 

Focus on critical quality attributes (CQAs) We are laser-focused on establishing appropriate and necessary CQAs to demonstrate Safety, Identity, Strength, Purity and overall Quality of your product. The analytical methods used in GMP manufacturing processes need to be robust and reliable and implemented into the manufacturing process prior to start of tech transfer to GMP suites.

Ensuring a smooth transfer of analytical methods into GMP manufacturing Our Bioassays team is responsible for training Quality Control and transferring the qualified and validated assays into the QC laboratory, where we ensure that the product can be manufactured reproducibly, robustly, in high-quality, respecting CQAs and meets our customer’s target product profile. We leverage our decades of experience across CGT modalities to fully characterize your product towards commercialization.

Analytical methods development

 


 

B. Established, pre-developed and fast-qualified assays for your therapy


Significantly reduce your timelines with our pre-developed and ready to fast-quality assays for your therapy.

By leveraging years of experience developing, optimizing, qualifying and validating assays across CGT modalities, we have built a proprietary library of pre-developed, fast-to-qualify assays for a range of modalities including iPSC therapies, immunotherapies (CAR-Ts), cell therapies and viral vectors. Our library of fast-qualified assays for cell & gene therapies include safety, identity, strength, purity and overall quality of the product. Following an evaluation of your process, our team recommends a suite of assays from our library of established pre-developed assays, based on your therapy, if applicable.

Assay families covered*

 

 

You could significantly reduce assay development time and get into Phase I trials in an expedited manner (IND, first in human). Each step of the assay development process is faster, with training of the QC laboratory taking much less time as our teams are already trained on this library of pre-developed assays. These assays have been qualified using typical matrices and representative products. We perform confirmatory experiments and limited matrix qualification to ensure your product and matrix are compatible with the Platform Methods. This in turn ensures that the assays used to test your product are compliant with GMP regulations.

 

Fill out the contact form to speak to our dedicated assay development team.


Watch our presentation at the Gene Therapy Analytical Development Summit introducing our library of pre-developed assays


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.

Careers in cell & gene therapy at Lonza


We are looking for candidates to join our team across our global network of sites.

View opportunities

cell and gene therapies


process development centers of excellence

Houston, TX, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Viral Vector Manufacturing

14905 Kirby Dr
Houston, TX 77047
United States of America

Geleen, The Netherlands

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Process Development, Analytical Development

Urmonderbaan 20B
Geleen
Netherlands