Frequently asked questions
At what stage can you take on a process development program?
Programs can start with us at early development or enter with an established process. Where development has already been performed elsewhere, we assess the available process and analytical information and define what is needed for optimization, characterization, scale-up, and transfer into cGMP manufacturing.
Which modalities do you support for process development?
Our process development capabilities span biologics, gene therapy, and cell therapy. This includes mammalian and microbial biologics, plasmid DNA and viral vectors, alongside dedicated process development capabilities for cell-based therapies.
Can you develop both upstream and downstream processes?
Yes. Our integrated USP and DSP capabilities allow upstream productivity, product quality, purification performance, recovery, robustness, and scalability to be considered together throughout development.
Can you optimize an existing process before cGMP manufacturing?
Yes. An incoming process does not need to be manufacturing-ready. Depending on program needs, we can optimize process parameters, media and feeding strategies, productivity, purification performance, recovery, robustness, and scalability before transfer into cGMP manufacturing.
What process development scales can you support?
Our development infrastructure spans high-throughput and small-scale systems through pilot-scale upstream runs up to 200 L, supporting process screening, optimization, characterization, scale-up, and preparation for cGMP manufacturing.
Do you support gene therapy process development?
Yes. We support plasmid DNA and viral vector process development, including upstream production, transfection optimization, downstream purification, analytics, process characterization, scale-up, and transfer into cGMP manufacturing.
Can you support cell therapy process development?
Yes. Our cell therapy platform combines process development, closed-system processing, adherent and suspension technologies, integrated analytics, digital process monitoring, and cGMP manufacturing infrastructure to support cell-based therapy programs from development through manufacturing transfer.
Do you support formulation and stability development?
Yes. We develop liquid and lyophilized formulations and integrate formulation screening, analytical characterization, and stability assessment with the broader development program.
Where are your process development capabilities located?
Our process development capabilities span Vilnius, Lithuania, and Waltham, Massachusetts, connecting development, analytical, and manufacturing expertise across biologics, gene therapy, and cell therapy programs.
