Cell & Gene
CDMO offering
PolTREG has one of Europe’s most advanced state-of-the-art facilities for manufacturing of cell and gene therapies.
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Our offer
We provide a comprehensive range of services, and technologies in the field of Cell & Gene therapy.
This includes development, manufacturing and testing services, as well as tools and solutions to support clients at every stage of the therapy development process – from obtaining funding to basic research to commercialization. Our aim is to help clients successfully develop, de-risk and industrialize their therapies.
Our unique selling points
01
Manufacturing expertise
for autologous TREG therapies gained from our proprietary development programs (around 200 batches of therapies manufactured so far over the last 17 years).
02
Process development and process optimization expertise
particularly in the TREG therapy manufacturing.
03
State-of-the-art manufacturing facility and equipment
(including fill-and-finish solutions) enabling cost-efficient manufacturing.
04
Free, available capacity
– expected large scale manufacturing facility to be completed in the second half of 2023 with throughput of up to 700 batches of therapies annually.
05
Emerging manufacturing capabilities in CAR-Ts in oncology
06
Viral vector manufacturing
We currently work with some external suppliers of viral vectors. However, in the foreseeable future we expect to be able to produce our own viral vectors, as well as large scale DNA production to the GMP standard.
07
Well-known brand in scientific community
regarding TREG therapies manufacturing, clinical trials and commercialization (through the hospital exemption program).
08
Potential to support prospective clients with obtaining non-dilutive, non-refundable public funding from various local institutions supporting local R&D and manufacturing projects
This may require for the client to establish a local subsidiary in Poland.
09
Potential to support prospective clients with discounted prices for the CDMO services in exchange for equity stakes
Furthermore, we could also support clients with making contacts with the local VC community to provide further funding support.
10
Potential to support prospective clients with the regulatory and clinical development activities in Poland to speed up the commercialization process
Our Facility
We are immensely proud to be constructing a modern, state-of-the art manufacturing facility, which we expect will be fully operational this year.
We believe this facility will be one of the most advanced in Europe for cell and gene therapy manufacturing. We expect to have 2100 sqm of laboratory space with 15 production lines. It will allow us to manufacture our own products at scale, and also to provide contract development and manufacturing operation (CDMO) services to third parties to GMP/cGMP standards. TREG based therapies and associated technology requires manufacturing proximity to treatment, so we consider this facility will be a useful resource for future partners selling into the European market.
2100 sqm
of laboratory space
15
production lines
700 batches
of therapies – expected maximum annual throughput
17 years
of experience in cell therapies
CDMO services
to GMP/cGMP standards
