ProductLife Group / ProductLife France

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Further Collaborations ProBioGen AG

Herbert-Bayer-Str. 8 13086 Berlin Germany Dr Lutz Hilbrich (CEO) +49-30-322-935-100 +49-30-322-935-400 info@probiogen.de cmo@probiogen.de www.probiogen.de

I Q

240 1994 S1, S2

l Biopharmaceutical development and

GMP production facility l Biopharmaceutical contract development and manufacturing l Proprietary technologies for improving product characteristics and process efficiency

ProBioGen holds numerous international patents on technologies to improve product quality/potency and enhance cellular productivity.

With many international companies and research organisations, e.g. Boehringer Ingelheim, Bayer, CRISPR, Novartis, etc.

ProBioGen works with biotech and pharma companies that develop complex therapeutic glycoproteins or viral vaccines. Services include cell line and process development up to GMP manufacturing, using animal and human cell lines. In addition, proprietary product/process-improving technologies are out-licensed.

Intelligent biopharmaceutical solutions

Internationally renowned specialist for developing and manufacturing complex biopharmaceutical active ingredients with the aid of state-of-the-art services and innovative technologies, with manufacturing authorisation for human biopharmaceuticals according to FDA/EMA standards.

Experience & client feedback

For over 27 years we have been a successful development and manufacturing partner for leading biotechs and pharmas on novel products, biosimilars, e.g. mAbs, Fc-fusion proteins, clotting factors, and enzymes. Clients value our scientific expertise, excellent working relationships, and outstanding flexibility.

Unique services

Quality development services We offer true “one-stop-shop” complete service packages from early lead optimization, rapid and integrated development of high-producer cell lines, processes, and analytical methods, up to full GMP manufacturing programmes. Our comprehensive analytics portfolio includes IPCs, release tests, and in vitro bioactivity assays. Innovative technology platforms to optimise yields, boost product potency, increase development speed, and cut manufacturing costs; all independently available for licensing.

Integrated cell line and process development Our pharmaceutical cell line development with CHO.RiGHT® platform includes proprietary, royalty- and license-free expression vector technology, DirectedLuck™ transposase, CHO host cells, and our own chemically defined media platform. The excellent reputation of our cell line development skills is based on fine-tuned, individually tailored clone selection procedures and early integration of upstream and downstream selection parameters. This allows the selection of the optimal expression strategy for each protein and enables rapid and economic upstream process development.

Reliable and flexible contract manufacturing We offer GMP production in fully state-of-the art disposable systems in fed-batch and continuous processes in up to 1000L bioreactors, including:

Your Biologics. Elevated.®

› USP & DSP Development › Cell Banking (MCB/WCB) › GMP Manufacturing › Analytical Development

Cell-based activity assays A range of cell-based activity assays for potency and mode-of-action analyses is established or can be developed from scratch.

Innovative technologies

GlymaxX® ADCC enhancement Our glyco-engineering technology prevents cellular fucose synthesis and thus antibody fucosylation, for maximised ADCC cell-killing activity against tumour and infected cells. This works for novel and existing producer cell lines, your expression platform, and can be licensed independently.

Glyco-engineering Fucose, galactose, and sialic acid levels of glycoproteins can each be adjusted, e.g. in biosimilar projects.

DirectedLuckTM – Transposase for superior titers Our novel proprietary transposase for efficient gene delivery, homogenous clone pools, and high-titer clones (up to 8 g/L) cuts hands-on lab time and overall timelines; available for licensing.

Productivity-boosting pathway modulator An engineered Cdc42 enzyme for typically increased cellular productivity is applicable to existing cell lines and expression platforms; available for licensing.

AGE1.CR® viral vaccine manufacturing platform Duck cell line to replace CEFs for GMP-compliant viral vaccine production, incl. highly attenuated ones, e. g. MVA and viral vectors. Chemically defined media platform and scalable suspension processes for industrial production.

Human artificial lymph node – immunofunction testing Our fully human, mini bioreactor-3D matrix system for longterm testing of drugs for immune as well as immunogenicity function bridges the gap between animal studies and human clinical trials.