CDMO Services for Biologics, Cell and Gene Therapy and Viral vectors

Bringing a biopharmaceutical programme from concept to clinic demands early decisions on cell line development, process design, and analytics. These decisions carry significant downstream consequences for quality, scalability, and regulatory acceptance. Biotech and pharma companies increasingly need a biologics CDMO that integrates scientific depth with manufacturing foresight from day one.

We offer end-to-end contract development and manufacturing across AAV, lentiviral and adenoviral vectors, monoclonal antibodies, recombinant proteins, and cell line development, covering everything from gene therapy to complex biologics. Our GMP facility in Berlin supports programmes from early process development through clinical-stage production, with full alignment to EMA and FDA requirements.

A key differentiator is our proprietary transposon-based cell line technology, a platform that consistently delivers stable cell lines expressing up to 24 g/L, with material from pools available in as little as 8 weeks after project start. With over 450 stable cell lines developed to date, our track record speaks for itself.

With over 30 years of biologics expertise, we bring the technical range and regulatory understanding your programme needs.

Explore our full CDMO service offering below.

AAV, Lenti & Poxvirus Production

Antibodies & Recombinant Proteins

Stable Cell Line Development

USP & DSP Process Development

DirectedLuck^®: Higher Titers, Faster to Clinic

Our DirectedLuck^® transposase system uses epigenetic targeting to integrate transgenes at genomic sites with the highest transcriptional activity — delivering titers up to 24 g/L and stability across pools and clones beyond 80 generations. Stable pools are available within days and are directly representative of later clones, enabling rapid TOX material supply without additional risk. For complex formats such as bispecifics, gene dosage can be precisely adjusted to maximise heterodimer rates and product purity.

One Partner, One Quality System, Zero Handover Risk

From AAV, lentiviral, and poxvirus vector production to monoclonal antibodies, bispecifics, and recombinant proteins, we cover the full biologics spectrum within a single quality system. One partner, one relationship, one point of accountability across contract development and manufacturing — from early cell line development through GMP manufacturing. This integration eliminates handover risk, compresses timelines, and means your CMC history stays intact across every project phase.

EU-Based GMP: Faster Submissions, Fewer Complications

Our Berlin facilities operate under GMP conditions with manufacturing licences issued by German health authorities, aligned with EMA and FDA requirements.
We provide cleanroom environments up to Grade B for protein manufacturing and up to Grade A for viral vector production, with bioreactor capacity of up to 1,000L for proteins and up to 200L for viral vectors. For sponsors pursuing European clinical trials, EU-based GMP manufacturing simplifies regulatory submissions and removes the complexity of cross-border technology transfer.

Proven Partnerships, Measurable Outcomes

Polpharma Biologics selected us to generate a high-yielding, stable production cell line for their biosimilar pipeline, leveraging CHO.RiGHT^® and DirectedLuck^® to meet critical quality attributes and accelerate timelines. At the commercial end of the spectrum, our GlymaxX^® technology contributed to Ziihera^® (zanidatamab-hrii), a bispecific antibody that received FDA approval for HER2-positive biliary tract cancer.

1.Discovery & Scoping

We begin with a structured conversation to understand your molecule, programme stage, and timeline requirements. Our project management team maps your needs against our contract development and manufacturing capabilities and defines a clear scope, deliverables, and indicative timeline — giving you a transparent basis before any commitment is made.

2. Feasibility Assessment

We asses the technical and regulatory feasibility of your programme in close collaboration with you — via teams call or email — identifying critical path activities and potential risks before development beigns. Because every programme is different, this step is tailored to your specific molecule and development stage rather than following a fixed format.

3. Development

Cell line development, upstream and downstream process development, and analytical method development run in an integrated, cross-departmental workflow. Our USP and DSP teams collaborate closely from the outset, minimising unwanted variants and maximising yield — with material from pools available in as little as 8 weeks

4. GMP Manufacturing

Your process transfers into our Berlin GMP facility for clinical-stage production. Our in-house QP oversees batch certification, and our quality system ensures full alignment with EMA and FDA requirements throughout. With approximately 28 GMP batches delivered per year, we have the capacity and track record to keep your programme on schedule.

5. Scale-up & Tech Transfer

We support both inbound and outbound technology transfer, managing the full transfer package: process documentation, analytical methods, media and feed licensing, on-site training, and ongoing troubleshooting support. Our project managers coordinate between all parties to ensure a reliable transition with minimal disruption to your timeline.

What does CDMO stand for?

What types of biologics does ProBioGen manufacture?

How long does a typical programme take from first contact to GMP batch?

Can ProBioGen handle both early-stage development and commercial manufacturing?

What is the difference between a CMO and a CDMO?

Is ProBioGen GMP certified?

Where is ProBioGen located and does that affect our regulatory pathway?

How do I get started — what does the first conversation look like?

Biologics CDMO Services in Berlin

End-to-End CDMO Services for Biologics, Viral Vectors, and Vaccines

Our CDMO Services