BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL

Their core work

The Paul-Ehrlich-Institut (PEI) is Germany's federal authority responsible for the approval and regulation of vaccines, blood products, and advanced therapy medicinal products (ATMPs) including gene and cell therapies. In H2020 projects, PEI contributes regulatory science expertise — ensuring that new therapies meet safety, quality, and efficacy standards before reaching patients. They provide nonclinical safety assessment, GMP compliance guidance, and regulatory frameworks for emerging biologics such as CAR-T cell therapies and genome editing. Their involvement in a project signals that regulatory readiness is being built into the development pipeline from the start.

What they specialise in

How they've shifted over time

PEI's early H2020 involvement (2015–2018) centered on cell and gene therapy manufacturing — CAR-T cell production, GMP compliance, and vaccine batch testing. From 2019 onward, their focus broadened significantly into clinical trial methodology (platform trials, Bayesian statistics), antimicrobial drug development, nonclinical safety modeling with computational tools, and public engagement around advanced therapies. The shift reflects a move from hands-on manufacturing regulation toward systemic challenges: how to design better trials, how to replace animal models, and how to govern therapeutic data responsibly.

PEI is expanding from product-level regulation into methodology — computational safety models, adaptive trial platforms, and data governance — making them increasingly relevant for projects that need regulatory innovation, not just compliance.

How they like to work

PEI participates exclusively as a consortium partner, never as coordinator — consistent with their role as a regulatory authority contributing specialized oversight rather than driving research agendas. They work in large consortia (266 unique partners across 15 projects) and do not concentrate on repeat partnerships, suggesting they are sought out as a trusted regulatory voice across diverse research communities. For consortium builders, PEI brings credibility and regulatory grounding without competing for scientific leadership.

PEI has collaborated with 266 unique partners across 32 countries, reflecting a deeply pan-European network spanning academia, pharma, and public health agencies. Their reach extends well beyond the EU into associated countries, consistent with the global nature of vaccine and therapy regulation.

What sets them apart

PEI is not a university lab or a contract research organization — it is the German federal regulatory authority for biologics, which gives it a uniquely authoritative perspective on what therapies will actually pass muster. Partners gain direct insight into regulatory expectations during development rather than discovering compliance gaps at the approval stage. Few organizations in Europe can provide this combination of scientific depth and regulatory mandate in advanced therapies and vaccines.

Highlights from their portfolio

• COMBINE
  Largest single EC contribution (EUR 1.47M) and longest timeline (2019–2027), addressing the critical challenge of multidrug-resistant bacterial infections from discovery through clinical trials.
• T2EVOLVE
  Directly tackles the regulatory and access barriers for CAR/TCR-engineered T cell therapies — a signature domain where PEI's regulatory authority is most impactful.
• imSAVAR
  Represents PEI's methodological frontier: replacing animal safety testing with micro-physiological systems and computational immunology for immune-modulating therapies.