Biorapid · Project

Faster Drug Manufacturing: Cutting Bioprocess Development Time for Pharma Companies

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Getting a new drug from the lab to the pharmacy shelf takes forever — partly because figuring out how to actually manufacture it at scale is painfully slow. Biorapid trained 15 researchers in smarter ways to develop and monitor the biological processes that produce medicines, especially cancer and diabetes drugs. Think of it like teaching chefs not just recipes, but how to quickly scale a dish from a home kitchen to a restaurant chain without losing quality. They combined design-of-experiments methods with real-time monitoring tools so pharma companies can nail down their manufacturing processes much faster.

By the numbers

Early-stage researchers trained in rapid bioprocess development

Partners in the consortium

Countries represented (DE, DK, SE, UK)

Industry partners in the consortium

44%

Industry participation ratio

Total project deliverables produced

The business problem

What needed solving

Developing manufacturing processes for new biologic drugs — especially cancer and diabetes treatments — takes too long, delaying patient access and increasing costs. European biopharma companies also struggle to find personnel trained in modern process development methods like Quality by Design and real-time analytics. This combination of slow processes and skills gaps directly hurts competitiveness against global rivals.

The solution

What was built

The project produced 24 deliverables including Design of Experiments (DoE) and optimal design methods validated on an industrial case study. It trained 15 researchers in rapid bioprocess development spanning from early potency testing through to manufacturing-scale process characterization and monitoring, with methods applicable to oncology proteins, diabetes treatments, and other bioactives.

Audience

Who needs this

Biopharma companies developing oncology or diabetes biologicsContract development and manufacturing organizations (CDMOs)PAT and bioprocess monitoring equipment vendorsBiosimilar manufacturers seeking faster process developmentPharmaceutical companies transitioning to Quality by Design compliance

Business applications

Who can put this to work

Biopharmaceutical Manufacturing

enterprise

Target: Mid-to-large biopharma companies producing recombinant proteins or biosimilars

If you are a biopharma manufacturer struggling with long development cycles for new biologic drugs — this project developed rapid bioprocess development methods validated on industrial case studies that can shorten the time from lab-scale to manufacturing-scale. With 4 industry partners involved in development, the methods were designed with real production constraints in mind. The focus on oncology proteins and diabetes treatments means direct applicability to high-demand therapeutic areas.

Contract Development and Manufacturing (CDMO)

mid-size

Target: CDMOs offering process development services to pharma clients

If you are a contract manufacturer competing on turnaround time for bioprocess development — this project created Design of Experiments (DoE) and optimal design methods validated on industrial case studies. Faster process characterization means you can take on more clients and deliver results sooner. The 9-partner consortium across 4 countries built methods applicable beyond just the oncology and diabetes proteins they tested on.

Process Analytical Technology (PAT) Solutions

SME

Target: Companies developing monitoring and analytics tools for bioprocessing

If you are a PAT solutions provider looking to expand your toolkit — this project developed monitoring and modelling methods for bioactive molecule production, validated across a range of relevant bioactives. The methods connect early-stage potency testing all the way through to manufacturing process characterization. With 4 academic and 4 industry partners collaborating, the tools bridge the gap between research-grade and production-grade monitoring.

Frequently asked

Quick answers

What would it cost to access or license these bioprocess methods?

Biorapid was a Marie Curie training network (MSCA-ITN-ETN), so the primary outputs are trained researchers and published methods rather than a commercial product. Licensing terms would need to be discussed directly with the University of Newcastle upon Tyne as coordinator. Many methods from such training networks become available through academic publications.

Can these methods work at industrial manufacturing scale?

The project specifically included a deliverable on 'DoE and optimal design validated on industrial case study,' indicating the methods were tested beyond lab conditions. With 4 industry partners in the consortium (44% industry ratio), the methods were developed with real-world manufacturing constraints. However, full-scale deployment would likely require adaptation to your specific production setup.

What is the IP situation — can we use these methods freely?

As an EU-funded MSCA training network, much of the research output is published openly. However, specific tools or software developed with industry partners may have separate IP arrangements. Contact the coordinator at the University of Newcastle upon Tyne to clarify which outputs are freely available and which may require licensing.

How does this fit with current regulatory expectations like Quality by Design?

Biorapid was specifically designed around Quality by Design (QbD) principles and Process Analytical Technology (PAT) tools, which are increasingly expected by regulators like the EMA and FDA. The methods align with the regulatory push toward science-based process understanding rather than end-product testing alone.

What therapeutic areas do these methods cover?

The research focused on oncology-related proteins and recombinant proteins for diabetes treatment. However, the project objective states that the resulting monitoring and modelling methods are applicable to other bioactive molecule process development, as demonstrated by validation on a range of relevant bioactives.

Is there still an active team behind this work?

The project ran from 2015 to 2018 and is now closed. The 15 trained early-stage researchers have since moved into industry and academia across Europe. The University of Newcastle upon Tyne coordinated the work and would be the best contact point for accessing methods or connecting with alumni now working in biopharma.

Consortium

Who built it

Biorapid brought together 9 partners from 4 countries (Germany, Denmark, Sweden, UK), with a notably balanced mix of 4 industry and 4 university partners plus one other organization. The 44% industry ratio is high for a training network, suggesting the methods were developed with strong commercial input. The University of Newcastle upon Tyne coordinated, and with only 1 SME in the group, the industrial side was dominated by larger companies — meaning the methods were likely shaped by enterprise-scale manufacturing needs. For a business looking to adopt these methods, the strong industry involvement increases confidence that the outputs are practically applicable, not purely academic.

UNIVERSITY OF NEWCASTLE UPON TYNECoordinator · UK
LINKOPINGS UNIVERSITETparticipant · SE
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITEDparticipant · UK
SANOFI-AVENTIS DEUTSCHLAND GMBHparticipant · DE
RISE ACREO ABparticipant · SE
TECHNISCHE UNIVERSITAT BERLINparticipant · DE
DANMARKS TEKNISKE UNIVERSITETparticipant · DK
CHR. HANSEN ASparticipant · DK

How to reach the team

University of Newcastle upon Tyne (UK) — reach out to the bioprocess engineering or chemical engineering department for the project coordinator

Order a report on this consortium See UNIVERSITY OF NEWCASTLE UPON TYNE profile →

Next steps

Talk to the team behind this work.

Want to connect with the Biorapid team or explore how their rapid bioprocess methods could cut your development timelines? Contact SciTransfer — we bridge the gap between EU research results and industry needs.

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