Enabling Large-Scale GMP-ready Peptide Production with a new, reliable and cost-efficient Bioprocess

Project Information

NUMA-SCALE

Grant agreement ID: 836885

DOI

10.3030/836885

Project closed

EC signature date 29 November 2018

Start date 1 November 2018

End date 28 February 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

NUMAFERM GMBH
Germany

Periodic Reporting for period 1 - NUMA-SCALE (Enabling Large-Scale GMP-ready Peptide Production with a new, reliable and cost-efficient Bioprocess)

Reporting period: 2018-11-01 to 2019-02-28

Summary of the context and overall objectives of the project

Peptide therapeutics are progressively gaining the attention of Pharma and Biotech companies as they possess desirable pharmacological profiles and their specificity translates into outstanding safety, tolerability, low toxicity and efficacy profiles in humans, in contrast to traditional small molecules. With the increase of approved peptide-based drugs, the production of peptides will escalate but peptide manufacturing companies face a several challenges in their production processes, (e.g. high production costs and bad scalability) which results in shortages of peptide APIs in the market.
Numaferm is a German company, focus on making peptide production more cost-efficient and sustainable for the pharmaceutical market. We have developed an innovative bio-based process for peptide production that copes with the challenges of the current peptide production methods. It consists of 2 patented technologies, NUMAtag and NUMAswitch, whose unique features are: cost-efficient production (50x manufacturing costs reduction); sustainability (reduced carbon foot print by >90%) and scalability (ton scale, no peptide length limitation).
Currently, we produce peptides as APIs for customers at discovery and pre-clinical stages (max. 1gr, research grade) and through the Numa-Scale project we aim to evolve to next stage (i.e. clinical development, 250gr scale, GMP grade).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Our key achievements include: technical development of our innovative processes, implementation of the first customer projects and patent application and granting.
In this feasibility study we have analyzed our core-technologies and identified the technical improvements necessary to upscale our production, work on the quality requirements for pharma industry and extend our commercial capabilities. Besides, to assess the commercial feasibility of our project we conducted an in-depth analysis of the peptide therapeutics market (its dynamics, environment, target customers, competitors, barriers and mitigation measures), and we have also updated the FTO analysis.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Our value proposition to Pharma and Biotech companies (our customers) includes: Scalability (up to ton scale), no peptide length limitation (accessibility to large peptides), high peptide purity (over 99%) and reduction on R&D time due to shorter production times (6 months vs 1-3 years).
The Numa-Scale project will have a positive impact on economy and society as it will result in more affordable and accessible treatments for numerous diseases.

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