From Strain Discovery to Regulatory Success
– What Really Matters?

 

Speakers: 
Manuel Porcar Miralles, PhD in Biological Sciences and a senior researcher at the University of Valencia, founder of DARWIN Bioprospecting Excellence
Pauliina Halimaa, Managing Director, PhD, Biosafe


Microbial product development starts with discovery, but promising biology alone does not make a product market-ready. Strains need to be suitable for development, scalable in practice, safe for the intended use and able to meet regulatory expectations in the target market.

In this joint webinar, Darwin Bioprospecting and Biosafe will walk through the critical decision points from strain discovery to regulatory success. The session will focus on what companies should consider early: strain selection, screening, characterisation, safety signals, documentation needs and regulatory viability.

biosafe_webinar_16-6-2026_From Strain Discovery to Regulatory Success – What Really Matters?

Update your knowledge and sign up for the webinar June 16, 2026

10 AM EEST (Eastern Europe)
9 AM CEST (Central Europe)

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Introduction

Biosafe's webinars are open and free for everyone interested in regulatory, safety or scientific issues surrounding regulated microbial products used in food and feed. Our webinars promote discussions, educate professionals and bring out interesting technologies or standards in the field. We welcome your ideas for future topics too.
Tune in and enjoy!

Please join the webinar early to make sure the connection works. 
If you have technical problems, please contact Teemu Kuhmonen.

Program and schedule

8.55 AM CEST (Central Europe)

Welcome and webinar instructions.
Please join the webinar to make sure the connection works.

9.00 - 10.00 AM CEST (Central Europe)
From Strain Discovery to Regulatory Success – What Really Matters?

Speakers: 
Manuel Porcar Miralles, PhD in Biological Sciences and a senior researcher at the University of Valencia, founder of DARWIN Bioprospecting Excellence
Pauliina Halimaa, Managing Director, PhD, Biosafe


Bringing a microbial product to market is not just about finding a promising strain. It also requires understanding early on whether those strains are truly viable for development and able to meet regulatory expectations.

In this joint webinar, Darwin Bioprospecting and Biosafe will walk through the critical steps from critical decision points in microbial product development, focusing on the key decisions that determine success early on.

Darwin will start by presenting how advanced bioprospecting, culturomics, and early-stage strain screening approaches help identify and prioritize high-potential microbial candidates, combining functional insights with early indicators of development feasibility. Real case examples will illustrate how early de-risking improves decision-making before significant regulatory or experimental investment.

Biosafe will then provide a regulatory perspective, highlighting what makes a strain truly regulatory‑viable, common red flags such as antibiotic resistance or insufficient characterization, and how to align R&D work with market access requirements from day one.

Because finding the best strain is only half the journey, the equally important question is: "is it approvable?"


Speakers

Manuel-Porcar-Miralles-400x400px

Manuel Porcar Miralles holds a PhD in Biological Sciences and is a senior researcher at the University of Valencia. He specializes in bioprospecting and microbiology and has been a former member of the Spanish Commission for Biosafety and the Institut Pasteur. He is the author of more than 100 scientific publications and patents.

In 2021, he received the Ig Nobel Prize for his research on the bacteria found in discarded chewing gum stuck to pavements.

In 2016, together with Cristina Vilanova, he founded DARWIN Bioprospecting Excellence, a microbial biotechnology company based at the Parc Científic de la Universitat de València. The company specializes in advanced bioprospecting, transforming microbial diversity into innovative industrial solutions.

Biosafe_-Pauliina-Halimaa_400x400

Pauliina Halimaa is Managing Director of Biosafe and works at the interface of biotechnology, food and feed safety, regulatory strategy and market access. In the webinar, she will discuss how companies can assess the regulatory viability of microbial strains early and avoid common development risks linked to safety, characterisation and documentation.


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More information:

Pauliina Halimaa, Managing Director, Biosafe