NEWS

For many biotech companies, the early stages of development are dominated by scientific discovery and proof of concept. Once promising data begins to emerge, attention quickly shifts to the next challenge: how to translate a promising molecule into a manufacturable, scalable and regulatory-ready product. This is where Chemistry, Manufacturing and Controls (CMC) becomes critical. As discussed in our article on developing a robust CMC strategy early in biotech development , dec

For US biotech companies, CMC rarely stays inside one country. Even programmes that start with a single CDMO often end up split across regions: process development in one place, GMP manufacture somewhere else, and analytical testing handled by a specialist lab with its own timelines and constraints. Sometimes that’s deliberate. Often, it happens because a vendor can’t take you into the next phase, a slot disappears, or you need to manufacture closer to the clinic. Core techni

Early-stage CAR-T programmes are often driven by urgency. Yet progression to the clinic is rarely constrained by science alone. More often, it is determined by whether manufacturing processes, quality systems and regulatory Chemistry, Manufacturing and Controls (CMC) documentation are ready to support clinical supply. This article explores this, using an emerging biotech developing an autologous CAR-T therapy for oncology.

A look back at the realities of 2025 and the lessons shaping biotech’s path into 2026 As 2025 draws to a close, biotech finds itself in a complex but defining phase. The pace of scientific innovation is accelerating, especially in discovery and design, but success increasingly hinges on execution, CMC readiness and the ability to move into the clinic efficiently. This contrast between scientific momentum and operational challenge has shaped much of the year. Funding remains a

Early-stage biotech development has never been more complex. With pressure to move faster, demonstrate robust data earlier, and meet rising regulatory expectations, many teams struggle during one of the most critical phases of the journey: lead optimisation. Today, 3Biotech is pleased to introduce our new whitepaper, Strategic Lead Optimisation and Selection, which explores how early CMC insight can transform development outcomes and reduce risk for small and mid-sized biotec

Developing a promising biologic candidate is only the first step on the long path to delivering a safe, effective, and commercially...

Safeguarding safety and efficacy from day one Failing to clearly define quality targets early in biotech development can have serious...

Drug development is an inherently high-stakes endeavour, with failure rates in early phases reaching up to 90%. For emerging biotech...

The good news? There’s still plenty of opportunity for companies that prepare well. Here’s what biotech startups need to know to attract...

Why biotech companies need the right CDMO partner Biotech companies - particularly early-stage or small-to-mid-sized firms - often face...

In recent years, Artificial Intelligence (AI) has begun to play a transformative role in the biotechnology and pharmaceutical industries....

Biotech innovation doesn’t happen in a vacuum. Behind every successful molecule reaching clinical trials is a seamless CMC strategy...

Olivier Favre-Bulle, founder of 3Biotech , shares his insights on the pressures facing the French biotech sector and the opportunities...

A roadmap for success in Biotech The development of biotech and biological medicines is a highly complex process that goes beyond...

A Vision to Revolutionize CMC Support for Early-Stage Biotech Founded by Olivier Favre-Bulle in 2014, 3Biotech was born from the desire...

A well-structured Chemistry, Manufacturing, and Controls (CMC) strategy is essential for the successful development of biologics. For...

3Biotech has announced a new collaboration with Cartelis, a data and CRM operational consulting firm, to explore innovative ways to ...

Founder and CEO of 3Biotech, Olivier Favre-Bulle was awarded the "Cercle des experts Bpifrance" label at the 9th edition of the BIG...

Valuable conversation between Elio di Rupo, Minister-President of Wallonia and former Prime Minister of Belgium, ...

Dominique Demonte, Head of the Brussels South Charleroi BioPark (Belgium) and Catherine Muller, Executive VP at 3Biotech, have ...

3biotech joins BioWin, Wallonia's biotech research organization...