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Merck

Many Parameters along Your Journey

No two drug developments are ever the same. We understand you need to adapt to an unpredictable journey with changing priorities along the way. Whether you have never brought a product to market before or need a CDMO that can build upon your experience, we help you make the critical decisions that will impact your drug development journey, conscious about time and cost.

Adaptive CDMO Solutions

We offer CDMO solutions adapted to your projects needs, even if your needs are changing. Because we are a small and flexible organisation backed by Merck with more than 56.000 employees, we bring you a wealth of in-house expertise. We are the CDMO within Merck that helps biotechs develop their biologic drug candidates from DNA to market. We are BioReliance® End-to-End Solutions.

BioReliance® End-to-End Solutions

We are an adaptive contract developer and manufacturer that helps start-ups and small biotechs reach their next milestone with the right balance between cost, risk and speed to clinic and offers custom solutions and expertise from pre-clinical to commercial:

Cell line development
Cell banking
Analytical development
Process development
GMP manufacturing
Product characterisation
Lot release testing
Process validation, scale up and transfer
Regulatory and Quality support

Our History

Our biodevelopment center in Martillac started in 1987 as a CDMO, which was acquired by Serono to become an in-house discovery, development, and manufacturing function for Merck Healthcare. Since 1995 the Martillac site is GMP certified. The site was upgraded to a fully single-use platform in 1992, when we began offering again services externally and creating GMP batches for clients. Biodevelopment centers were opened in Boston, USA and Shanghai, China in 2017 for non-GMP clinical production. In 2020, we will open our GMP facility in Shanghai.

Our Experience

33 years in process development, 23 in GMP production
250+ biologics (antibodies, hormones, fc-fusion and recombinant proteins)
75+ GMP Drug Substance for unique molecule released since 2012
80% Fed batch, 20% Perfusion
100% scale up success rate
97% Clinical GMP production success rate
Build or expand Single-Use PD/GMP facility in <1 year

How we work with you

We start with establishing your strategy and offer custom solutions that take into account our clients project needs. How fast do you need to go? What is the level of risk you are willing to take? These are questions we address and based on our experience we help our clients balance cost, risk and speed to clinic without ever sacrificing quality. Our regulatory advisers represent our clients in front of regulatory bodies to show that patient safety is guaranteed throughout the process. Our dedicated project managers allow us to function like an extension of your team. We emphasise transparency and connect you directly with our experts. When you decide to transfer your process, we support your tech transfer to your facility or to any partner.

What you can expect

A flexible approach to balancing cost, risk and speed to clinic
In-house expertise that helps you take informed decisions
Complete end-to-end or à la carte services
No upfront payment or booking fees
Freedom to tech-transfer at any stage, to any partner
Optionality through access to the latest technologies and deep development expertise

Did you just get funding? Or are preparing to get to clinic and IND filing? Contact us today to talk about your next steps.

UK Medicines and Healthcare Products Regulatory Agency (MHRA) Issues an Early Access to Medicines Scheme (EAMS) Positive Scientific Opinion for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations

Feltham (Merck) - Merck announced today that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for tepotinib for the treatment of adult patients with advanced Non-Small Cell Lung Cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.