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.
Merck launches first-to-market, cyber-physical trust platform to tackle issues of product safety and counterfeiting
M-Trust™ is a secure cyber-physical trust platform that enables the creation of digital twins for enhanced product quality and authenticity assurances This cutting-edge new technology is being unveiled at CES 2025, the proving ground for breakthrough technologies M-Trust™ platform is being launched in beta for immediate use by B2B users globally. 7 January 2025 --...
Merck Receives European Commission Approval for WINREVAIR™ (sotatercept) in Combination With Other Pulmonary Arterial Hypertension (PAH) Therapies, for the Treatment of PAH in Adult Patients With Functional Class II-III
26 August, 2024 – New Jersey, US – Merck, known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II...
MSD’s WELIREG▼(belzutifan) made available for the treatment of eligible adults with von Hippel-Lindau (VHL) disease in Scotland
Scotland is the first European country to accept belzutifan as a treatment for adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumours (pNETs), and for whom localised procedures are unsuitable or undesirable. In a phase II study, belzutifan demonstrated...
Cancer immunotherapy basket trial leads to NICE recommendation for MSD’s KEYTRUDA (pembrolizumab) as a treatment option for adults with previously treated endometrial, biliary, colorectal, gastric and small intestine cancer with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR)
The results from the basket trial show that pembrolizumab monotherapy demonstrates clinically meaningful data to patients with MSI-H or dMMR solid metastatic tumours, across the five tumour sites evaluated, with respect to objective response rate (ORR). Compared to a traditional trial, a basket trial tests a drug on multiple types of cancer with the same...
Merck Expands Life Science Production Capacities in the United States
Expansions to significantly increase capacity by end of 2021 to meet unprecedented demand Combined expansion of Danvers, Massachusetts, and Jaffrey, New Hampshire, USA facilities to create nearly 700 new positions Business sectorís announced 2020 investments total more than Ä 350 million
Merck Becomes One of the First CDMOs to Provide Full Viral Vector Offering with Launch of VirusExpress 293 Adeno-Associated Virus Production Platform
09 Aug 2022, Darmstadt, Germany: Merck, a leading science and technology company, has launched the VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform, making it one of the first CDMOs and technology-developers to provide a full viral vector manufacturing offering including AAV, Lentiviral, CDMO, CTO, and process development. This new platform enables biopharmaceutical companies to increase...
Merck Announces Collaboration with Agilent Technologies to Fill Industry Gap in Process Analytical Technologies for Downstream Processing
Darmstadt, Germany, June 14, 2022: Merck, a leading science and technology company, today announced that it has entered a collaboration with Agilent Technologies to advance Process Analytical Technologies (PAT). PAT, which is strongly encouraged by global regulatory authorities, is a key enabler for real-time release and Bioprocessing 4.0.
Merck to Provide BioReliance End-to-End Solutions to Phanes Therapeutics
ï Collaboration to accelerate development and manufacturing of Bispecific Antibody ï Merck plans to offer Phanes a full suite of products and services under its BioReliance offering
Merck Introduces New Integrated Plug & Play Upstream Development Service
ï Adaptive approach to cell line development, analytics and clone selection for emerging biotechs and start-up ï Tailored upstream development from a single source reduces time to clinic by 20 percent ï Fast-track process reduces timeline by 10 weeks for first pharmacodynamic experiment
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.
1 rue Jacques Monod, Site Montesquieu, 33650 Martillac, France
+33 (0)5 57 960 960
