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HIGH GROWTH THROUGH CONTINUOUS COMMITMENT TO QUALITY

Our strong professional & management teams consolidate Amatsigroup into a leading CDMO

About Us

A strong track record in drug development services. A continuous integration of innovative technologies and capacities extension.

30

Years of experience

05

Competence Centers

400

Employees

300

Clients

Management Team

AlainSAINSOT

President Pharmacist

Alain has 20 years+ experience in the pharmaceutical industry. Prior to joining Amatsigroup in April 2012, Alain was  the Head of  the Industrial Operations and Logistics Group at Pierre Fabre. At that time he was overseeing overall Pierre Fabre Pharmaceuticals activities (including fine chemicals, pharmaceutical production, supply chain, distribution, and new work environment) and was managing Dermo Cosmetics activities of Pierre Fabre. In 2008, he has set up a plant dedicated to parenteral manufacturing of clinical batches and in 2013, he was nominated President of Amatsigroup. He is also Qualified Person for the Group.

Jean-PierreARNAUD

CEO Veterinarian

Jean-Pierre has achieved more than 35 years in veterinary clinical trials.  Jean-Pierre has worked ten years at Rhone Merieux, then Merial, as a clinician in charge of clinical development for veterinary drug products, then as a clinician in charge of tolerance studies and finally as Manager of the Drug Safety Department.  In 1998, Jean-Pierre co-founded Avogadro company specializing in In Life and Bioanalysis studies. In 2013, he was appointed CEO of Amatsigroup.

ClaireDUBOIS BERGER

General Secretary Business School (ESCP)

Claire has a senior experience in supporting groups growth in integrating new activities and business acquisitions. Her background and skills cover controlling & accounting, project financing, IT, legal and management of support services. Claire will focus on IT including the ERP and integration of subsidiaries, structuring the core system while preserving agility and identity of each entity.

DominiqueVILLARD

Financial Director Master in Finance

Dominique has more than 25 years experience in Finance operations mainly spent in big US companies where he gained a strong background in costing and reporting processes and in other finance related subjects. Dominique has been working at Amatsigroup since 2011 as a Corporate Financial Director. He is in charge of the global financial reporting process aiming at providing appropriate financial information to the Management team and the shareholders, with a specific focus on the P&L and financial metrics. He contributes to positively influence the decision-making process within the Group and its subsidiaries, supporting acquisition initiatives to help the Group growing.

FrédéricGAUSSENS

VP Business Development & Strategy Master Degree of Finance

Frédéric has 10 years+ experience within Life Science outsourcing industry through several managerial positions in Finance, Marketing, Strategy and Business Development across various global companies. Frédéric will focus on key strategic initiatives to support Amatsigroup international expansion: build up and M&A, alliances, partnerships and corporate development, and will bolster the company brand awareness.

AnnieVAN BROEKHOVEN

Biologicals BU Director PhD, Cell Biology

Annie has 35 years+ experience in biologicals. She is a former Innogenetics top executive. She started first as responsible for the bioprocess department.Afterwards, she became Vice-President Biologicals responsible for the process and analytical method development, and production of Biologicals for diagnostic and therapeutic usage, including cGMP manufacturing. She joined Amatsigroup in 2016 when QBiologicals has been acquired to strengthen the portfolio of biopharmaceutical development services.

GeraldDE FONTENAY

Pharmaceutical Analysis Solutions BU Director PhD, Chemistry

Gérald has 20 years+ experience in the pharmaceutical industry. He started his career in the veterinary pharmaceutical industry at MERIAL. He directed several preclinical development studies in the pharmaceutical industry before joining Avogadro, a French-based CRO, where he managed the Pharmaceutical Analysis Department during 13 years. He joined Amatsigroup, in 2014, after 2 years of International Project Management at SGS Life Science Services. His broad analytical expertise encompasses analytical method development & validation, stability studies and QC testing.

YvesGONNISSEN

Formulation Development Manufacturing BU Director PhD, Biochem.Eng

Yves has 15 years of experience in pharmaceutical product development. He holds a Master’s degree in Biochemical Engineering. He obtained his PhD at Ghent University in Belgium where he pursued his research interests in the fields of pharmaceutical technology and pharmaceutical drug product development. In 2002 he started his professional career at Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson). In 2007 he founded SEPS Pharma specialized in drug product development. In 2015, Amatsigroup acquired his company. Ever since, he has managed Amatsigroup services in formulation development & manufacturing focusing on innovative technologies especially for bioavailiability enhancement or oral controlled release.

Jean-FrançoisCORDOLIANI

Head of Pharmaceutical Development Pharmacist

Jean-François joined Amatsigroup as Head of Pharmaceutical Development in 2016. He has a senior expertise of 30 years in pharmaceutical development (Pierre Fabre, BMS &UPSA) on innovative drugs & life cycle management. His key assets: A client-oriented approach, a broad experience in pharmaceutical development strategy and a strong industrial background, including intellectual property. He is specialized also in dermatology and skin care products. Jean-François is in charge of leading the formulation team on French sites & managing the analytical site of St Augustin.

FranckPAVAN

Sterile Manufacturing Site Director Biochem.Eng

Franck has 20 years background in manufacturing sterile products. He is an expert in aseptic manufacturing for high potent, conventional, vaccine products. Highly skilled in isolators, this expertise has been spread worldwide through multiple speaking interventions in worldwide congresses. With more than 16 years experience at Pierre Fabre laboratories on liquid and freeze dried drug products, he managed multiple process transfers for clinical and commercial products manufacturing at a global level. In 2016, he joined Amatsigroup to lead the aseptic manufacturing activities of the group.

Our accreditations

We are committed to the highest quality and regulatory standards.

Our services are undertaken under a GLP (ANSM, ANSES) and GMP environment (ANSM, ANSES, FDA, PMDA, EMA).

We are accreditated by the French government for Research Tax Credit.

Our Clients

Testimonials

Amatsigroup achieved the process transfer of our injectable drug from a major industrial manufacturer and successfully managed the critical step of lyophilization. Amatsigroup has demonstrated its high adaptability to the manufacture of small batches suitable for the orphan drug market. To accommodate our expansion on the Japanese market, Amatsigroup’s team was very reactive and involved and got the Japanese PDMA accreditation within the expected timeframe.

Christophe Pasik, CEO

Keocyt SAS, A Riemser Group company

Amatsigroup is a very expertise based and science driven company focussing on the priorities of the sponsor/client. Over the last five to six years they evolved to  a well-balanced group of highly experienced, flexible and self-driving teams, invested in premises and equipment allowing them to cope with standard and specialty project requirements in the formulation and analytical domain for pre-clinical and clinical needs.

John Oliver, Head CMC Development

Major biotech company

Case Studies

Context

  • NCE with very low solubility
  • Formulation and analytical development
  • Timelines of 12 months for FIH

Challenge

  • API with very low solubility (BCS class IV)
  • High dose to be administered (0.1 to 1g dose for phase I)
  • Short timelines: 10 months from API reception to release of the clinical batch

Solutions oriented proposals

  • Screening of different formulation concepts (complexation, co-solvents, surfactants, aqueous nano-suspensions…) / Knowledge transfer to other Amatsigroup sites for manufacturing and GMP   analytics for selected formulation
  • Weekly calls with the client during complete duration of the project

Key successful outcomes

  • Formulation and analytical methods developed / One formulation selected for FIH
  • Technical batch and clinical batches produced / GMP analytics
  • Strong Project Management to avoid communication gaps and ensure on time delivery

Context

  • European biotech company
  • Precipitation of material at low concentration at 5°C or 20°C
  • Aim for better stability and higher concentrations

Challenge

  • Starting material difficult to handle due to material loss and aggregation
  • Provide a buffer for two monoclonal antibodies to be used as a combination product

Solutions oriented proposals

  • Project performed in 3 phases: screening for an optimal formulation buffer, formulation selection towards individual stability of the monoclonal antibodies and screening for an optimal formulation buffer for the two monoclonal antibodies as combination product
  • Selection based on internal stability data and predictions which were later confirmed by the client during long term stability studies

Key successful outcomes

  • The developed drug product is used for phase 1/2 clinical studies
  • Optimized formulation buffer was found for the combination product of the two monoclonal antibodies

Our partners

ARTES BIOTECHNOLOGY

A technology provider for recombinant protein production, developing and optimizing microbial cell lines and processes for vaccines, biopharmaceuticals, biosimilars and enzymes

Aspe Conseil

A consulting firm specializing regulatory affairs, training and quality in the field of health products

MERCACHEM

A European CRO offering innovative chemistry, medicinal chemistry and process R&D services to accelerate the drug discovery and development process

VALIDAPRO

Expert in pharmaceutical processes, pharmaceutical engineering and regulatory compliance, support for production and compliance projects, from design to inspection by regulatory authorities

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