We support biotech/pharmaceutical companies in commercializing advanced-therapy medicinal products (ATMPs)

Turning Innovation into Products

Gene- and cell therapeutics as well as tissue-engineered products offer fundamentally new treatment opportunities for unmet medical needs. In Europe, such products are called "Advanced-Therapy Medicinal Products", or ATMPs, denoting them to be a third class of medicinal products in addition to drugs and medical devices. To market such products in the EU, a market of 500 million people, specific regulatory, quality and process parameters have to be observed.

 

Mares Ltd. provides the necessary knowledge and experience to do so.

 

We accelerate manufacturing, clinical and regulatory processes – so that innovators can market their products and patients in the European Union and elsewhere can benefit from efficacious and safe new advanced therapies.


 

Solutions for Each Stage of the Value Chain

ATMP Life Cycle Prclinical Tests Process Development Manufacturing Authorization Audits Audits Clinical Trial Dossiers Clinical Trials Marketing Authorization Upscaling Audits Audits

Preclinical Tests

Once a promising advanced therapy candidate is identified, preclinical work needs to be carried out in such a way that, if it yields desired results, these will be of a quality approvable when submitted to authorities in e.g. a clinical trial application. Key topics include Good Laboratory Practice (GLP) and scientifically and statistically sound models. 

 

Particularly for investor interactions it might be useful to have an official stamp of approval as provided by EMA through their certification program.

Mares Ltd. offers to

    • Support your scientific explorations
    • Identify and execute relevant pre-clinical work with trusted partners
    • Identify and coordinate with suitable CROs
    • Identify and coordinate with suitable statistics groups
    • Ensure GLP compliance
    • Prepare all necessary documents and obtain e.g. EMA certification for preclinical work

    Process Development

    Once evidence has been gathered supporting the ATMP candidate, the manufacturing process needs to be reviewed and designed such that it is robust, approvable and renders production economical.

    Mares Ltd. offers to

    • Develop robust and approvable production processes
    • Scale up/out production processes such that desired quantities of your product can be manufactured according to Good Manufacturing Practice (GMP)

    Manufacturing Authorization

    Once a company or academic group plans to produce a drug intended for human use in the European Union, it needs a manufacturing authorization. This includes a full review of the processes, the manufacturing plant and associated quality documentation by the competent authorities; in Germany this may include district governments and the Paul Ehrlich Institute.


    For investigational medicinal product as well as for commercial products manufactured outside of the EU, an import license is required. This entails reviews by the authorities similar to that for a manufacturing license, Qualified Person (QP) release plus a legal representation within the EU. 

     

    Mares Ltd. offers to

      • Design and implement aseptic facilities, processes and quality systems compliant with EU regulations
      • Obtain manufacturing licenses
      • Obtain import licenses
      • Provide importation and QP release
      • Provide legal representation in the EU

      GMP Audits

      The manufacturer/marketer of a medicinal product is responsible for the quality of their product including all of its ingredients and contract manufacturers/contract analyses. To meet this responsibility, typically audits are carried out at the site of the relevant party.

      Mares Ltd. offers to

      • Audit both processes and quality systems at suppliers, contract manufacturers and contract analytical entities
      • Conduct mock audits, prepare for GMP inspections by the competent authorities

      Clinical Trial Dossiers

      To obtain approval for a clinical trial, the investigator or sponsor, often a company, needs to submit various formalized documents including an Investigational Medicinal Product Dossier, an investigator’s brochure and an ethics committee application.

       

      Mares Ltd. offers to

        • Write and submit all required documents according to local and EU specifications
        • Liaise with the regulatory authorities
        • Drive the approval process

        Clinical Trials

        Demonstrating safety and efficacy of an ATMP in patients is a critical task. It requires, amongst other things, an expert clinical trial design including sound selection of patients and endpoints.

         

        Mares Ltd. offers to

        • Conduct clinical trials with trusted partners

        Marketing Authorization

        For ATMPs, a centralized procedure has been put into place for obtaining a marketing authorization

         

        Mares Ltd. offers to

        • Write and submit all required documents according to local and EU specifications
        • Liaise with the regulatory authorities

          Upscaling

          Depending on the requirements of the Innovator, clinical trial or commercial-scale manufacturing processes need to be in place and ready to go. For ATMPs, the desired production volume is likely to dictate specific production technology platforms which require ramp-up times and suitable supporting technologies such as for down-stream-processing and long term storage.

           

          Mares Ltd. offers to

            • Select / develop / implement suitable manufacturing processes for your ATMP at the desired scale
            • Scale-up production and secure aseptic manufacturing processes
            • Find suitable contract manufacturers for individual production stages, where necessary and/or advisable