What you need – but not more. Guiding your Process Development, to serve clinical trial and commercial needs. Facility planning and commercial-scale Advanced Therapy manufacture to your needs.
Processes for Advanced Therapy production are frequently developed out of research environments, and they use approaches, ingredients and controls suitable for such environments. For Advanced Therapies intended for human application, however, all ingredients, tools and processes need to be compliant with rules set forth for human application of medicinal products, and production processes will have to meet Good Manufacturing Practice (GMP) standards. Advance Therapy processes tend to employ agents and components otherwise not used for the manufacture of medicinal products, thus presenting particular difficulties in regard to approvals. One prominent example are bovine serum products – a complex product of animal origin which requires safeguards against transmission of bovine pathogens Transmissible Spongiform Encephalitis (TSE).
In general, Advanced Therapies typically originate from R&D projects where the choice of raw materials is based on parameters other than regulatory compliance. When converting such processes into a product appropriate for human application, choosing materials according to quality aspects becomes an urgent need. Mares Ltd. uses its expertise to ensure choosing the right materials and technologies.
We develop manufacturing processes and/or adjust your processes such that the resulting products meet relevant guidelines and hence are approvable and economically feasible.
Many Advanced Therapy products rely on manual aseptic processes, during which open product is handled. As these products cannot be sterilized terminally, maintaining the aseptic status throughout the process is the key.
We develop processes, Standard Operating Procedures (SOPs) and controls to facilitate this. Also, we design facilities supporting such aseptic processes based von EU-GMP, ISO guidelines as well as relevant US requirements:
We have accumulated decades of experience in planning and realizing processes and facilities, the latter around specific processes with hygiene levels ranging from class A to class D according to e.g. EU clean room classification.
Facilities for manufacturing aseptic products not terminally sterilized (e.g. living products) require manufacture acc. to EU GMP Annex 1 or respective US or similar guidelines. We have accumulated decades in experience in planning and realizing facilities around specific processes with hygiene levels ranging from class A to class D according to, e.g. EU clean room classification including particle levels, viable particle levels, settling and contact plate analyses.
Concomitantly, process steps require individual risk assessments informing the design of control steps across a process.
Mares Ltd. can provide both adequate facilities and process controls.
Manufacturing ATMPs for early research requires few product units, clinical trials may require hundreds, possibly thousands of units and commercial-scale manufacturing is essentially open ended. Technologies facilitating production of such different volumes differ vastly and require qualification and validation – time consuming activities. Thus, they need to be planned for and implemented early to be ready when needed.
Frequently, innovators choose to manufacture/produce their products in dedicated facilities. These facilities need to be GMP compliant – particularly for aseptic manufacture.
With decades of experience and a proven track record in developing, planning and realizing cell processing and tissue engineering plants, Mares Ltd. ensures that your production facility complies with pertinent standards.
"Stempeutics requested Dr. van den Bos assistance as strategic/technology advisor and subsequently expanded his responsibilities to include that of head of manufacturing directing our production of cell based drugs and cosmetics. Throughout the continuing interaction we have been impressed by the mix of expertise and hands-on approach in attaining Stempeutics’ goals including all production-related topics, upgrading an existing aseptic production plant and European affairs. Mares has shown great flexibility in reacting to our needs and we consider Mares Ltd. a valued partner for our strategic and technological development.“
Pisharody Vijayaraghavan / General Manager HR & Shared Services
For our client Stempeutics we provide strategic and technological advice and hands-on support for their production of stem cell based drugs and cosmetics. Stempeutics is a leading Stem-Cell Company developing stem cell based medicinal products, with facilities in Bangalore and Manipal (India) as well as in Kuala Lumpur (Malaysia). It was incorporated in Jan 2006. Stempeutics strength lies in developing innovative stem cell products by nurturing cutting edge research and clinical applications through dedicated efforts of its highly qualified team. Scientists working at Stempeutics have filed over 25 patents and have published over 50 peer reviewed international publications. Stempeutics is committed to deliver safe, effective and affordable stem cell products in a "Bench to Bedside" approach.