Liquids Suspensions Gels

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1 Liquids Suspensions Gels

2 EMCM: your product development and manufacturing partner Centre of excellence European Medical Contract Manufacturing (EMCM) is the centre of excellence in developing and manufacturing sterile medicinal products in GMP and ISO accredited facilities, that cater to the markets of innovative Biomaterials, Pharmaceuticals and Tissue Engineering specialties conforming to the standards of the USFDA, EMEA & ISO. With product and process expertise in organic and volatile solvents, aqueous solutions, highly viscous suspensions and gels, EMCM is equipped to produce small scale to large scale batches with a penchant for customised and flexible operations to provide customer specific products under 3 different classifications: Pharmaceuticals, Medical Devices and Tissues. Be it ampoules, vials, pre-filled syringes, pouches, bottles or blisters. EMCM prides itself in being able to support opportunities in (contract) development and manufacturing of specialty products and services, to bring your innovations to the market.

3 State-of-the-art contract manufacturing of Liquids, Suspensions and Gels In-house Technologies EMCM hosts a variety of in-house technologies, retains highly profes sional key personnel, provides flexibility in operations and sustains a wellequipped facility in over 1500 sq.mts of GMP accredited classified areas (clean rooms), conforming to FDA, ISO & GMP standards for compliant manufacturing of medical products. EMCM has 40 active ISO manufacturing clean rooms, which are designed and the manufacturing equipment qualified, to formulate a variety of products. A complete range of formulation vessels and mixing devices provides the solution for the manufacturing of liquids, suspensions, gels as well as powders. EMCM furthermore has Freeze Drying as a technology for manufacture of specialty Pharmaceuticals, Biomaterials and Tissues. While we can assist in process optimisation, validation and upscaling, our core expertise lies in customised batch production with competent formulation techniques, (aseptic) processing and filling coupled with a variety of terminal sterilisation techniques as per the requirements or a complete aseptic closed manufacturing system. Highly viscous and volatile products experience Equipped with a range of (semi-) automatic mixing and filling units, EMCM has proven experience and expertise in the formulation, mixing, filling, packaging and sterilisation of highly viscous products, like temperature dependent suspensions and gels such as hydrogels, collagen and polymers.

4 Ampoules, Syringes, Vials, Pouches Innovations and Product Development Ampoules Two fully automatic filling units for the aseptic filling of organic and volatile solvents and aqueous solutions into ampoules up to 30 ml are in operation. This aseptic process is validated by media simulation and executed by a qualified process team. This filling process can be further extended by inline labeling, a visual inspection machine and the positioning of an ampoule breaker. Syringe Filling EMCM has a semi-automatic filling process for the filling of highly viscous suspensions and gels, in operation in the range of 1 ml - 5 ml syringes. This technology has scope to be expanded for the filling of dual syringes as well as a fully automatic pre-filled syringe (PFS) line. Vial Filling A fully automatic filling unit for the (aseptic) filling of liquids, suspensions and gels into vials is in operation. The line is equipped with stopper/cap closure devices for 13 mm and 20 mm. EMCM has had a long experience in production of collagen in developing combination products with collagen, such as PMMA in collagen suspensions, as well as hydrogels. Highly-purified type I collagen can be obtained from several sources such as tendon, skin and/or pericardium. EMCM has developed collagen purification technology to enhance the yield of highly purified collagen from tendons to include as starting material for various dermatological and regenerative medicine applications, as well as in the development of soft tissue constructs. Besides the core knowledge on production and up scalability, various combination products using Hydrogels, such as Hyaluronic Acid, Carboxy Methyl Cellulose, Gelatin are being explored together with drug delivery and peptide release systems on semi-solid and Allograft based carriers. Pouch Filling On special customer request we design filling equipment for the filling of custom-made primary packaging. A dedicated custom-made filling line is available for the filling of liquids into aluminium pouches. This filling unit can be made suitable for filling of any dedicated filling unit. LSG

5 Quality Systems More services from EMCM Packaging Tissue Powder EMCM is an ISO 9001:2008, EN ISO 13485:2003 & CAN/CSA ISO 13485:2003 certified company which acknowledges the compliance maintained in business practices, as well as manufacture of medical devices. EMCM possesses a Good Manufacturing Practice Licence for the manufacture of Pharmaceuticals and also a Tissue License for the storing, processing and distribution of human tissue. For the above, we are subject to several national, European, US (FDA) and international (ANVISA) inspections to be able to manufacture products for global markets. Our spectrum of Contract Manufacturing activities ranges across the segments of custom Pharmaceuticals, Tissue Products, specialty Biomaterials and more. Powders For the mixing of powder components a medium scale powder mixer, including a range of sieving devices, is in operation to guarantee a homogenous bulk product. Semi-automatic equipments are used in each of these disciplines. The equipment is operated by qualified operators and controlled by product specific qualification and validation programs. EMCM has the possibility to fill powder into vials, pouches and small containers. Tissues EMCM possesses a licence to store, process human tissue by gas extraction under Super Critical Conditions and distribute human tissue and provides these activities as a service to international tissue banks and customers. With our philosophy of Supporting Opportunities, we are sensitive to the needs of our customers and balance the act of providing high quality and reliable product development and manufacturing opportunities, with a good amount of flexibility. Human tissue is received from tissue banks, processed (cleaned and sterilised) and packed as a dry, finished product in dimensions as per the request of the customer, which can be stored at room temperature. The tissue business is being expanded via the inclusion of a hard and soft tissue product portfolio, which has unique safety features, including virus inactivation. Customised service package EMCM provides a complete custom-made service package from product development through purchasing, manufacturing, sterilisation, final packaging, warehousing and logistics. We continuously work with our clients to ensure how we can optimise their operations and also cater to ever increasing requirements posted by their innovations.

6 Why EMCM? EMCM Supporting Opportunities LSG As a customer driven organisation that believes in contributing to the quality of life by delivering high quality products and services, EMCM incorporates a no-compromise on quality policy, your innovations are delivered in the safest of environments. Established academical network and associations with relevant organisations for innovative projects. At EMCM, our core focus is to harness our in-house expertise and fulfill a need in the medical sector by developing products that target specific segments. By actively collaborating with various R&D centers globally, EMCM aims to accommodate the latest innovations that complements her existing portfolio and areas of expertise. EMCM co-operates with global companies as well as works with various European and national universities in research and developmental projects that are aimed at increasing the depth of our existing portfolios. We continuously look to enhance our existing products and expand their distribution in global markets through innovation and research. The EMCM advantage EMCM prides itself in being able to support innovations and breakthroughs in the healthcare sector that will positively impact the lives of millions worldwide. If you have an opportunity, you can rest assured EMCM will support you. We support opportunities while you deliver them, through: B2B model for development and manufacturing Compliant and reliable Quality Systems End-to-end service solutions Up scaling, process validation, production, packaging, warehousing and distribution Fully licensed GMP operations Support in sales and product registration Flexibility to ensure your innovation is on the market

7 Website Telephone number Phone: address Address EMCM B.V. Middenkampweg CH Nijmegen The Netherlands EMCM part of aap Implantate AG