Manufacturing

Delivering world class contract manufacturing services

Manufacturing

Leader Biomedical’s contract manufacturing operations (CMO and OEM) possess ISO 9001:2008, EN ISO 13485:2012, and EATB certifications and adhere to strict regulatory, and business practices.

We have GMP Licensed organisations, processing a broad range of healthcare products for the pharmaceutical, medical device, and tissue sectors of the healthcare industry. Our Dutch subsidiary, EMCM, has been successfully inspected by the USFDA, ANVISA, and other European authorities for providing products to the global markets. According to standard procedures, we perform validation and/or verification of processes, qualification of equipment, utilities, and analytical methods. All critical processes for manufacturing biomaterials and pharmaceuticals are validated. Please refer to the subcategories to find a detailed overview of our services and expertise in a particular field.

Liquids, Suspensions, Gels

Leader Biomedical Group’s contract manufacturing operations (CMO) deliver a wide variety of biomedical products ranging from volatile liquids, high viscous suspensions, and gels for orthopaedic, dental, medical aesthetic, and niche pharmaceutical applications.

Our facilities are able to support manufacturing operations for ampoules, vials, pre-filled syringes, pouches, bottles, and blisters. We are experts in bringing your innovations to the market, showing a high degree of flexibility to meet your needs. We host a variety of in-house technologies, retain highly professional key personnel, and have a well-equipped Dutch based facility with over 1,500 square meters of GMP accredited classified areas, conforming to FDA, ISO & GMP standards for the manufacturing of medical products.

 

Formulation and filling of ampoules, syringes, vials and pouches
We possess a range of (semi-) automatic filling units for the filling of organic solvents, aqueous solutions, gels, and suspensions. All filling processes can be performed under aseptic conditions and will be validated by media simulations according GMP and ISO requirements. The formulation of all liquids, gels, and suspension can be executed under class A/B aseptic condition before filling in the required primary packaging.

Powders

The Leader Biomedical Group possesses medium scale powder mixers, including a range of sieving devices, to mix powder components, and to guarantee a homogenous bulk product.

Semi-automatic equipment is used, which are operated by qualified operators and controlled by product specific qualification and validation programs. We are also equipped with a range of (semi-) automatic filling units to fill powder into vials, pouches, and small containers.

 

Biologics

EMCM, our Dutch subsidiary, has a license (European Directive 2004/23) to produce human tissue allografts. We also provide xenografts made from collagen, both of which are sterile and comply to all the quality requirements of European regulations for the quality and safety of human tissues.

 

Allograft products
The products manufactured are human donor tissues processed for use in orthopaedic, dental, trauma, and sports procedures. Depending on the use of the allograft, different forms and shapes can be manufactured. The volume can be tailored to your needs and the products can be enriched by impregnating them with infection controlling agents such as antibiotics.

 

Xenograft products
Collagen tissue engineering products (Xenografts) are derived from dermal, pericardial or tendon animal tissue and are increasingly used for repair and reconstruction in the field of maxillofacial, cosmetic and plastic surgery, wound management, and urology.