Production of modern medical devices incorporates a range of materials derived from animal origin. The therapeutic and biocompatibility advantages of animal derived materials (ADM) are well known and well established. They provide benefits over metal or synthetic materials because they can more closely match the biophysical properties of tissues within the human body. ADMs are used in manufacturing of coatings, tubing, connectors, heart valves, bone substitutes, collagen injections, hemostatic devices and tissue sealants. This industry continues to grow and develop new technologies with the key focus on efficiency and productivity. The current trends in system requirements to achieve these goals represent an evolving manufacturing culture influenced by the regulatory quality requirements and the desire to implement new innovative technologies. Among the most important system requirements are: Closed-System Bioprocessing, Single-use, Multi-Products Facility, Quality of sources, Continuous processing, Downstream processing, Time reduction/time to market, and Virus Clearance [Link].
Quality of raw materials and Virus Clearance are regulatory requirements. They ensure safety of products but impact essential systems such as downstream processing and time reduction/time to market. Setting the goal for successful viral clearance at the early stages of product development can significantly curtail this impact on time of downstream processing and increase efficiency and productivity of manufacturing. To asses viral safety of biomanufacturing, every step that can produce virus reduction should be assessed whether this step of processing is dedicated or contributing.
BioScience Laboratories performs Virus Clearance studies for Animal and/or Human Derived Materials. For over 20 years, we have been accumulating data, experience, and knowledge on effective methods and dynamics of inactivation and removal of human and animal viruses, reduction of product and treatment cytotoxicity. We use well established in vitro cell culture techniques to determine virus infectivity and Polymerase Chain Reaction to determine virus removal. BSLI offers expertise in assisting correct choices for effective virus elimination and in testing of efficacy. We can help to determine contributing factors and additional steps and guide your Virus Clearance claim through submission process.
Medical Device technologies utilizing AMD, Soft tissue: • Pericardial patch for use in peripheral vascular reconstruction • Absorbable / non-absorbable meshes (bovine, porcine, fish oil-coated); Woundcare: • Wound dressings, powders, matrices • Collagen dermal template • Haemostats (chitosan, bovine, porcine) • Dental wound dressings: AIMD: Ventricular assist devices; Orthopedic and dental : Bone substitutes • Bone void fillers • Ceramic matrix putty / strips • Resorbable dental membranes; Neurosurgery Vascular: Dural graft • Resorbable nerve products; Vascular: • Gelatin sealed cannulae • Gelatin sealed grafts • Transcatheter heart valve implant device • Pericardial patch for reinforcement of staple lines • Cartilage repair device, etc. [Link]