Updated on 11 December 2012
Once the sub-assemblies of a device are produced, the next step is integrating them with the biologic-filled primary container to create a completed combination product. Biopharmaceutical companies basically have three options to consider at this stage: do final assembly themselves, outsource to a third-party, or find a drug delivery device partner that can provide this service.
In response to customer requests to provide final assembly of combination products, many device suppliers, including SHL, offer final assembly, labeling and packaging services for devices to pharmaceutical and biotechnology companies. In the case of SHL, a specialized company, SHL Pharma, was established, streamlining the production and distribution process for SHL medical products and improving end-product quality and speed-to-market for customers.
From a quality and regulatory point-of-view, final assembly facilities should be ISO13485 certified and registered with the FDA as a drug establishment, qualified to handle and distribute pharmaceutical products. Additionally, they should conform to all other regulatory requirements for medical devices and pharmaceutical packaging and distribution, as per 21 CFR Parts 820, 210 and 211. The staff involved at this level will have both drug and device expertise to help ensure the safe production of the combination product.
In addition, when a project will soon enter the final assembly stage, there are a number of new considerations that also must be addressed, such as types of packaging, labeling, instructions for use [IFUs], inserts and more. Protective packaging not only holds the device for shipping, it helps to protect it if designed properly. Clear IFUs will also help to ensure that end-users know how to use your combination product properly. Drug delivery device suppliers should independently, or in cooperation with external experts, be relied upon for guidance in these areas.
Inspiring integration and the way forward
Enhancing the convenience and ease of administering biologics is a proven strategy for biopharmaceutical companies to augment product differentiation and to compete in an increasingly competitive market. As patients become more familiar with various types of drug delivery devices, they will expect suppliers of these devices to continue to innovate and to take their true user needs into consideration. Biopharmaceutical companies that pro-actively partner with experienced drug delivery device suppliers will be able to ensure that such needs are met and that projects can be completed on time.