A large diagnostic manufacturer developed a molecular diagnostic instrument featuring multiple in vitro Diagnostic (IVD) and Research Use Only (RUO) assays formatted as 15 individual kits. Soon after, corporate restructuring at the firm resulted in the planned divestiture of the manufacturing plant producing the reagent kits for this platform. The prospective client was facing a future with no facilities capable of manufacturing these complex reagents. They needed to find an OEM partner that could manufacture their kits under the required ISO 13485 quality systems and FDA certification. After multiple visits to various prospective OEM manufacturers the client selected two OEM partners, one being us. The diagnostic manufacturer initially began technical transfer with both our company and the other selected supplier, believing this provided the best opportunity for a primary and secondary source of supply. After six months, the transfer progress to our organization far exceeded all expectations due to our diagnostic manufacturing expertise, dedicated project management, open communications and adherence to timelines. Through our fully integrated ERP system and multiple ISO 13485 certified sites, the client was able to satisfy the requirement for continuity of supply, which was the original intent of a dual company selection. The diagnostic manufacturer thus awarded the full supply agreement to us.
We set up a dedicated product transfer team to support the complex task of translating hundreds of manufacturing documents, product numbers and label requirements into our fully-integrated manufacturing ERP. Expert Quality Control teams conducted method verification and/or validation on 74 client QC methods required for the manufacturing of over 100 intermediates and 15 finished kits. Each custom kit had its own unique record, which included a customer defined master manufacturing formula (MMF), master packaging formula (MPF), quality control report (QCR) / final product specifications (FPS), raw material specifications (RMS) and label text form (LTF). A complete batch record is generated with each new lot and maintained on file.
Our highly-skilled tech transfer support team, along with manufacturing engineers, QC and QA experts, worked to install on-site customer instruments required to do final functional QC testing of the products that run on the platform. Through travel to the client’s site the dedicated support team maintained open communication to ensure the details of the manufacturer’s QC methods were efficiently transferred to the MilliporeSigma team. A stability program was also set up for real-time stability testing of the key intermediates and final kits now being produced in our facilities. Packaging engineers constructed the custom packaging lines required to package and label the customer‘s kits.
Seamless product and technical transfer resulted in final kits that were identical in both form and function to those previously produced by the client in-house. This allowed for no interruptions in supply or obvious kit changes for the end users. The client was able to secure consistent supply from a single OEM partner in order to support increased kit demand. Further diagnostic R&D is currently underway at the client site to expand the number of kits offered for this platform technology. We have been selected as the exclusive OEM partner to do the scale-up and transfer of these additional kits, due to the successful transfer and exceptional experience the diagnostic manufacturer had with the custom development, manufacturing and packaging of the initial 15 IVD and RUO products.