We offer a broad range of clinical manufacturing services for recombinant proteins. We understand your need to outsource and offer to help you (I) meet regulatory requirements in terms of documentation and data retrieval, (II) avoid building, maintaining, and operating clean room facilities, and (III) adhere to the strict EMA and FDA guidelines.
It is ingrained in our company culture to always suggest manufacturing equipment for clinical manufacturing that is in line with the equipment to be used for commercial manufacturing. It is therefore deemed crucial to first understand commercial manufacturing scale and perceived process, as this will ensure a smooth transition of the candidate product from clinical trials to a commercial manufacturing setting. We accommodate a variety of clinical manufacturing platforms, including a stirred tank 200 L bioreactor, single-use bioreactors, spinner flasks, shake flasks, roller bottles and cell factories to produce drug substance.
All our systems and procedures are developed and maintained to ensure compliance to applicable FDA and EMA regulatory requirements and standards. Our Quality Team oversees the entire production process from the validation of equipment to the approval of the documents required to release your product. Overall Quality Review is performed during quarterly meetings with executive management, focusing on adhering to the auditing scheme, critical and major observations (if applicable), numbers of open quality incident reports, changes and CAPAs closure within due date and trends.
We have successfully built a system in which the team of experts developing the processes in an R&D environment, also performs the clinical manufacturing in GMP. This approach has proven to eliminate time-consuming and error-prone technology transfer processes. Our dedicated team of experts is also closely involved in transferring the manufacturing process to the customer’s late stage or commercial manufacturer.
We operate grade B and C clean room facilities. The facilities have dedicated upstream and downstream suites, equipped with a variety of manufacturing platforms. The facilities are supported by GMP materials warehousing and storage areas. Storage is available at room temperature, 5°C, -20°C, -80°C and in liquid nitrogen, with dedicated space for drug substance and drug product stability testing. Our GMP facilities are regularly audited by regulatory authorities and customers. We are proud to host more than 8 audits each year and have passed every audit with flying colors as none of the audits have demonstrated critical observations.