Meet the Expert: Pim, GMP Scientist
One of the most sought-after outsourcing demands in life sciences is clinical GMP manufacturing and release of biopharmaceutical products to allow subsequent testing in human subjects for safety and efficacy. Globally the market for this outsourcing activity is estimated at about $3 billion annually, of which about 85% is accounted for by biotech companies and the remainder by large biopharmaceutical companies.
The arguments for biotech companies to outsource this activity to third party vendors may be apparent as (I) meeting regulatory requirements in terms of documentation and data retrieval require highly trained staff and a highly matured IT infrastructure, (II) building, maintaining, and operating clean room facilities is expensive thus requiring such facilities to run at full occupancy, and (III) the entire product manufacturing and release trajectory requires intimate oversight for QA and QC to ensure that every step in the process adheres to the strict guidelines set by regulatory organizations like EMA and FDA.
When selecting a partner for clinical manufacturing there are several logical guidelines to follow to prevent surprises during the execution of the project and during the release of the batch. Here are a couple of examples.
The CDMO company’s quality systems and procedures should be developed and maintained to ensure compliance to applicable FDA and EMA regulatory requirements and standards. The Quality Control and Quality Assurance team (QA/QC), headed by a Qualified Person should oversee the entire production process from the validation of equipment to the approval of the documents required to release your product.
Make sure the CDMO company culture is to only suggest to its sponsors the use of manufacturing equipment for clinical GMP manufacturing that is aligned with the equipment to be used for commercial manufacturing. It is crucial to first understand the commercial manufacturing scale and process as this will ensure a smooth transition of the candidate product from clinical trials to a commercial manufacturing setting.
Freedom to operate
A thorough and broad understanding on intellectual property restrictions on technologies, manufacturing platforms, and raw materials is crucial to develop processes that guarantee freedom to operate moving forward from bench to market.
Many CDMO companies have a development department completely separated from the manufacturing department. This implies the need of an internal tech transfer. A system whereby the team of experts developing the upstream and downstream processes in an R&D environment, also performs the clinical manufacturing in GMP, has benefits over the traditional structure. It has proven to eliminate time consuming and significantly limit error-prone technology transfer processes. Additionally, watch for an experienced team of experts that is intimately involved in transferring the manufacturing process to the client’s late stage / commercial manufacturer.
Naturally, the CDMO company should have a facility that matches the requirements for the of your product. Do you require grade A, B or C clean room facilities for the production and purification of your biopharmaceutical? Does the facility have dedicated upstream and downstream suites to avoid the risk of contamination? Is the facility equipped with the right manufacturing platform? If you want the company to also do the stability studies, temperature controlled storage areas should generally be available at -80°C, -20°C, 5°C and room temperature, with dedicated space for Drug Substance and Drug Product stability testing. Another important aspect to watch for is audits of the facility by authorities as well as other customers. If the facility is regularly audited by various types of organizations and has never received any critical or major observations, this indicates that they maintain high quality standards.
It is advised to check whether the CDMO company has successfully manufactured and released products for clinical trials both in Europe and USA. A successful track record for GMP manufacturing and release of clinical products is witnessed by successful IND and/or IMPD dossier submissions.
Batavia Biosciences offers a broad range of clinical GMP manufacturing services for all major classes of biopharmaceuticals, i.e., viral vaccines, viral vectors, recombinant proteins and antibodies. As a company dedicated to help bringing biopharmaceuticals to the market at higher speed, with reduced costs, and with a higher success rate, Batavia Biosciences has vast experience in process development and GMP manufacturing. With our team of experienced scientists and technicians, we are well equipped to take on any challenge associated with clinical GMP manufacturing.