Unlike that of traditional pharmaceuticals, the technology of biologic pharmaceuticals needs to stabilize production and improve efficiency in commercial production, especially in the process of capacity expansion. There are still many problems to be solved.
The production line and engineering design of many commercially produced biological products still refer to the production line and engineering design of traditional pharmaceutical sterile products.
(1) Target at capacity expansion demand. For example, the reactor in the upstream cell culture stage has requirements for engineering weighing and storey height. Especially in the production of increased fermentation scale after expansion, we need to supplement the equipment with the corresponding class.
(2) Target at regulatory requirements: with the continuous improvement of regulations on biological products, for example, in terms of physical measures, there are virus-free and virus-free operating areas.
(3) Target at product characteristics: biological products are produced in the downstream preparation end, and biological products are non-terminal sterilized products. Some fragile protein preparations require low-temperature filling for production, which also poses certain challenges to the production time.
All of these are faced with the problem of workshop layout change. In addition to the newly built workshop, the renovation of the workshop on the existing basis may lead to cramped working space or unreasonable layout of various functional areas. There are challenges in expanding the capacity of the same product and launching new products.
The stable output of production technology depends on many factors, including batch stability of raw and auxiliary materials, stable operation of equipment, personnel compliance operation, effective handling of abnormal events, timely and accurate feedback of intermediate/semi-finished/finished product testing, etc. Biologic pharmaceuticals technology is different from that of traditional pharmaceuticals. The raw materials of biologic pharmaceuticals are mainly natural biological materials. In short, biologic pharmaceuticals technology is a method that uses living organisms to produce drugs, such as cells. The test limits, test accuracy and experimental reproducibility of the test methods for process stage results and final results of feedback technology depend on the existing technological regulations, technical capabilities and operator level.
In the biological industry, the existing high-level talents are not rare, but the stable output of drugs cannot be achieved without the largest number of front-line practical operation personnel and front-line management personnel. Driven by the increasing demand for commercial production of biological products, many traditional pharmaceutical technicians and managers have joined the biological industry. However, there are problems such as the temporary lack of biological expertise background, different production line operations and control methods, etc. The operation of the production process of biological products is more dependent on the understanding of its reasoning than traditional pharmaceuticals, and the production technology is not the same between different varieties. As a result, the operation and technical level of the personnel used in the actual production line do not meet the needs of commercial production well, so there is a very large gap in the technical personnel available on the front line.
In terms of biologic pharmaceuticals equipment, especially the correct selection and reasonable application of technological equipment and production line consumables, timely and sufficient supply, matching of technical maintenance ability and other factors, they also greatly affect the promotion of agility in the commercial production and manufacturing of biological products. Suppliers with solid technical ability, perfect supply system and reliable operation and maintenance team are selected to ensure the production capacity expansion and build a stronger foundation in the later stage.
