Problems to be solved in the commercial production of biopharmaceuticals

China's biopharmaceutical industry is booming and its influence is reaching the world.
In the past ten years, the global biopharmaceutical market competitiveness has increased significantly.
China is rising, which will have a profound impact on the future of global biomedicine
.

According to statistics: in 2030, the global biopharmaceutical market space will reach 7680 billion US dollars, the Chinese biopharmaceutical market space will increase to 1,303 billion yuan, and China will account for 25% of the global biopharmaceutical market

Biopharmaceutical technology is different from traditional pharmacy.
In the process of commercial production, especially in the process of capacity expansion, stable production and efficiency improvement are required, and there are still many problems that need to be solved urgently.

01 Engineering design and equipment supporting meet capacity requirements

01 Engineering design and equipment supporting meet capacity requirements

At present, the design of many commercial production lines and supporting projects of biological products still refers to the production lines and engineering design of traditional pharmaceutical sterile products
.

For capacity expansion requirements:

For example, the reactor in the upstream cell culture stage has requirements for engineering weighing and layer height, especially after the expansion of production to increase the scale of fermentation, it needs to be supplemented with corresponding equipment;

In response to regulatory requirements:

With the continuous improvement of biological product regulations, such as physical measures to distinguish between virus-free and virus-free operating areas;

For product characteristics:

In the production of downstream preparations, biological products are non-terminally sterilized products, and some fragile protein preparations require low-temperature filling production requirements, which also poses certain challenges to the production time limit
.

These are all faced with the problem of changes in the layout of the workshop.
In addition to building a new workshop, the reconstruction of the workshop on the existing basis may lead to a situation where the working space is cramped or the layout of various functional areas is not reasonable
.

There are challenges in expanding the capacity of the same product and launching new products online

02 Stable output of production process

02 Stable output of production process

The stable output of the production process depends on many factors, including the batch-to-batch stability of raw and auxiliary materials, the stable operation of equipment, the compliance operation of personnel, the effective handling of abnormal events, the timeliness and accuracy of intermediate products/semi-finished products/finished products detection feedback, etc.
and so on
.

The biopharmaceutical process is different from traditional pharmaceuticals.

03 Timely matching of available biotech talents

03 Timely matching of available biotech talents

In the biological industry, existing high-level talents are not uncommon, but the stable output of drugs is inseparable from the largest number of front-line operators and front-line managers.
Driven by the increasing demand for the commercial production of biological products, Many pharmaceutical technicians and management personnel from traditional medicine have joined the biological industry.
However, due to the temporary lack of biological expertise, the difference in production line operation and control methods, etc.
, the production process of biological products is more dependent on rationality than traditional pharmaceuticals.
The operation and technical level of the personnel used on the actual production line does not meet the needs of commercial production well, and the available technical personnel on the front line face a very large gap
.

04 Timely and effective operation of the supply chain

04 Timely and effective operation of the supply chain

Biopharmaceutical equipment, especially the correct selection of process equipment and production line consumables, reasonable application, timely and sufficient supply, and matching of technical maintenance capabilities, etc.
, also greatly affect the agility of the commercial production of biological products and the selection of technical capabilities.
Suppliers with a solid, complete supply system and reliable operation and maintenance team will also lay a more solid foundation in the later production expansion guarantee
.

In response to the above-mentioned relatively concentrated problems, many domestic and foreign biopharmaceutical companies have also sought countermeasures
.

First of all , in recent years, CRO/CDMO factories in the biological industry have continued to emerge.
This is not only a manifestation of industry demand, but also a manifestation of industry progress.
This form of research and development and production enterprises gather all kinds of high-tech professional and technical personnel.
It can better solve various technical problems of products.
At the same time, because of the variety of products it undertakes, its plant and equipment are flexible, which can ensure the short-term and high-quality delivery of the project.
Therefore, the concept of modular factory has also emerged.
There has been a precedent that a well-known company can create an operational biopharmaceutical plant within 18 months
.

first

Biological product R&D outsourcing has been maturely applied.
In order to reduce the input cost caused by plant renovation or new plant and equipment purchase, increase the production efficiency of existing production lines, and meet the flexible demand of production orders.
In the future, part or even all of the production will be outsourced.
It has gradually become the choice of some technology-oriented enterprises
.

In addition , for the training of biotechnical personnel, local governments and bio-parks have also increased their training within their jurisdictions, and assisted in meeting the labor needs of bio-enterprises
.

The investment in the construction of the supporting biological training base will also provide education guarantee for the stable output of technology for more front-line operators of biological products in the future

in addition

Furthermore , while the production process is relatively stable and controllable, digital and intelligent production concepts and layouts are introduced to strengthen the timely, complete, effective and traceable production process data, reduce uncontrollable factors caused by human operations, and improve deviation investigations Speed ​​and reliability
.

In some cities in the Yangtze River Delta, some companies have networked with regulatory agencies through their internal digital platforms, and the regulators can access relevant data and records in real time.

Furthermore

Finally , looking at foreign and local companies, Samsung Biologics’ super factories and digital quality plans, and the world’s leading CRO/CDMO company WuXi Biologics’ layout and prospects for continuous production, all of them are moving towards agile manufacturing in the commercial production of biopharmaceuticals.
Practice and exploration
.

finally

Summarize

Summarize

The core idea of ​​agile manufacturing is to improve the company's ability to respond quickly to market changes and meet customer needs
.

In addition to making full use of the internal resources of the enterprise, it can also make full use of the resources of other enterprises and even the society to organize production

First of all, as a special commodity, medicine needs materials with clear source and uniform quality, continuous and stable production technology, reliable equipment and facilities guarantee, complete and systematic traceability system, and coordinate and interrelate technology, management and personnel to provide customers with satisfactory products.

.

Focusing on biopharmaceuticals, as a new force in the pharmaceutical industry and a pioneer in the future, technologies and drugs for the prevention, treatment and diagnosis of new and malignant diseases adapted to modern people continue to emerge