What is the production capacity of China's antibody drugs? Can the situation of key equipment and materials be broken by import?

In recent years, China's antibody drug commercialization production capacity has made considerable progress, but the overall production capacity is insufficient, the production capacity is scattered, the process experience is lacking, the core equipment and materials have not been localized, and the production talent echelon has not yet formed.

The scale of mammalian cell culture directly determines the production capacity of antibodies, and affects the cost and profitability of antibody products on the market.

The main force in the production of antibody drugs in China can be divided into two categories.

01 Production capacity only accounts for 5.

Statistics on China's mammalian cell culture capacity as of 2018:

From the perspective of global production capacity distribution, the global production capacity of biopharmaceuticals (including antibodies, vaccines, insulin, etc.

Geographical distribution of global biopharmaceutical production capacity in 2018:

The overall production capacity of China's antibody drugs is insufficient and the production capacity is scattered.

02 Key equipment and materials rely on imports

At present, the core equipment and key materials for large-scale commercial production in China still need to be imported, and localization has not yet been achieved.

Take the downstream purification process of antibody drugs as an example.

The downstream purification process of antibody drugs is abbreviated as "three columns, two membranes".

However, the downstream purification process of Chinese antibody drugs needs to be further accumulated.

The main manufacturers of protein A fillers and the countries where the companies are located:

03 Lack of talents and third-party organizations

The production process of antibody drugs requires comprehensive application of professional knowledge and skills in multiple disciplines.

The lack of high-quality talent pool greatly limits the development potential of large-scale commercial production of antibody drugs in China.

First of all, antibody drug production has high requirements for process control capabilities.

At present, China's antibody drug industry still lacks a talent pool with strong production process control capabilities.

Secondly, the production of antibody drugs urgently needs the deployment and application of large-scale bioreactors, which will create an urgent demand for talents with large-scale bioreactor application knowledge and management capabilities.

However, China currently lacks a pool of senior talents with extensive experience in the theory and operation of large-scale reactors.
This also indirectly leads to some local antibody drug companies still relying on overseas companies for production.
In the long run, this will be detrimental to the improvement of the large-scale commercial production capacity of China's antibody drug industry.

In addition, China's antibody drug industry lacks strong support institutions such as virus removal or inactivation verification, which also limits the improvement of China's antibody drug industry commercialized large-scale production capacity.

As mentioned above, in order to ensure drug safety and prevent foreign virus contamination, drug regulatory agencies in various countries require data verification of the actual effect of virus removal/inactivation in the purification process.
There are three ways to carry out virus removal or inactivation verification research: enterprise self-verification, third-party verification, and verification by the China Inspection Institute.
Limited by the high cost and operational difficulty of enterprise self-verification, most biopharmaceutical companies mainly submit to the China National Inspection Institute or third-party institutions for virus removal and inactivation verification.

At present, although the number of virus removal or inactivation verification agencies in China is small, the quality of the test results is poor, resulting in insufficient authority and poor generality of the results, which affects the progress of regular production and has become a major issue in the large-scale production of antibody drugs.
Hinder.

This article is excerpted from the launch of the Drug Safety Cooperation Alliance, Ai Kunwei China (