The New Deal encourages the continuous manufacture of oral solid formulations or creates opportunities upstream

【Pharmaceutical network market analysis】In pharmaceutical preparations, it is particularly common to take oral solid preparations, such as tablets, capsules, etc.
, but at present, the oral solid preparation process is still produced in semi-continuous manufacturing batches, that is, the general process is material pretreatment, mixing, granulation, tableting/filling capsules, coating and packaging, etc.
, there are cumbersome steps, low production efficiency, drug quality problems and other bottlenecks
.

Since 2015, continuous manufacturing (CM) technology has gradually gained popularity in the pharmaceutical industry, and several products have been successfully marketed
.

The New Deal encourages the continuous manufacturing of oral solid preparations, or brings opportunities for the upstream (Picture source: Pharmaceutical Network) In order to modernize the pharmaceutical process, improve the stability of the manufacturing process, reduce product failures and improve product quality, foreign countries, including the FPA, EMA, PDA and other early years, have issued relevant documents to encourage and support continuous manufacturing
.

On September 9, 2022, CDE also issued an announcement to solicit public opinions on the Technical Guidelines for the Continuous Manufacturing of Oral Solid Preparations for Chemical Drugs (Draft for Solicitation of Comments
).

The "Draft for Comments" pointed out that the continuous manufacturing process has many characteristics such as continuous production steps, high production efficiency, small equipment footprint, real-time monitoring of product quality, and easy adjustment of production batches, which is conducive to improving and improving the quality
of drugs.

The Draft for Comments elaborates on the overall considerations, related concepts, control strategies, process verification, stability studies, batch changes, drug quality systems, and declaration data requirements for the continuous manufacturing of oral solid preparations of chemical drugs, and aims to provide guidance
for the research and evaluation of continuous manufacturing technology of oral solid preparations of chemical drugs.

The deadline for comments is 8 October 2022
.

It is worth mentioning that in terms of equipment design and system integration, the Draft for Comments proposes that equipment design and its integration have an impact on
process dynamics, material transportation and conversion, and output material quality.

The applicant needs to reasonably design or select the unit operating equipment and system components to mitigate the impact of disturbances on the quality of the final product, such as the compatibility and integrity of the equipment components, the geometry of the constituent parts, the spatial arrangement of the equipment, the connections between the equipment, the material diversion and the location of the sampling points
.

The industry pointed out that the equipment is actually a major challenge in continuous manufacturing technology, most of the existing conventional equipment is suitable for semi-continuous production process, so the follow-up needs to be supported by equipment suitable for continuous production, at present, especially for continuous manufacturing production of pilot equipment is relatively lacking, urgent need to break through
.

At the same time, in the past, the integration of stand-alone equipment had the problem of inconsistent interfaces between devices, which made the equipment unstable in the process of use, which would also have a certain impact on
the quality of output materials.

The overall solution of pharmaceutical equipment can improve the continuity and data reliability of pharmaceutical production and meet the high requirements
of pharmaceutical production.

The transformation from stand-alone equipment to pharmaceutical equipment overall solution will become a major trend
.

At present, domestic pharmaceutical equipment enterprises that have formed a platform and intelligent technology, such as Chutian Technology and Dongfulong, can provide multi-field overall solutions
.

Among them, Chutian Technology has formed an overall solution in the fields of BFS aseptic dispensing system, intelligent lyophilized preparation system, intelligent pre-filling system, intelligent oral liquid agent system and other fields to achieve the effective integration
of various types of data.

Dongfulong is a comprehensive pharmaceutical equipment service provider that provides global pharmaceutical enterprises with overall solutions for pharmaceutical technology, core equipment and system engineering, and its products are widely used in injections, solid preparations, chemical APIs, biological engineering, traditional Chinese medicine, medical and other fields
.

In addition, the overall solution of Chengyitong Technology's intelligent solid preparation workshop can also help realize the digital overall solution of multiple varieties, processes and multi-dosage forms of oral solid preparations, build a modern and information management data platform for pharmaceutical companies, and realize dust-free, intelligent and information-based production and operation
of the workshop.

According to a research report, the market size of the use of continuous manufacturing approved products in 2018 was $230 million, and it is expected to reach $380 million
by 2024.

From the perspective of CDE's attitude, in the future, the domestic solid oral preparation production may accelerate the transition from semi-continuous manufacturing batch production to continuous manufacturing, in this context, the upstream equipment industry may also usher in new opportunities
.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.