Homegrown Biopharma Craftsmanship: Choosing Quality Over Price War

“In fact, the approach to biopharmaceutical process solutions in China still has a significant gap from know-how.” During the conversation with 17Talk, Huang Yu, the Deputy General Manager of Pharmac, was candid from the very beginning.

Before joining Pharmac in 2021, Huang Yu had been engaged in the biopharmaceutical and fermentation process industry for over twenty years. After leaving an international leading equipment manufacturing company, Huang Yu held positions in several leading domestic bioprocess companies, but mostly for no more than a year. "Many companies' technical teams do not truly think and solve problems within the entire biopharmaceutical process system."

This statement stems from Huang Yu's experience as a frontline manager, process engineer, and project manager in biopharmaceutical and equipment manufacturing enterprises, accompanying and witnessing the growth and development of domestic biopharmaceutical processes and engineering capabilities.

"Twenty years ago, when foreign enterprises first entered China, the concept of fluid process had not yet been established domestically, and the technical barriers were extremely high. At that time, a weld joint (connecting two pieces to be welded into a whole) cost 800 yuan, but now it only costs 80 yuan," Huang Yu recalls. At that time, the domestic system process design was not very rigorous, and some dead corners in design, as well as risk control in aseptic operations and cross-contamination, were also very 'superficial.'

In 2011, the "Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010)" (New Edition of Pharmaceutical GMP), which had been revised for five years and solicited public opinions twice, was officially released. The document stipulates that from March 1, 2021, new pharmaceutical factories must be executed according to the new standards. "The 1998 edition of GMP was only about 100 pages long and did not have detailed guidance," Huang Yu said. At that stage, domestic GMP inspections mainly focused on "looking at documents," that is, checking whether the process operations and equipment SOPs met the established standards. At that time, Huang Yu was a "small team leader" in a vaccine factory, and the on-site inspections he dealt with were probably just a tour of the workshop, and then entering the office to ask questions according to SOP. Basically, they could pass as long as there were no major omissions.

After the 2010 edition of GMP standards was introduced, the industry began to truly enter a significant development phase, and the importance of quality control in the pharmaceutical process gradually became recognized. This is an important step for pharmaceutical process production to move from "disorder" to "knowing what."

Before the "union" of Pharmac and Haoxin, Pharmac's main business was focused on services in automatic control and GMP verification, establishing cooperation with domestic and foreign pharmaceutical companies, and providing them with verification consulting services such as FDA, EMA, and WHO. "This has created a profound understanding of industry standards for Pharmac," Huang Yu introduced, "Relying on the experience accumulated from consulting services, Pharmac uses stricter foreign regulations and standards to guide its own production and control the manufacturing process. It extends its role to Pharmac's customers, helping them better pass international standard audits such as FDA, EMA, and WHO."

Huang Yu has repeatedly mentioned that "manufacturing" is Pharmac's strength. It is reported that before the merger, Guangzhou Haoxin's main business was pressure vessel processing and mechanical manufacturing. The industry's evaluation of it is that Guangzhou Haoxin's product quality is very good, and the products sold more than ten years ago are still running normally.

From various aspects, the acquisition of Haoxin by Pharmac has brought a win-win situation where 1+1>2. Haoxin's business just matches Pharmac's plan, and the pharmaceutical modularization and digital strategy can be synergized. At the same time, thanks to the profound heritage of Pharmac's parent company, Pnc Process Systems Co.,Ltd., unlike many biopharmaceutical process companies that are "involved in price" in the dimension of price, Pharmac has always emphasized and practiced "High Cost-Effectiveness." This is also the reason why Huang Yu joined Pharmac, "The team's philosophy is consistent, we want to solve the real problems that will be faced in the process, and provide some practical value to the industry."

Huang Yu said bluntly that if he encounters businesses that do not pay much attention to pharmaceutical processes, only pursue "just good enough," and pursue the lower the price, the better, Pharmac will not participate. Doing low-price projects, the team will always consider "reducing configuration" in the solution, and it will not get better accumulation and growth, and will fall into meaningless internal friction and competition.

As he said, when you open the list of Pharmac's partners, you will find that AbbVie, Roche, Sanofi, GSK and other TOP MNCs, as well as domestic first-tier Biotech such as Jun Shi, Henlius, Bibo, and Yangshengtang are all prominently listed.

"Specifically, we focus on the durability, operability, maintainability, and sustainable development of equipment in the design and manufacturing end," Huang Yu introduced, "With the expansion of large-scale production, costs will continue to decrease." In terms of process design, including the optimization of SIP and CIP systems, the combination of production scheduling cycles and production processes, Pharmac can improve the equipment utilization efficiency of enterprises to the best level, which is equivalent to reducing operating costs.

It is reported that the core members of the Pharmac team have more than 20 years of experience in fluid engineering design and implementation. This has created a "specialist" full-process guidance and detailed communication for different projects for Pharmac. In this regard, Huang Yu said that a team with only chemical engineering and mechanical theory background cannot do this well, it must understand biology, in order to have a deep understanding of "why the customer wants to do this," and after understanding, it can output a truly operable solution based on the customer's essential needs.

In fact, although the concept of biopharmaceutical process EPC (Engineering Procurement Construction) has been discussed for more than ten years, China is still on the way from "knowing what" to "knowing why" from regulation to design and production.

It is precisely because there is a group of people who are pursuing "knowing why" that Huang Yu can confidently answer - the core competitiveness of Pharmac is to take the process as the lead, and do engineering follow-up (including calculation, design, selection, and other capabilities).

Therefore, Pharmac has accumulated a series of industry-leading implementation experience and exemplary projects in the fields of large molecule biopharmaceuticals and high-activity products, especially in monoclonal antibodies, human and animal vaccines, blood products, insulin, cell therapy, gene therapy, and other fields.