This week, SpeakPharma interviews Fu
Qiang, Deputy General Manager of Shandong Topscience Biotech, one of China’s leading producers of sterile sodium
hyaluronate. Fu discusses the company’s focus
on pharmaceutical and high-end applications, the intricacies of aseptic
production, and the promising future of the sodium hyaluronate market.
🔑 HIGHLIGHTS// leading producers of sterile sodium hyaluronate/ focus on pharmaceutical and high-end applications
China is a major player in the global biotechnology industry. How is Topscience Biotech positioned to compete in this dynamic market?
Shandong Topscience Biotech was founded in 2005 and entered the hyaluronic acid industry in 2008. With a history of 16 years in this market, sometimes called a “red ocean” by industry insiders because of the intense competition, Topscience Biotech has carved a distinctive niche for itself within the highly competitive Chinese biotechnology landscape.
The sodium hyaluronate market doesn’t have a long development history, nor is it monopolized. There are many “players” in the market. But most of them aren’t technically very strong. They are primarily focused on low-tier applications in food and cosmetics and have no means or ability to achieve high-quality, high-tech products.
In contrast, Topscience Biotech has decisively
adopted a strategic approach by avoiding the over-competitive, low-end market
and focusing on pharmaceutical and high-end application fields with higher
technical barriers and fewer competitors.
Sodium hyaluronate is currently one of the company’s core products, encompassing food grade, cosmetic grade, medical device grade, and pharmaceutical grade variants. Globally, there are only a handful of companies in the pharmaceutical sector capable of producing pharmaceutical grade sodium hyaluronate, with an even smaller number based in China.
We are among the five or six companies competing
on the global stage. We have created a competitive barrier by concentrating on
the pharmaceutical grade field, which demands higher technical expertise, and
by leveraging our aseptic production technology.
🔑 HIGHLIGHTS// avoiding the over-competitive low-end market/ leveraging aseptic production technology/ created a competitive barrier
Topscience Biotech is known for its commitment to quality standards. Can you talk about the company's approach to maintaining the highest quality control measures?
Topscience Biotech’s reputation for quality is foundational to its success. A crucial aspect of Topscience Biotech’s quality strategy is its mastery of aseptic production technology for pharmaceutical grade sodium hyaluronate, a field in which it is a leading Chinese company. This strategy enables us to avoid price competition and sustain our market dominance.
Our approach is in harmony with the national
industrial development objectives. It fosters advancements in new quality
productivity.
We invested significantly in building a robust
quality management system that encompasses every stage of the production
process, from raw material sourcing and production to final product release.
The production of sterile sodium hyaluronate imposes exceptionally high
standards on the entire production environment and process flow. Aseptic
production, particularly the later purification stages, necessitates stringent
control over impurities and endotoxins and demands an exceptionally clean
production environment.
The construction of the entire system, including personnel, equipment, material management, document control, clean control, and other aspects, is subject to rigorous standards. This is a systematic undertaking. To realize this vision, we engaged a professional organization to design the workshop interior and collaborated with expert manufacturers on research. The resulting system was meticulously designed to optimize the production process. It’s important to note that the investment in this specialized production line far surpasses that of conventional ones.
🔑 HIGHLIGHTS// robust quality management system/ stringent control over impurities and endotoxins
Can you elaborate on the specific advantages of STERILEHYA, compared to other sodium hyaluronate products available in the market?
The advantage of sterile sodium hyaluronate,
such as STERILEHYA, lies not only in the control of the process and aseptic
production but also in the fact that it provides new possibilities for product
development downstream. Unlike traditional non-sterile sodium hyaluronate,
which requires subsequent sterilization, aseptic preparation is the initial
step in our production process.
Sodium hyaluronate is sensitive to high
temperatures, which can cause it to break down. This presents a challenge for
those requiring sterile materials. STERILEHYA offers a solution by providing
pre-sterilized sodium hyaluronate, eliminating the need for customers to
perform their own sterilization processes. This not only saves time but also
reduces experimental costs and avoids the risk of degradation during
sterilization.
STERILEHYA is particularly useful for sterile
medicinal products and medical devices that cannot undergo final container
sterilization, as it can be incorporated directly into these products without
further sterilization steps. This technology has gained widespread recognition
in the international market, particularly within ophthalmic surgery and
injection applications. As the domestic pharmaceutical industry continues to
advance, the demand for sterile sodium hyaluronate, such as STERILEHYA, is
steadily increasing within the Chinese market.
🔑 HIGHLIGHTS// new possibilities for product development downstream/ saves time and reduces experimental costs/ ophthalmic surgery and injection applications
Biotechnology research is fast-paced. Can you elaborate on Topscience Biotech’s specific strategies for staying ahead of the curve?
Topscience Biotech’s core competitiveness stems from its continuous technological innovation, driven by a formidable team of technical experts dedicated to new product development. It has persistently expanded its product line with a spirit of excellence and innovation.
Our R&D team has a deep understanding of the properties of sodium hyaluronate and continuously explores its potential interactions with other chemical substances.
In recent years, we have introduced a series of sodium hyaluronate derivatives to the market, such as sodium acetylated hyaluronate and zinc hydrolyzed hyaluronate, which are now being used by well-known multinational companies
Besides this, we have made significant investments in R&D to expand our product line beyond sodium hyaluronate, such as chondroitin sulfate sodium and alpha-arbutin. This diversification demonstrates the company’s commitment to exploring new opportunities within the biotechnology sector.
Facing a complex and changing market environment, Topscience Biotech has chosen to stick to its development strategy. We focus on making raw materials, making them refined and specialized, better serving customers, and empowering them to do what they want to do. From food grade to cosmetics grade, medical device grade, pharmaceutical grade, and then to sterile grade, Topscience Biotech’s product line continues to extend to the high-end, confirming the growth logic of “specialized and new” enterprises.
The company boasts of a robust R&D team comprising numerous doctors, with over 40 employees holding intermediate professional titles or higher, all committed to innovation. To foster a synergistic research environment, Topscience Biotech has forged strong industry-university-research collaborations with renowned institutions such as Jiangnan University and Shandong University.
🔑 HIGHLIGHTS// formidable team of technical experts/ expand product line beyond sodium hyaluronate
What are some of the most exciting opportunities you see for Topscience in the coming years?
We maintain a cautiously optimistic outlook on the future of the sodium hyaluronate industry. Opportunities and challenges coexist. While the sector currently faces certain policy and market challenges, the long-term trajectory is promising, driven by increasing market demand and technological advancements.
The aging population, with its growing need for
orthopedic and ophthalmic care, presents a broad market opportunity for sodium
hyaluronate products.
Beyond this, the burgeoning medical beauty
market offers immense potential for sodium hyaluronate-based products. More and
more consumers are beginning to pay attention to the quality and safety of
medical beauty products, for which sodium hyaluronate is a critical ingredient.
This trend creates significant growth prospects
for high-quality raw material suppliers, like Topscience Biotech. Our
technological edge and robust supply capacity have positioned us as a preferred
partner for numerous medical beauty companies in the high-end market.
In today’s uncertain global economy, companies like Topscience Biotech, specializing in niche markets and driving innovation, offer invaluable models for China’s manufacturing sector to emulate.
Topscience Biotech remains an irreplaceable component of the international industrial chain due to its inherent advantages. It is imperative that we optimize our role within this chain to elevate and expand our industry’s influence.
We anticipate continued breakthroughs from
Topscience Biotech, bringing more surprises and disruption to the
pharmaceutical industry.
🔑 HIGHLIGHTS// aging population with growing need for orthopedic and ophthalmic care/ broad market opportunity for sodium hyaluronate products/ burgeoning medical beauty market/ technological edge and robust supply
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