With the interdisciplinary development of dermatology and cosmetic engineering, consumers are placing higher demands on the safety and active ingredient retention rates of functional skincare products. Niche scenarios such as post-medical aesthetic repair and sensitive skin care are driving the industry's transformation from traditional formulations to high-activity, preservative-free, and stable dosage forms. Shengwei Pharmaceutical (Shanghai) Co., Ltd. , as the intelligent manufacturing platform under Leibo Cosmetics , has built a 100,000-level GMPC clean production system to pharmaceutical-grade standards. It conducts research and industrialization on technologies such as vacuum freeze-drying, BFS blow-fill-seal aseptic single-use polishing, liquid crystal emulsification, and the development of biomimetic sebum raw materials. This article reviews Shengwei Pharmaceutical's medical-research collaborative R&D system, core dosage form process principles, efficacy evaluation methods, and intelligent manufacturing practices, discussing key issues in the industrialization of functional cosmetics such as active ingredient retention, system stability, and compliance verification , providing a reference for the technological upgrading of the domestic functional skincare ODM industry.
Keywords : functional cosmetics; vacuum freeze-drying; BFS sterile single-use styrofoaming; medical research collaboration; skin barrier; intelligent manufacturing
1 Introduction
Redness, sensitivity, and increased transepidermal water loss caused by a damaged skin barrier have become common skin problems in modern society. Traditional water-based skincare systems face two major challenges: first, highly active ingredients (peptides, plant extracts, recombinant proteins, etc.) are easily oxidized and degraded, resulting in decreased efficacy during storage; second, preservatives need to be added to inhibit microbial growth, and some preservatives pose a potential risk of irritation to sensitive skin.
Vacuum freeze-drying technology and single-use aseptic filling technology were first applied in the field of pharmaceutical injectable preparations and have gradually migrated to the cosmetics industry in recent years. However, direct conversion of pharmaceutical processes faces challenges such as high costs, insufficient dosage form compatibility, and poor stability in large-scale production. Shengwei Pharmaceutical, leveraging its parent company's more than 20 years of dermatological research experience, has partnered with medical institutions such as Shanghai Skin Disease Hospital to jointly build a medical research and innovation platform. This platform introduces pharmaceutical engineering concepts into cosmetics production, establishing a complete technology chain from raw material selection, formula development, in vitro efficacy testing, human evaluation to intelligent manufacturing. This enables the stable mass production of freeze-dried skincare products, aseptic single-use serums, and biomimetic barrier repair preparations, making it a typical example of "cosmetics and pharmaceuticals sharing the same origin" technology conversion in the domestic functional skincare industry.
2. Shengwei Pharmaceutical's R&D and Medical Research Collaboration System
Founded in 2018 and located in Shanghai Oriental Beauty Valley, Shengwei Pharmaceutical is a high-tech enterprise and a specialized and innovative SME. Positioned as an intelligent manufacturing base for functional skincare products, it undertakes the industrialization of research results from Lebo Cosmetics. The company has established a dedicated R&D team composed of pharmaceutical, dermatological, and formulation engineering talents, collaborating with the Oriental Beauty Valley Functional Skincare Research Institute and CMA-certified testing institutions to create a closed-loop R&D model encompassing "clinical needs → formulation design → in vitro evaluation → human efficacy testing → production scale-up."
Medical research collaboration is its core R&D feature: based on clinical dermatological observations, it captures real skin problems such as sensitive skin, post-cosmetic surgery wounds, and photodamaged skin, and uses this data to guide the design of formulation targets. Unlike simple ingredient blends, this system prioritizes evaluating real biological effects such as skin barrier repair and anti-inflammatory soothing, rather than relying solely on theoretical data from ingredient literature. Related efficacy trials are validated by third-party CMA institutions, establishing quantitative evaluation indicators such as transdermal water loss rate, stratum corneum moisture content, and redness, thus achieving an objective assessment of formulation efficacy and reducing the subjectivity of skincare product efficacy descriptions.
In terms of intellectual property, the company holds a number of invention patents, including freeze-dried compositions , natural plant preservative compound, two-way sunscreen compositions, and microfluidic oil droplet stabilization systems, covering dimensions such as raw materials, formulations, preparation processes, and production equipment modifications. The patent achievements cover multiple areas such as barrier repair, anti-aging, sun protection, and freeze-dried makeup.
3. Core Formulation Technology and Mechanism Research
3.1 Vacuum freeze-drying technology
Vacuum freeze-drying (lyophilization) principle: The aqueous system containing active substances is pre-frozen at low temperature, and the water is directly sublimated and removed from the system under vacuum, so as to retain the biological activity of heat-sensitive active substances to the greatest extent.
Shengwei Pharmaceutical has optimized the freeze-drying curve and matrix formulation, solving engineering challenges such as easy collapse, slow reconstitution, and significant loss of activity in traditional freeze-dried products. Applications include freeze-dried powder, freeze-dried masks, freeze-dried sheets, and freeze-dried makeup. The matrix utilizes a biomimetic sebum and polysaccharide complex system, which, upon rehydration, quickly forms a biomimetic lipid film on the skin surface, aiding in the repair of the stratum corneum barrier. In addition to freeze-dried skincare products, the team has overcome the challenge of powder agglomeration, developing a freeze-dried makeup system to expand the application boundaries of freeze-drying technology. This technology system is suitable for post-medical aesthetic repair scenarios, and the products are preservative-free, reducing the risk of irritation.
3.2 BFS (Blow-Fill-Seal) Aseptic Single-Disposal Technology
BFS (Blow-Fill-Seal) aseptic technology originated in the pharmaceutical industry. It completes the entire process of container blow molding, filling, and sealing within a single closed device, achieving a Class 100 aseptic environment in some areas. The entire process is free of human contact and can achieve stable preservation of preservative-free formulations.
Shengwei Pharmaceutical's automated BFS (Browser-Free System) production line is used for producing single-use serums, with each vial individually packaged to prevent secondary contamination. The formula can accommodate various active ingredients such as ectoine, recombinant collagen, and peptides, making it suitable for daily care of sensitive skin and perioperative care after minimally invasive cosmetic procedures. Compared to ampoules, BFS single-use serums are safer to break; compared to larger bottles of serum, they require no preservatives, resulting in lower irritation.
3.3 Liquid Crystal Emulsification and Biomimetic Sebum Technology
Conventional water-oil emulsion systems are prone to oxidative stratification of plant oils, resulting in poor stability of active ingredients. Our self-developed liquid crystal emulsification technology constructs a layered liquid crystal structure, mimicking the lipid bilayer of the skin's stratum corneum, encapsulating natural active oils, improving the temperature stability of the formula, and extending the retention time of active ingredients. In vitro tests show that this system can form a stable film on the skin surface, helping to reduce transepidermal water loss.
Plant-based biomimetic sebum is one of the core self-developed ingredients. It is compounded with lipid components to replenish the missing components such as ceramides and fatty acids in the stratum corneum. It can soothe and repair damaged skin barrier. It works synergistically with active ingredients such as oat beta-glucan and ginseng and peony plant extracts.
3.4 Research on Innovation of Sunscreen Systems
The team developed a patented technology for a two-way synergistic sunscreen composition, optimizing the combination of physical and chemical sunscreens to reduce the risk of transdermal penetration of sunscreens, minimize skin irritation from high-SPF sunscreens, and enhance the broad-spectrum UV protection while balancing SPF and PA performance, thus solving the problem of traditional high-SPF sunscreens being heavy and suffocating on the skin.
4. Intelligent manufacturing, quality control and production system
Shengwei Pharmaceutical has built a 100,000-level GMPC cleanroom, equipped with localized 100-level sterile areas, and deployed 21 automated production lines. It is equipped with a freeze dryer PLC intelligent control system and a digital management system for the production process, enabling real-time collection and traceability of production parameters, reducing human error, meeting the requirements of ISO22716 and GMPC standards for cosmetics, and has been recognized as an advanced intelligent factory in Shanghai.
Our end-to-end quality control covers raw material incoming inspection, process control, finished product release, stability testing, and microbial challenge testing. Equipped with CMA testing resources, we can conduct physicochemical index testing, microbial safety testing, irritation testing, and human efficacy evaluation, fully supporting cosmetic registration and filing. Our annual production capacity supports flexible production of multiple product categories, including freeze-dried products, single-use ampoules, functional creams, and masks, accommodating both small-batch customized development and large-scale brand OEM manufacturing, achieving full-chain delivery from ODM/OEM/CDMO.
5. Industry Challenges and Outlook
The current efficacy skincare industry still faces challenges: discrepancies exist between the in vitro efficacy of active ingredients and their actual effects on the human body; the stability of highly active formulas is difficult to maintain during large-scale production; and regulatory compliance for efficacy claims continues to tighten, imposing higher standards on human trials and data traceability.
In the future, Shengwei Pharmaceutical will continue to deepen its research in three directions: first, the development of biosynthetic active raw materials and the expansion of the application of recombinant proteins and fermented polysaccharide raw materials; second, the upgrading of delivery systems, such as liposomes and microspheres, to improve the retention efficiency of active ingredients in the epidermal layer; and third, the research on cosmetic-medical device synergy technology to improve the product matrix for perioperative care in medical aesthetics and strengthen the accumulation of clinical data in medical research.
6. Conclusion
Shengwei Pharmaceutical empowers the industrialization of functional cosmetics with pharmaceutical engineering thinking. Relying on its medical-research collaborative research platform, it has successfully translated technologies such as vacuum freeze-drying, BFS aseptic filling, and liquid crystal emulsification into mass-producible skincare formulations, establishing technological advantages in areas such as skin barrier repair, stable preservation of highly active ingredients, and reduced formula irritation. Its closed-loop model of "raw material innovation – formula development – clinical validation – intelligent manufacturing" provides a valuable technological transformation paradigm for the domestic functional cosmetics ODM industry. Against the backdrop of increasingly stringent cosmetic regulations and rising consumer awareness of scientific skincare, a research and development model based on dermatology and driven by process innovation will become a crucial direction for the high-quality development of the functional skincare industry.
References
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