贝融生物羟基磷灰石

BETAGENE Genetic 贝融生物位于上海外高桥，是HerostemLab汇融实验室旗下专注于医美材料与研发的转化与创新孵化平台。我们致力于精品化医美产品的研发与商业授权，现已开发并对外授权多款注射类产品，并成功孵化了PETAL REGEN花瓣生物、SUNERA等公司，推动其独立运营与商业化发展。

贝融生物的产品涵盖特异******联蛋白植入剂、注射用羟基磷灰石-透明质酸钠复合凝胶、多表征羟基磷灰石微球、注射用琼脂糖凝胶等。我们的团队在羟基磷灰石微球的研发与制造领域深耕多年，产品远销海内外多个市场，生产制造质量体系亦已通过多家头部企业的严格审计，具备国际水准的供应链保障能力。

As an innovation and incubation platform under Herostem Lab，BETAGENE Genetic (BETAGENE) is dedicated to medical aesthetic materials and R&D. BETAGENE has successfully developed and out-licensed multiple injectable products, while incubating companies such as PETAL REGEN and SUNERA BIO, driving their independent operation and commercial expansion.

Our portfolio features specifically cross-linked collagen implants, injectable hydroxyapatite composite gels, hydroxyapatite for chromatography and aesthetics, and injectable agarose gels. In particular, our distinguished hydroxyapatite microsphere (CaHA) products are distributed across global and domestic markets. Furthermore, our quality control and manufacturing systems have successfully passed rigorous audits by leading industry enterprises, ensuring supply chain capabilities of international standards.

• 注射用羟基磷灰石（Hydroxyapatite for injection）

• 层析用羟基磷灰石（Hydroxyapatite for chromatography）

 注射用羟基磷灰石

• MPlc型 - 多孔、快速降解、低结晶度

MPlc 型的低结晶特性导致其降解迅速（点击阅读：羟基磷灰石选高结晶还是低结晶？），我们在动物体内观测到 3-6 个月的降解周期，且植入后有明显的炎性刺激-胶原生成现象。上图右（1μm标尺）可明显看到 CaHA 晶体的“团聚”（agglomerate），而非“聚合”（aggregate）。前者的结合力更弱，因此容易被分散开，也因此产生了较多的孔隙。

MPlc 型的 CaHA 微球降解快速，如果用于美容的填充，需要仔细考虑临床评价的终点是否可被满足（点击阅读：Merz审评报告分析｜哪些数据值得关注？）。

The low crystallinity of MPlc CaHA leads to its rapid degradation. We observed a degradation period of 3–6 months in animal models, accompanied by a distinct post-implantation response: inflammatory stimulation followed by collagenogenesis. In the right panel above (1 μm scale), the "agglomeration" rather than "aggregation" of CaHA crystals is clearly visible. The former involves weaker binding forces, making the crystals easier to disperse and thereby creating more intra-particle/inter-particle pores.

Due to its fast degradation rate, when using MPlc CaHA microspheres for aesthetic soft-tissue augmentation, careful consideration must be given to whether the clinical evaluation endpoints can be fulfilled.

SMP CaHA maintain an in vivo persistence exceeding 12 months, making them highly suitable for developing medium- to long-term facial implants. As shown in the right panel above, the crystals have begun to undergo aggregation, forming distinct necking between particles (sintering necks). This results in a "coral-like" micro-porous surface architecture. Notably, microspheres with an excessively high specific surface area are prone to agglomeration driven by zeta potential.

• GS型 - 致密、惰性、长效
  

GS CaHA features a high crystallinity exceeding 95%, approaching full-crystallization. Solid and porous microspheres yield completely different outcomes post-implantation, and variations in surface roughness or smoothness also introduce marked performance differences (Click for more: 【英译】Hydroxyapatite | Solid or Porous?). The crystals are fully aggregated with no detectable porosity.

Similar to commercially available dense solid spheres, GS CaHA microspheres exhibit a non-porous surface structure where CaHA crystals are fully aggregated post-fusion, giving rise to a characteristic "turtle-shell" (tortoise-shell) texture (the formation process is shown above). With a tapped density exceeding 1.8 g/mL, they represent a classic ceramicized microsphere. Utilizing an innovative sintering process, we have successfully maintained the smooth, spherical morphology of the CaHA microspheres, achieving superior flowability.

GS CaHA demonstrates an in vivo persistence exceeding 18 months (with certain studies suggesting 24–36 months or more). Post-implantation, they exhibit exceptional biological inertness and minimal immunogenicity, with virtually no observable inflammation in animal models. Nevertheless, collagenogenesis is still induced, suggesting that the collagen regeneration mechanism for such solid spheres leans toward mechanical stimulation rather than inflammatory response. This makes them exceptionally suitable for developing semi-permanent implants.

GS CaHA gradually degrades under the influence of body fluids, continuously releasing calcium and phosphate ions. Owing to their high density/mass, R&D teams must meticulously select an appropriate gel carrier to prevent microsphere sedimentation and premature aggregation.

• 技术支持
  

 层析用羟基磷灰石

贝融生物生产的层析用羟基磷灰石（BG-CHT）是功能多样的混合模式填料，在生物分离领域，羟基磷灰石具有重要的研究和工业应用价值。 BG-CHT 兼具离子交换和金属亲和力（如下图），具有其他填料不具备的特殊分离能力。

BG-CHT 通过专有工艺研发生产的超纯 10nm×100nm 的六边形截面晶体（如下图）。晶体凝聚成颗粒，然后加热烧结，在晶体接触点形成了稳定的连接。颗粒大小和孔隙率被严格控制，使其颗粒易于装填，最终实现出色的分离性能。

它混合纯化机制可以提供独特的选择性，能够分离其他介质不能分离的各种比较难分离的、性质比较接近的生物分子。BG-CHT 可以用于宿主蛋白(HCP)、脱落的protein A、抗体二聚体及聚合体、核酸及病毒的分离，可以用于捕获、中度纯化或精纯各个纯化阶段。

BG-CHT 分为三个粒径规格：20μm、40μm、60um，以及按照蛋白载量分为三种型号：I 型、II 型、III 型。BG-CHT I 型的蛋白载量比较高，且对酸性蛋白具有更高的载量；BG-CHT II 型载量较 I 型载量低，对核酸及某些蛋白具有更好的分辨率。同时BG-CHT II 型对白蛋白有低的亲和力，更适合纯化各类免疫球蛋白及其亚型。III 型是我们设计出来用于挂在 HCP 的型号。

Chromatography-Grade Hydroxyapatite (BG-CHT), manufactured by BETAGENE, is a versatile mixed-mode chromatography resin with substantial research and industrial applications in bioseparation. Combining both ion exchange and metal affinity mechanisms, BG-CHT delivers unique separation capabilities unmatched by conventional resins. Built upon proprietary processing technologies, BG-CHT consists of ultrapure, hexagonal-cross-section crystals measuring 10nm x 100nm. These individual crystals agglomerate into particles and are subsequently sintered, forming stable interconnecting necks at crystal contact points. Particle size and porosity are tightly controlled to ensure easy packing and exceptional separation performance.

This mixed-mode purification mechanism offers distinct selectivity, enabling the resolution of closely related or difficult-to-separate biomolecules that cannot be resolved using other media. BG-CHT is widely applicable for removing host cell proteins (HCP), leached Protein A, antibody dimers and aggregates, nucleic acids, and viruses across various purification stages—including capture, intermediate purification, and polishing.

BG-CHT is available in three particle size specifications: 20 μm, 40 μm, and 60 μm, and three distinct types based on protein binding capacity: Type I, Type II, and Type III.

• BG-CHT Type I features higher protein dynamic binding capacity, with exceptionally high capacity for acidic proteins.

• BG-CHT Type II offers a relatively lower binding capacity than Type I, but delivers superior resolution for nucleic acids and specific proteins. Additionally, Type II exhibits a low affinity for albumin, making it ideal for the purification of various immunoglobulins and their subclasses.

• BG-CHT Type III is specially engineered for high-efficiency HCP binding and clearance.

• BG-CHT 工作参数

• 技术支持

我们制定了《BG-CHT 使用说明》供客户参阅。使用说明中详细地介绍了关于层析用羟基磷灰石的特性和使用方法。在使用说明没有覆盖到的方面，我们的技术支持团队也会随时待命，与您一同攻克技术难题。

BETAGENE Genetic贝融生物作为Herostem汇融实验室旗下再生医学材料领域的先锋力量，始终深耕于羟基磷灰石、重组蛋白等技术的研发与创新。凭借独特的多规格 CaHA 微球工艺，我们可以对微球的外貌、粒径、孔隙、结晶度精准调控，赋能面部植入剂创新属性。精准塑形到自然融合，提供研发输出全案支持，为您带来更多元的微球产品矩阵。

贝融生物围绕羟基磷灰石微球技术构建了全链条专利壁垒，已申报多篇发明专利和实用新型专利。同时，公司也参与制定了 CaHA 微球的标准，联合科研单位建立相关评价方法的标准制定，为产品合规化与行业高质量发展提供科学标尺。

As a pioneering force in regenerative materials under HEROSTEM®️Lab (汇融实验室), BETAGENE Genetic (BETAGENE®️) remains deeply committed to R&D and innovation in hydroxyapatite, recombinant proteins, and advanced biomanufacturing technologies. Leveraging our proprietary multi-specification CaHA microsphere manufacturing process, we can precisely engineer and fine-tune microsphere morphology, particle size, porosity, and crystallinity - empowering the creation of innovative facial implants. From precise contouring to natural tissue integration, we deliver end-to-end R&D solutions and a versatile portfolio of microsphere products.

BETAGENE®️ has built a robust, end-to-end patent barrier surrounding our hydroxyapatite microsphere technologies, with numerous invention patents and utility model patents filed. Concurrently, we actively contribute to establishing standards for CaHA microspheres and collaborate with research institutions to develop standardized evaluation methodologies, providing scientific benchmarks for product compliance and the high-quality development of the industry.

Currently, BETAGENE®️ has delivered large-scale shipments of GS CaHA microspheres to our global clients, securing repeat orders from key aesthetic R&D partners and passing rigorous quality audits by industry leaders - which represents a clear testament to the trust our customers place in our R&D excellence, product quality, and proven results.