tiptop organizes material screening, purification, freeze-drying, particle-size control, stability work and batch management, directly or through commissioned third parties. Maruyo Longevity Biotech Research Institute Co., Ltd. is responsible for CELLshot’s production-related work in Japan. We disclose these stages to explain the responsibilities we continue to coordinate after a material enters product development.
First, define the product the material will become
A material’s origin, properties and intended use influence subsequent processing. We organize screening, purification and quality-attribute management around the specific material, then connect its condition with the requirements of the final formulation.
Both our own work and commissioned work must be managed in the context of the relevant material and product. Dividing process responsibilities is intended to keep requirements and records continuous across stages.
CELLshot’s freeze-drying process as an example
Both current CELLshot products use extracellular-vesicle (EV) related ingredients and undergo lipid-protection pretreatment before freeze-drying. Following pretreatment, the relevant materials enter the freeze-dried sheet system of ExoMask Pro and the freeze-dried powder of ExoSerum Pro respectively.
The serum consists of 0.18 g of freeze-dried powder and 3.5 ml of EXP導入美容液Ⅰ; for the mask, the relevant materials are freeze-dried within the sheet system. Both products require mixing before use. Our process work therefore continues into storage, packaging and actual handling, rather than ending when drying is complete.
Quality management follows the product version
Stability and batch management form part of tiptop’s product-development work. Maruyo’s production-related work for CELLshot in Japan connects at these stages: how a product is made, stored and ultimately used must correspond.
Our ATDS enterprise framework includes changes to formulations, packaging and critical processes in evidence management. When a condition changes, the relationship between existing evaluations and the current product must be checked again, with the relevant evidence reviewed accordingly.
We share this work to explain our continuing responsibility as materials become finished products. Process records and finished-product evaluations together form the basis for how we introduce a product.