Q: What are the advantages of Tofflon compared with domestic media brands?

A:1. Tofflon Bio-reagent medium products rely on Tofflon Group, and provide integrated solution services with equipment and consumables. 2. Medium related research and development and production work, for medium research and development, the company has reached cooperation with a number of experts, there is a professional technical expert team; 3, the medium product (CHO\HEK293) has been the DMF record of FDA, can better cooperate with customers to do the work of biological drugs declaration; 4. Professional technical service team provides customers with technical support services from culture medium screening to commercial mass production, including culture medium and equipment involved in cell culture process.

Q: Culture medium product development and commercialization process?

A: Product commercialization is strictly in accordance with the process, from the research and development stage, to the small trial stage (i.e., the trial production stage), to the pilot production stage, and finally to the industrial scale into the market sales.

Q: Culture medium production environment?

A: The factory adopts GMP standard and produces according to cGMP regulations. Dry powder medium was produced under D grade environment, and liquid medium was produced under C+A condition.

Q: Are the manufacturing and quality standards for reagents used in cellular and genetic technology in accordance with GMP environmental conditions and manufacturing processes?

A: The production and quality standards of reagent products for cell and gene technology refer to the pharmacopoeia and GMP related specifications, and are manufactured under GMP grade environmental conditions and using safer disposable technology.

Q: Production technology and capacity of medium dry powder?

A: The use of international leading needle grinding equipment, continuous needle grinding production process, to solve the domestic original production process (ball grinding, hammer grinding) efficiency, heat generation and other problems, a batch of maximum 2600KG.

Q: R&D team size and R&D content?

A: Our team is divided into R & D and development, the R & D work is according to customer and market demand on the formula research, the process will be supported by a professional technical expert team; The development will conduct cell culture exploration and verification for new formula products, including shaking bottles to small test, pilot test and industrial mass production.

Q: How stable is the culture medium from batch to batch? How is it controlled?

A: Batch stability, small difference between batches; Strict control of raw materials, production process and quality control direction, use verified and stable raw materials, establish standardized production and quality system documents, implement standardized production and quality control operations, etc., to control batch stability.

Q: What is the product qualification of the current culture medium? Does it comply with the listing declaration? Can you provide all the required materials?

A: At present, media products are managed as first-class medical devices in China. Our production and quality of products comply with ISO13485 and cGMP standards. Currently, I am doing the filing of a class of medical devices, such as FDA MDF, which can support the marketing application and provide document support as required.

Q: Quality control standards and specific test items for medium?

A: Quality control standards In accordance with the requirements of medium products and with reference to GMP and pharmacopoeia

Dry medium: PH, appearance characteristics, microbial limit (aerobic ≤200cfu/g, mold, yeast ≤50cfu/g) solubility, osmotic pressure, particle size analysis, etc.

Liquid medium: PH, appearance, endotoxin (< 10EU/ml), turbidity, osmotic pressure, sterility.

Q: Does the culture medium product production and quality system have a mature management and documentation system, and can it provide online or on-site audits?

A: We have a mature production and quality management system, which can be audited.

Q: What is serum-free animal-derived component medium? Protein free media and defined chemical media? Which category does our medium formulation fall into?

A: Serum-free animal-component free medium is a serum-free medium without any animal-derived components, but with the possible addition of plant or recombinant proteins. Protein Free midium (PFM) : Medium containing no protein, whether plant or animal. Chemical defined medium (CDM): refers to the clear composition of the medium, which also does not contain protein, and does not add plant hydrolysates, but uses some small molecular compounds with known structure and function, such as short peptides. This medium is more conducive to the analysis of cell secretion products and product purification.

Our medium product formulation can provide serum-free and fully chemically defined medium products according to different needs, mainly commercial medium with chemically defined composition.

Q: For the overall solution of the reagent, can we provide technical support such as related process and support customized development?

A: Biological reagents in addition to the development, production and sales of media products, but also with process support and technical services; It can undertake customized development services of culture medium (periodically).

Q: Can you provide a test? How much is the general test sample available?

A: Can provide small batch samples for testing, liquid 1~2L, dry powder about 10L.

Q: Medium replacement method, how to apply the new medium?

A: Generally, there are two methods: ① direct acclimation: general cells can be directly acclimated in new medium for three consecutive generations, and the cell viability can reach more than 95%; ② Gradient acclimation, according to the fresh medium: conditioned medium (9:1)/(5:5)/(1:9)/(0:10) until the medium is completely replaced, the cell viability can reach more than 95%.

Q: During the service cycle of the product, will the purchased product be discontinued or removed from the shelf?

A: Relying on Tofflon Group, the company is an important part of the overall solution. The company has enough support to make products. In addition, the company will provide products if customers need them for a long time according to the contract.

Q: Does the cell preservation solution series for cell and genetic technology meet serum-free requirements, basic formula ingredients, and cell type adaptation? Is there a registration certificate and a Registration Certificate scheme?

A: All the cell preservation solution series products are serum-free formulations, and all of them are chemically defined formula except MCP CryoSPR-DHQ 10(A). The basic formulations are DMSO, sugar, inorganic salt, etc.

The registration and certification is under application. The plan is to first make the domestic first-class medical device record, and then apply for pharmaceutical excipients, foreign FDA master file number, 510K and other relevant certification.

Q: How should newly prepared liquid media be stored? How long will it last?                                                                                      

A: We suggest that the newly prepared medium should be stored at 2~8℃ and kept away from light. When used within a week, it can be valid for one year unopened.

Q: How often is the product updated?

A: The products will be updated according to the needs of customers and the market, and the frequency of complete replacement is about 3-5 years.

Q: What are the differences between the two NK cell serum-free media kits?

A: NK can be divided into KIT01 and KIT02 kits, in which KIT01 adopts complete recombinant protein formula; KIT02 uses clinical grade human derived human blood albumin. KIT01 costs more and has better security. KIT02 is more cost-effective and meets the requirements of current cell therapy product development and application.

Q: What are the advantages of the NK cell serum-free medium kit? Data comparison? Comparing brands?

A: NK KIT is completely serum-free and provides two alternative systems, recombination and non-recombination, with basically the same effect. NK14 days and 21 days amplification can reach 100 times and 400 times, purity of about 80%; Using pure factor system, without feeder layer cells, safer. Against Japanese NK technology products.