Full process technical support
We have experienced engineers, technical support and after-sales team to speed up the development and production process of more efficient and affordable drugs, benefiting doctors and patients.
Applications
Tofflon has four core divisions: Biotechnology Division, Preparation Equipment Division, Engineering Division and Food Engineering Division. It can provide process equipment, core consumables and technical support for different processes and dosage forms in the development and production of small molecular drugs, macromolecular biological drugs, CGT drugs and APIs. Provide consulting, design, construction, verification, informationization, public works and other services for pharmaceutical plants in the field of pharmaceutical engineering. In the food field, we provide equipment and turnkey engineering services including process technology research and development, engineering design, equipment manufacturing, engineering installation and training services for dairy products, beverages, alcoholic beverages, health products and food additives.
Tofflon is a total solution service provider supplying process services and consumables, core equipment, and engineering for global pharmaceutical companies.
Tofflon continues to strengthen the research of pharmaceutical manufacturing science and pharmaceutical machinery manufacturing science, and strives to build a "next-generation pharmaceutical manufacturing platform" to provide professional solutions for customers in R&D, pilot and commercial production, and help the rapid development and large-scale commercial production of drugs.
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Cell Therapy Solution
In 2010, Emily, a 5-year-old patient with acute lymphoblastic leukemia, received CAR-T cell therapy, and now the disease has not recurred, creating a miracle in treating cancer. The therapeutic effect of cell therapy is constantly affirmed by doctors and patients, which brings new hope for the treatment of patients with advanced cancer. However, due to the particularity of cell therapy drugs, CMC and cost are still huge. How to apply the concepts of QbD and Risk Assessment to process development and production is the core of one-stop scheme. Tofflon can provide flexible solutions for cell therapy drugs from laboratory to large-scale production, with reliable whole station and honeycomb system providing flexible use scenarios and a complete consumable system, which can provide key support from research and development to the implementation of production strategies.
AAV Solution
Adeno-associated virus（AAV）belongs to parvovirus family with low pathogenicity. Adeno-associated virus vector is a gene delivery tool based on AAV genome. It has the advantages of low immunogenicity and site-specific integration ability, and is considered to have good safety. It shows great therapeutic prospects in the treatment of hereditary retinal diseases, spinal muscular atrophy, AADC deficiency and hemophilia, and is considered to be the most promising gene therapy vector. The production steps of AAV mainly include cell culture, virus infection, replication and large-scale culture, virus collection and purification, quality inspection and drug packaging. Tofflon can provide solutions from laboratory to mass production, including adhesion and suspension systems, and develop AAV affinity fillers with advantages, which have successfully assisted R&D and production of many related enterprises, and can provide key support from R&D to commercial implementation.
mRNA Solution
mRNA technology has changed the thinking of treatment, including vaccines. With its advantages in clinical manifestations and production, the treatment based on mRNA technology will give birth to new treatment fields and treatment schemes. However, mRNA-LNP therapy drugs need high delivery efficiency and accurate delivery location, and there are still many challenges in process distance and supervision. How to apply the concepts of QbD and Risk Assessment to process development and production is the core of one-stop plan. Tofflon can provide solutions for mRNA technology and LNP technology from laboratory to mass production, which has successfully helped mRNA enterprises to break through the core production process and go public, and can provide key support from research and development to the implementation of production strategies.
Oncolytic Virus Solution
Oncolytic virus is a kind of tumor-killing virus with replication ability, which can selectively infect tumor cells by using the inactivation or defect of tumor suppressor genes in target cells, replicate in a large number of tumor cells and eventually destroy tumor cells, stimulate immune response at the same time, and attract more immune cells to continue to kill residual tumor cells. Oncolytic virus specifically infects tumor cells and releases virus offspring to induce tumor cell lysis.
Antibody Solution
Monoclonal antibody drugs are highly homogeneous antibodies that only target a specific epitope. Accurate and efficient monoclonal antibody drugs are widely used in the treatment of clinical tumor patients, autoimmune diseases and other fields, and then new treatment methods such as double antibodies and ADC drugs are derived, which are gradually accepted and recognized by the market. Because of its complex molecular structure, biological products are more difficult and challenging than chemical drugs. Tofflon has a very rich industry accumulation in antibody-related fields, has a complete biotechnology system and preparation solutions, and can provide support in engineering, equipment, consumables and process services to help you implement from research and development to commercialization.
ADC Solution
In the field of tumor treatment, antibody-coupled drugs (ADC) can improve the efficacy and specificity of cancer treatment by combining monoclonal antibodies with potent cytotoxic drugs. The core idea is to use the targeting characteristics of antibodies to deliver cytotoxic drugs directly to cancer cells to achieve therapeutic effects. ADC drugs are complex and special, with serious toxicity, and there are many risks and challenges in the production process. Tofflon has rich experience in preparation of monoclonal antibody, drug-loaded coupling, purification and preparation production, and provides information solutions (equipment+engineering+consumables), especially in antibody production, disposable technology, coupling technology, purification technology, operation and preparation of toxic drugs, freeze-drying, etc., which can provide reliable process support and help you implement it from research and development to commercialization.
Vaccine Solution
Vaccination is the most economical and effective public health intervention measure to prevent and control infectious diseases, and it is an effective means to reduce the occurrence of diseases and medical expenses of citizens. However, the development of vaccines is a long and complicated process, with higher production costs and stricter legal requirements. Reliable equipment can ensure the stability and traceability of vaccine products. Tofflon has accumulated rich cases in the preparation, purification, storage and preparation of stock solution for different types of vaccine technology. Provide information cooperation mode (equipment+engineering+consumables), with rich case accumulation, and provide support in engineering, equipment, consumables and process services to help you implement from research and development to commercialization.
Polypeptide Drug Solution
Polypeptide has the advantages of good specificity, outstanding curative effect, high safety, low immunogenicity, good membrane permeability and relatively low cost, and occupies an important position in therapeutic drugs. The synthesis of peptides is still dominated by chemical solid-phase synthesis, supplemented by liquid-phase synthesis. With the development of synthetic biology and genetic engineering, biosynthetic methods have gradually begun to appear in large-scale polypeptide synthesis. For polypeptide drugs, Tofflon can provide polypeptide synthesizer, solid-state synthesis of over kiloliters, fermentation system solutions of over ten thousand liters and bioengineering solutions. It adopts the information cooperation mode of (equipment+engineering+consumables), has rich case accumulation, and can provide support in engineering, equipment, consumables and process services to help you implement from research and development to commercialization
Blood Products Solutions
Blood products are industries with strong qualifications, high thresholds and high requirements, and the whole process of product production is strictly controlled. Products such as albumin, static acrylic acid and coagulation factor VIII play a vital role in medical first aid, war injury rescue and specific diseases. With the increase of product indications, there is a large room for improvement, and the end products keep growing steadily. Tofflon has accumulated rich cases in plasma processing, preparation, purification, storage, preparation and other processes. It can provide (equipment+engineering+consumables) information cooperation mode, provide perfusion culture solutions in the eight-factor process of reorganization, have rich case accumulation, and provide support in engineering, equipment, consumables and process services to help you implement from research and development to commercialization.
Sterile Injection Solution
Injection refers to the sterile solution made of drugs for injection into the body, which is in the form of liquid or freeze-dried powder needle, and refers to the sterile solution (including emulsion and suspension) made of drugs for injection into the body and the sterile powder or concentrated solution prepared into solution or suspension before use. Because it directly enters the blood circulation, injection has higher requirements for the environmental control of clean room (area), the execution of aseptic operation, the use, verification and maintenance of production equipment, the sterilization process of sterile drugs and quality control measures. Tofflon participated in the revision of the 2022 edition of China GMP Guide "Sterile Preparations" and "Factory Facilities and Equipment", and participated in the benchmarking of sterile drugs and PIC/S sterile drugs in China GMP Appendix. Can provide (equipment+engineering+consumables) information solutions, especially in the aspects of liquid preparation technology, filling technology, freeze-drying technology, BFS technology, barrier technology, water technology and so on, and can provide reliable process support to help you implement from research and development to commercialization.
OSD Solution
The development forms of oral solid preparations include granules, dripping pills, capsules or tablets, etc., and the production process is complicated, including a series of complicated processes such as pretreatment of raw materials, mixing, granulating, drying, total mixing, tabletting, coating, etc. The integrated and intelligent solution can maximize the production efficiency. Tofflon OSD can provide services in four aspects: single-machine equipment supply, system integration, engineering service and process support. It has an OSD experimental center to assist pilot-scale experiments, with a production capacity of 150g-50KG, and build a process connection between laboratory stage and production stage. Provide gravity flow transportation, automatic material transfer, sealing scheme and other materials transfer methods to help build intelligent factories and provide key support from research and development to the implementation of production strategies.
Microsphere solution
The microsphere liquid preparation system is mainly aimed at the preparation of microspheres by single emulsion method, multiple emulsion method, membrane emulsification method and phase separation method. By integrating with screening machine, centrifuge and three-in-one filtering equipment, the filtration and washing functions of microspheres are realized. Micro-filling of microspheres can be realized by freeze-drying, powder sub-packaging or liquid sub-packaging machine. For microsphere liquid preparation equipment, it can be installed in class C environment, and some aseptic transfer or feeding methods can be adopted in C+A environment or RTP barrel transport; For the integration of microsphere preparation with isolator, freeze-dryer, three-in-one and sub-loader, it is necessary to consider the principles of convenient operation for personnel, reducing material loss and facilitating maintenance and repair, and realize the layout of the overall scheme.
Micellar Solution
The equipment of micelle preparation system is mainly applied to the preparation of polymer micelle products, including anti-tumor paclitaxel micelle, polymer micelle of contrast agent and micelle products loaded with biological nucleic acid drugs.
Liposome Solution
The system can be used for the product development and production of drug-loaded liposomes or blank liposomes, and the passive and active drug-loaded methods suitable for liposome preparation can be realized, including membrane hydration method, injection method, gradient method, microfluidic method and other liposome preparation methods.
Emulsion Solution
The system can be used for the development and production of drug-loaded emulsion products or nutritional emulsion products, mainly used for the production of oral milk, injection milk, eye drop milk, external milk and other products; The preparation methods include micro-jet method, high-pressure homogenization method and shear emulsification method.
Suspension Solutions
The suspension preparation system is mainly aimed at the insoluble API, adopting aseptic feeding or in-tank sterilization process, controlling the product particle size through solvent diffusion method, ball milling method and high-pressure homogenization method, and finally preparing a heterogeneous liquid preparation with a certain concentration through the final volume of the finished product tank; The system can realize the functions of filtering and subpackaging the liquid medicine by combining with three-in-one and sub-loader.
Chemical Synthesis Solutions
Chemical synthesis refers to the process of converting simpler compounds into complex organic or inorganic compounds through a series of chemical reactions. The general production process includes: reaction synthesis, separation, purification, drying, crushing, mixing, packaging and so on. It is widely used in the production of peptides, antibiotics, heparin, hormones, and engineering projects. Tofflon API synthesis business mainly covers process design, manufacturing of key process equipment, engineering delivery and validation services for a complete set of solutions for chemical APIs. The business focuses on meeting the production needs of chemical APIs for small molecule drugs, covering the entire process from R&D to production. Tofflon API offers a wide range of advanced API production equipment, including reactors, separation and purification systems, drying equipment, packaging equipment, etc. From process validation, manufacturing control, process performance and quality system, we help you realize product quality transparency and continuously improve product quality.
Biological Fermentation
Tofflon fermentation engineering can meet the fermentation engineering of aerobic, anaerobic or facultative anaerobic bacteria, fungi, algae and other chassis cells. Flexible fermentation system solutions can be built to provide technical services from public system (water, gas, steam, etc.) units, batching units, fermentation units, feeding units to customized post-treatment units, especially in fermentation projects in the fields of probiotics, polypeptide products and synthetic biology. Technical consultation of fermentation system, design of process flow scheme, installation and debugging of fermentation system equipment, transformation and optimization of production process, optimization of clean solutions and cost-effectiveness, to meet the requirements of fermentation system in different scenarios. Advantages: (1) Strict manufacturing and inspection links ensure the sterility of the system and compliance with laws and regulations; (2) Optimized mixing design, air inlet system and heat transfer form ensure the key links of the process, such as mixing, heat transfer and dissolved oxygen. (3) Top-down system engineering design ability, combined with reagent scenarios to do energy optimization and reduce operating costs.
Extraction Class Solutions
Extraction refers to the process of separating the desired components or compounds from a substance or mixture. This process is commonly used in the chemical, pharmaceutical, and food industries, and is often applied to traditional Chinese medicine extraction, health product extraction, and cosmetic extraction. The Chinese medicine extraction solutions are generally targeted at traditional Chinese medicine, Chinese medicine granules, and Chinese medicine injection, and the process is based on the traditional pharmacopoeia formula, and the process is generally as follows: pretreatment, extraction, concentration, water/alcohol precipitation, collection and breeding, drying, or dispensing, etc.; Health care product extraction solutions are generally for plants (tea, single product), animals (fish skin, pig skin, cattle tendon); cosmetic extraction solutions are generally for collection and extraction of essential oils; Tofflon API has the ability to design, produce and integrate; to ensure the uniformity of production management and quality control in all links; to ensure the accurate execution and quick response of equipment commissioning and after-sales. Tofflon API has a very rich industry accumulation in extraction-related fields, has a complete extraction process system and solution, and can provide support in engineering, equipment, consumables and process services to help you from research to commercialization.
Refining, Drying and Packaging Solutions
Tofflon API Refining, drying, packaging solution is divided into solvent crystallization and lyophilization. The production process as follows: liquid dispensing, decarbonization, sterilization filtration, crystallization, filtration/washing/drying (lyophilization), pulverization, vacuum conveying/pulverization/ isolation and sub-packaging, etc. It is mainly applied to sterile drug production, non-sterile API production, etc. Tofflon's solvent crystallization centers on 3-in-1 equipment, integrating dissolution crystallization system, vacuum conveying system, powder processing system, isolation and sub-packaging system, and aluminum barrel transfer equipment, aiming to provide customers with professional and customized solvent crystallization API production workshop solutions. Tofflon's lyophilization centers on the lyophilizer, integrating automatic liquid dispensing system, automatic loading and unloading system, vacuum conveying system, powder processing system, isolation and sub-packaging system, and aluminum barrel transfer equipment, aiming to offer customers customized freeze-drying API production workshop solutions. Tofflon has extensive experience in the field of refining, drying and packaging system solution, possessing complete system solutions, and can provide support in engineering, equipment, consumable, and process service, assisting you in the transition from research to commercialization.
Our Responsibility
Persist in technological innovation
Tofflon brings together global technologies to serve the pharmaceutical industry. We have built advanced experimental platforms for pharmaceutical research, biotechnology, complex preparations and solid preparations, and are committed to building the most advanced pharmaceutical manufacturing platform.
Sustainable Development
We practice the business strategy of sustainable development, use some clean energy instead of traditional energy, and continue to develop green pharmaceutical equipment and facilities with low energy consumption and environmental protection to help the industry achieve the goal of "double carbon"
