Injection Research & Development and production services from preclinical to commercial
● Experienced R & D team, complete production equipment and advanced production facilities.
● Complete the process development optimization and scale-up production of dosage forms such as sterile injection solutions and sterile lyophilized powders.
● One-stop services such as pre-formulation, formulation design, process development optimization and scale-up, and clinical / commercial cGMP production.
Impressive injectable Research & Development capabilities
The Injectable Formulation R&D Laboratory has advanced equipment and can complete a series of operations such as weighing, compounding, filtering, filling, ampoule closing by hydrogen-oxygen flame, autoclave sterilization, freeze-drying, capping, and more to simulate the GMP production.
60% of R&D team members have master‘s degree and 20% have Ph.D. degree. All are experienced in the research of injectable technology, ensuring that standard, high-quality and efficient completion of formulation and process development. They all have rich experiences in development and regulatory application of innovative and generic drug products, and can provide one-stop, systematic injectable formulation R&D services covering innovative and generic drug products to meet the needs of customers at different research and development stages.
● Dosage forms
Sterile injections (ampoules / vials), sterile lyophilized powders (vials)
● Technology platform
Solubilization of poorly soluble drugs, development and optimization of lyophilization process cycles, development and evaluation of sterilization method, residual oxygen control in headspace of container, Injectable formulation development for high potent APIs
● Technical advantages
We can customize development plan, optimize formulation design, reduce consumption of raw materials required for formulation and process development, reduce research and development costs and save resources and time.
Manufacturing of Injectable drug products
There are three injectable production lines in Asymchem. Different injectable dosage forms from pre-IND, phase 1/2 and even commercial stages can be manufactured by modern facility and equipment.
● Automatic compounding systems with on-line CIP/SIP.
● Filling and sealing machine with online automatic sampling, pre- and post- nitrogen filing
● Mini KuFill sterile isolator with filling, freeze drying and capping
● Pharmaceutical water preparing system with automatic program controlled operation
● HVAC systems with automatic temperature / relative humidity condition
IND submission batches, CTM production, process validation, commercial batches
With advanced production equipment, reasonable production process, good quality management system, strict QC and good sterility assurance system, strict implementation of cGMP requirements is ensured. According to different stages of customer projects, experienced teams will customize appropriate process scale-up strategy and compact and reasonable production cycle for customers.