One-stop formulation development and manufacturing services from pre-IND to commercialization
Asymchem aims at providing an one-stop service from pre-clinical to commercial formulation development by our research team, professional technical platforms, advanced manufacturing equipments, and complete quality systems. We will tailor an exclusive R&D strategy for you in any stage of the formulation development and manufacturing, and bring the formulations to clinical trials and markets rapidly.
Our platform includes:
● solid state science and pre-formulation research
● formulation and process development
● analytical method development and verification
● clinical product manufacturing
● registration declaration and commercial production
New drug R & D platform in Asymchem
The new drug deliver research center is primarily engaged in the development and evaluation of innovative formulations and 505(b)(2) NDAs , with the exclusive platform including solubilization and nano-based technology.
The research of the R & D center for innovative formulations covers pre-formulation research, formulation and process development, analytical methods development and verification, and in vitro and in vivo evaluation . New drug delivery research center aims at accelerating the industrialization of new drugs and the developing of new models of precision medicine.
Formulation Research & Development
The Asymchem new drug delivery research center is experienced in formulation and process development, focusing on developing solubilization technology and complex formulations for oral and parenteral administration on small molecules and macromolecules.
● Small molecules: active drugs with low solubility or low permeability , mainly BCS II, III and IV
● Macromolecules: peptides, proteins and nucleic acids
● Oral formulations: tablets and capsules based on solid dispersions, nanocrystals, inclusion complex and etc.
●Parenteral preparations: injections, transdermal formulations and inhalants based on liposomes, nanoemulsions, microspheres and etc.
● Development of innovative formulations; Evaluation and prediction of stability data; Process design, optimization and verification; Process risk assessment and establishment of quality control measures.
Solubilization technology and nano-based platform
The new drug deliver research center has exclusive platform based on solubilization technology and innovative formulation development. The design of complex formulations with specific in vivo delivery requirements is based on the properties of drugs,. The research and development content includes but is not limited to the following aspects:
● Pre-formulation research: solid form screening and selection, formulation development strategies
● Development and assessment of solubilization technology including solid dispersion, Nano crystal, inclusion, emulsion and etc.
● Development and assessment of formulation including liposomes, microspheres, nano-emulsions and etc.
● Analytical method development and verification for solubilization technology and complex formulations
● Evaluation in vivo and in vitro, including characterization of formulation properties and cytology evaluation in vitro, pharmacodynamics evaluation in vivo
Research & Development foundation
The new drug deliver research center has a construction area of 2,000 square meters. The research building has pre-formulation, formulation research and development, formulation analysis, and IP departments. The new drug deliver research center is equipped with international advanced formulations and analytical experimental equipments, which can meet the development of various types of formulations.
The new drug deliver research center has established strategic cooperation with renowned research institutions, universities and pharmaceutical companies throughout the world, to provide an optimized platform for the formulation development and the technology transfer. The R & D center has established long-term cooperation with China Pharmaceutical University, Shanghai Fudan University and other well-known universities in the area of nano-based formulation development and solubilization technology, which aims at industrial transformation of advanced research and technology in Asymchem new drug deliver research center .