Kindos leverages global expertise in the pharmaceutical industry to achieve high efficiency and high value-adding in drug R&D. Kindos is dedicated to facilitating cross-team coordination, accelerating time-to-market, enhancing quality, consistency and reliability, ensuring seamless technology transfer, maintaining robust project control and enhancing regulatory compliance. By developing and manufacturing high-quality injectable drugs, we deliver excellent and efficient professional services to fulfill the professional mission of our team.
Kindos professional development team with international experts, is capable of development of high-valuable generics, 505(b)(2) applications and innovative drugs. Our services cover all aspects of the R&D stage, including but not limited to pre-formulation research, QbD-based formulation study, process development, analytical method development and validation, E&L study, stability study, process scale-up, pre-clinical and clinical batches manufacturing, and regulatory submissions. Kindos R&D center can develop challenging drug products, including those that are photosensitive, oxygen-sensitive, moisture-sensitive, temperature-sensitive, highly potent, organic-solvent lyophilization, poorly soluble, or prone to hydrolysis. Through dedicated, customized and highly efficient project management, we significantly enhance the efficiency of technology transfer from R&D to production.
Kindos maintains a leading position in the development and industrialization of complex formulations, including emulsions, micelles, liposomes, encapsulations, nanoparticles and suspensions, several of which have been approved and commercially launched.
Relying on the "US-China-EU" innovative biomolecule expert team, the company has robust capabilities in cell line development, production process development and quality study. With more than ten years of experiences in process development and process characterization of antibody products, our team provides professional technical support to enable clients to achieve low-cost, readily convertible easily transferable and stable production within a short timeframe. We can provide expertise-derived, thorough solutions based on identified DNA or protein sequences, resulting in high-yielding cell lines capable of stable expression within 3 to 5 months.
Leveraging Kindos global R&D platform resources and integrating US, China, EU and ICH requirements, we have developed technical capabilities in nucleic acid design, process development and quality research of mRNA drug development. Our platform is designed to support advanced mRNA commercialization and manufacturing, encompassing the entire mRNA industry chain from design to production.