Pharmaron is a premier R&D service provider for the life science industry. Founded in 2003, Pharmaron has invested in its people and facilities, and established a broad spectrum of drug R&D service capabilities, ranging from synthetic and medicinal chemistry, biology, DMPK, pharmacology, safety assessment, bioanalysis, radiochemistry and radiolabelled metabolism to chemical & pharmaceutical development. With over 4, 000 employees and operations in China, the U.S. and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron’s mission is to provide the highest quality of R&D services while helping our customers advance their projects in a timely and cost effective manner.
- Chemistry: Pharmaron’s chemistry service unit is one of the largest chemistry research organizations in the world. Productivity, efficiency/speed, and innovation/problem solving skills have driven rapid expansion of our chemistry services. We have extensive experience and expertise in the following major chemistries: general organic synthesis (heterocyclic, organometallic, organofluorine, etc.), library synthesis, chiral chemistry (asymmetric synthesis, chiral separation and resolution), medicinal chemistry, computer-assisted-drug design and cheminformatics, bioorganic synthesis (nucleosides, nucleotides, lipids, peptides and bioconjugates), process chemistry and scale-up, and analytical chemistry and purification.
- Biology: Pharmaron provides a broad spectrum of high quality of biology services to support various types of drug discovery and development programs. Our biology team is experienced in biochemistry, molecular and cellular biology, and structural biology. The team has established a proven track record in customer assay development, compound evaluation using platforms including cell-free biochemical assays, cell culture models, biomarker analysis and crystal structure determination for proteins complexed with small molecules.
- in vitro ADME : Pharmaron offers a comprehensive panel of in vitro ADME assays including solubility, metabolic stability (microsomes, liver S9 fraction, hepatocytes), permeability, plasma protein binding, CYP inhibition/induction and phenotyping, transporter inhibition, metabolite identification and in vitro toxicology.
- in vivo PK: Pharmaron offers comprehensive in vivo pharmacokinetic (PK), toxicokinetics, tissue distribution, PK/PD correlation by working together with in vivo pharmacology team, and discovery bioanalytical services to our partners.
- in vivo Pharmacology: Pharmaron’s in vivo pharmacology services include oncology, cardiovascular and metabolic diseases, CNS, pain, inflammation and other established animal models and procedures. The oncology platform includes human cancer cell xenograft models, PDX models, drug resistant models, imaging based models, and models suitable for immuno-oncology approaches, to mention a few..
- Safety Assessment: Pharmaron’s safety assessment facility is a GLP compliant preclinical center providing services to evaluate potential drugs’ safety liabilities. The facility follows the GLP requirements by FDA, CFDA and OECD to conduct studies for IND and NDA filings with FDA, CFDA and EMA and other regulatory authorities. Equipped with state-of-the-art instruments, labs and animal facilities, our safety assessment team, which is technique-wise highly experienced with rich experience in working with regulatory authorities, has delivered high quality of data and reports to our sponsors to facilitate the preclinical development of drug candidates. Working together with DMPK, in vivo pharmacology and CMC teams in Pharmaron, the Safety Assessment team has been able to contribute to the delivery of the entire IND packages in Pharmaron for regulatory filing in a highly efficient manner.
- Chemistry, Manufacturing and Control (CMC): Pharmaron CMC provides fully integrated drug development and manufacturing services, including design and discovery of new scalable routes, optimization of existing routes for quick scale up and development of robust manufacturing processes, manufacturing of intermediates to hundreds of kilograms scale, and GMP API up to 20-kilogram scale. Our CMC services also cover analytical development, stability evaluation, pre-formulation, formulation development and CMC regulatory filing document for both China and Global submission.
- Clinical Support: Pharmaron can conduct clinical analytical testing, in a GCP compliant manner, to support needs from clinical development of small-molecule-based and biologics-based therapeutics, at various clinical stages. The GCP compliant analytical platform equipped with state-of-the-art analytical instruments led by experienced industry leaders, can perform bioanalytical method development and validation, and the subsequent clinical sample analysis, not only for test articles and also for biomarkers. Immunogenicity and immunotoxicity studies can also be carried out for biologics.
- Radiolabelled Sciences: Early stage and specialist drug development services, including radiochemistry, drug metabolism and e-fate solutions tailored and integrated to sponsors, using state-of-the-art technologies underpinned by unparalleled scientific, chemical and biological expertise, including QWBA and MARG. The clinical metabolism platform at Pharmaron evaluates the metabolic profiles of the therapeutics in clinical trials, including the identification, structure characterization and quantification of major metabolites, using radiolabelled therapeutics administrated to human. The in-house radiochemistry platform and proprietary Radiotag technique that can radiolabel biologics allow easy access to radiolabeled small molecules and biologics based therapeutics. The evaluation is performed following regulatory requirements, in a GCP compliant manner.
- Integrated Services: Pharmaron offers integrated drug R&D services by integrating various technology platforms together, including synthetic chemistry, medicinal chemistry, CADD, DMPK, in vitro biology, in vivo pharmacology, safety assessment and CMC, to allow us to provide high quality of integrated services and speed up the drug discovery and development process. Our integrated services include 1) integrated discovery services to support PCC selection, 2) integrated preclinical service to support IND enabling and regulatory needs, and 3) integrated clinical service to support NDA filing.