- 13Jan2018
-
[Whitepaper by Mithra]
[Whitepaper by Mithra]: Mithra expands pre-clinical facility and strengthens GMP expertise providing global support for pharmaceutical development
Mithra Biotechnology Inc., the first Contract Research Organization (CRO) in Taiwan offers integrated and multi-dimensional CRO services, including full characterization panels for biologics in accordance with ICH Q6B and bioanalytical services for chemical drugs and biologics, to assist pharmaceutical development during discovery, CMC preparation, registrations, manufacturing and clinical trials.
Can you share the history of Mithra Biotechnology?
We were established in 1988 as the first CRO in Taiwan specializing in Bioavailability/Bioequivalence(BA/BE) studies for generic drugs. In 2011, Mithra merged with Mass Solutions Technology who offers characterization services for biopharmaceutical development. Since then Mithra has grown rapidly and added additional service lines to meet market demand. We are the only CRO in Taiwan that offers analytical and bioanalytical services for both small and large molecules to assist in pharmaceutical development. Throughout our growth, Mithra has consistently maintained the highest service quality and accreditations.
What specific expertise does Mithra provide and how is that different from competition?
We have core expertise in analytical method development for small molecules and biologics. This makes Mithra one of the few leading players in Taiwan and Asia, with significant experience in biological products. We have diversified services for monoclonal antibodies, growth factors, antibody drug conjugates (ADC) and various other proteins. This includes pharmacokinetic studies of biologics and structural characterizations such as primary structure analysis, terminal sequencing, PTMs identification, disulfide bond assignment, carbohydrate structure analysis and peptide mapping targeted to biosimilar comparison or lot-to-lot QC, and degradation/impurities profiling. Additional CMC laboratory services for API and drug products are available in our GMP compliant laboratory.
Our clinical research team is well versed in the support and management of early to late clinical trials. We have extensive experience in BA/BE trials for generic drug testing. Our labs and clinical facility are fully accredited with robust quality systems. We have been successfully inspected by the USFDA in 2017 and have GLP certification accredited by the Taiwan FDA and OECD. We are an NPRA (Malaysia) certified BE center. This facilitates the acceptance and recognition of data from our BE studies by all ASEAN countries.
What will drive Mithra’s growth over the next 5 years?
Mithra is aggressively evolving into an international brand with clients ranging from the USA, Russia, China and Japan. Further expansion throughout Asia is the goal for 2018. To facilitate that growth Mithra will be opening an analytical laboratory and preclinical facility in Shanghai, China this year. According to Stone Shi, CEO of Mithra, “the capability within this 2500-square meters facility includes comprehensive pharmacology evaluation on various disease/animal models such as nonhuman primates and bioanalysis for both small molecule and protein drugs. The whole operation will be based on international GLP standard to fulfill the regulatory requirement.”
What alliance and partnerships does Mithra have?
Jigsaw, based out of Kuala Lumpur Malaysia, is a full service CRO with clinical monitoring, data management, biostatistics, and medical writing services, has become our strategic partner for Southeast Asia market in 2017. Jigsaw is an integrator and driver of the clinical development process, managing multiple complexities on behalf of its clients. In this capacity, Jigsaw is able to partner with best in class organizations to provide cutting edge analytical and clinical services. Jigsaw, as the name implies, puts the pieces together.
