Novotech laboratories

Our bioanalytical services assist our customers in every stage of their molecule development. We established our first bioanalytical laboratory in Taiwan in 1997, and we have subsequently established or acquired three additional bioanalytical laboratories in Xuzhou, Jiangsu Province and Shanghai in China and Seoul, South Korea. We also operate our central laboratory, which was established in Taiwan in 2002 and which is accredited by The College of American Pathologists. Our bioanalytical laboratories are among the earliest in Asia that use liquid chromatography with tandem mass spectrometry (LC-MS/MS) assays, which is a powerful analytical chemistry technique that combines the physical separation capabilities of liquid chromatography with the mass analysis capabilities of mass spectrometry. 

We have about 100 employees at our five laboratories and 34 LC-MS/MS machines. We completed over 600 laboratory projects since 2018 and have completed over 510 validated assays. We have capacity to process approximately 34,000 samples per month (representing 1,000 samples per LC-MS/MS machine per month). 

Central Laboratory Services

Our central laboratory services include:

  • Clinical core laboratory testing. We provide high-quality control programs to ensure every step of testing, from specimen requisition to laboratory report, is seamlessly managed through the implementation of globally-recognized quality standards and laboratory automation systems. These services include hematology and coagulation, chemistry and immunoassays, genomics and molecular assays, urinalysis and protein analysis. To meet the niche needs for immunotherapy, cell therapy, and prophylactic and therapeutic vaccines development, we have established a number of methods for cell surface marker analysis using the flow cytometry assay.
  • Immunochemistry for biologics. We have strong capabilities in bioanalytical method development and validation for large molecular therapeutic drugs on PK, anti-drug antibody and neutralizing antibody assays with more than 100 analytes. 
  • Biomarkers. Our experts work closely with our customers, assisting them in identifying appropriate biomarkers, analyzing regulatory approaches from fit-for-purpose to full compliance, selecting the suitable analytical technology or method, and developing and validating specific assays.
  • PBMC processing. We process PBMC (peripheral blood mononuclear cells) in applying our robust proprietary methods and can create customized SOPs upon our customers’ request. Our extensive logistics network enables us to transport specimens from clinical trial sites from a majority of the sites across Greater China to our facilities within the expected timeframe based on stability requirements. We can process PBMCs according to our standard SOPs on the day of receipt, if required. We provide long-term storage in gasphase liquid nitrogen tanks.
  • Alliance source for testing. We have created a strong network across the Asia-Pacific region with alliance laboratories that have specific expertise in different fields. Additional services that we can provide through this alliance include anatomical pathology; molecular pathology; cell-based assays and flow cytometry; single nucleotide polymorphism (“SNP”) genotyping; next-generation sequencing; heavy metals assays; drugs and narcotics testing; newborn screening; and mass spectrometry.
  • Laboratory data management. Our laboratory information management system is access-controlled with high-security systems and a complete audit trail to ensure the competence of all data. Our services include project-specific database construction; daily and monthly third-place backup; demographic verification; panic alert; exclusive alert and customized data alert services; and electronic data generation and transfer. We also have the ability to access and monitor nearly real-time data of clinical trials.
  • Bio-storage. We provide 24-hour security and 24-hour monitoring systems for bio-sample storage, including gas-phase liquid nitrogen tanks, deep freezers, freezers, refrigerators, controlled room temperature environments, and special storage services for PBMCs.
  • Kit supply. We provide protocol-specific laboratory kits and other supplements, such as instruction manuals, project-specific kits, import/export permit applications, and expiry date tracking and reminders, to ensure the quality and accuracy of our customers’ studies.
  • Bio-sample logistics. We provide a variety of solutions for bio-sample transportation to meet our customers’ requirements. These services encompass specimen shipment coordination services; in-bound and out-bound bio-sample shipments with SOP controls; ambient, refrigerated and frozen shipping conditions with temperature controls; domestic shipments within 6-, 24- and 48-hour requirements; and import/export permit applications including those for infectious bio-samples.
  • Project management. Our project management team members have extensive experience in managing different types of clinical trials. Every project is assigned its own project manager. From the initial protocol review to project closure, we assist our customers at every stage in on-site training, laboratory instruction manual implementation, project monitoring and control, risk management, budget management, timely communication and resolution of issues, administrative support and coordination among sites, clinical monitoring teams, other laboratories involved in the studies and customers.