Esco Aster provides a comprehensive range of analytical testing, quality control, and central laboratory services, either as standalone offerings or as part of our integrated end-to-end development and manufacturing platform.
Our testing capabilities span the entire product lifecycle, from process development and clinical manufacturing through product release and clinical administration. Services include contract quality control testing, stability studies, container-closure integrity testing (CCIT), transport validation in collaboration with third-party logistics providers, and final product preparation studies such as controlled-rate thawing, cryoprotectant removal, formulation optimization including culture rescue, drug administration compatibility with potency testing, and infusion set stability assessments.
In addition to product contract testing, Esco Aster offers specialized central laboratory services supporting clinical trials, translational medicine, biomarker discovery, and diagnostic development. These services encompass patient screening, companion diagnostics (CDx), complementary diagnostics (CoDx), biomarker development, and longitudinal monitoring throughout clinical studies.
Complementary diagnostics provide additional information about the use of the therapeutic product, medicine, theranostic and are often developed as a standalone. An example will be for instance PCR test to perform nodule risk stratification post Low Dose Computer Tomography (LDCT) scan.
Companion diagnostics are developed and filed together with the therapeutic product; cell- gene therapy, and tests must be taken in order to determine if the medical intervention is administered.
Our central laboratory capabilities support the assessment of treatment response through screening of medical conditions especially for oncology (e.g. Multi Cancer Early Detection MCED) and fertility, biomarker development and analysis, minimal residual disease (MRD) monitoring, and identification of responder and non-responder patient populations, enabling improved patient stratification and precision medicine approaches.
Services can be delivered across multiple regulatory pathways, ranging from Research Use Only (RUO) common for phase I and II clinical trial material, Laboratory Developed Tests (LDTs) to fully regulated diagnostic products developed in compliance with CE marking, ISO 13485 or ISO 15189.
Esco Aster supports the development and manufacturing of companion and complementary diagnostic solutions across a range of advanced biological modalities, healthcare speciality areas including integration with our exosome and extracellular vesicle biomarker discovery platforms.
Our capabilities include:
Research-use-only (RUO) diagnostic kits can be developed and manufactured by Esco Aster within our GLP laboratories. For GMP-grade products, Esco Aster may manufacture products in-house or collaborate with qualified manufacturing partners, depending on the product requirements, while supplying critical GMP-grade biological components, including antibodies and recombinant proteins.
Antibodies and recombinant proteins are typically produced using adherent mammalian expression systems, including CHO, HEK293t, and hybridoma cell lines, leveraging Esco Aster's proprietary Tide Motion™ adherent bioreactor platform to support scalable and cost-effective production.
Esco Aster provides biospecimen collection and kitting services in Singapore, either directly or through qualified partners, serving as a single point of project management for sponsors conducting clinical studies.
These services can be integrated with our broader clinical development, manufacturing, and logistics offerings, particularly for early-stage Phase I and Phase II clinical programs. Our focus is on supporting emerging biotechnology companies and academic investigators conducting studies across Southeast Asia, South Asia, and Australia/New Zealand (ANZ) markets.
Our capabilities include:
In addition to human therapeutic and diagnostic applications, Esco Aster's testing and diagnostic development capabilities extend to:
For custom analytical testing, diagnostic development, central laboratory services, or specialized project requirements within Singapore, Asean, South Asia and Oceania region, please contact Esco Aster to discuss your specific technical and regulatory needs.
Email: [email protected]