By Justin J. Kim and Kenneth McMahon, Samsung Biologics
Through the integration of CDMO services with CRO analytical testing services, biologics makers will be able to deliver high-quality products faster than ever before, with greater flexibility and no dependence on external service providers.
With thousands of methods developed, validated, and/or transferred in support of IND/ANDA/NDA/BLA applications, the scientific team at Nitto Avecia Pharma Services’ has a proven track record with nearly all drug forms, substances, and products.
GVK BIO offers a range of formulation R&D solutions that includes preformulation studies, formulation development, analytical R&D, reformulation, and stability studies. GVK BIO can also support clinical supplies and manufacturing of exhibit batches in collaboration with partners and offers standalone analytical solutions for third-party formulation products.
Biomarkers and deep insights into drug candidate response in both preclinical models and clinical trial subjects are a cornerstone for illuminating decisions across the drug development process. Learn how metabolomics — by producing a comprehensive and meaningful assessment of the molecular phenotype — can enrich the biomarker and information armament to inform decisions across this continuum.