GMP-Creative Biolabs provides one-stop customer-oriented services including biopharmaceutical contract R&D, process development, cGMP manufacturing, QA & QC solutions for scientific research, preclinical, clinical and commercial supply. We proceed your projects according to your specific demands in quality, timeline and budget, supporting researchers across different therapeutic areas. Clear, open and regular communication with customers is as important to our success as our in-depth scientific knowledge. more
With abundant experience of GMP research and development, Creative Biolabs now provides a custom comprehensive package of analytical methods development and validation services to our customers. Numerous types of methods are available for a wide range of solid-state analytical approaches in the application for progress development, GMP manufacturing and quality control solutions.
Developing a validated qualitative and quantitative method for progress development can be a considerable challenge with a number of significant pitfalls if the method development is not scientifically sound. In addition to the scientific challenges are the challenges imposed by GMP and the requirements imposed by following the recommended ICH guidelines for qualitative and quantitative method development. Analytical biologists and chemists continuously search for increased sensitivity, greater accuracy, and improved precision in the qualitative and quantitative methods they develop. Traditionally, equipment improvements have lead to better method performance. More recently, multivariate/chemometric data processing approaches have shown tremendous enhancements in method performance.
Creative Biolabs will present and deliver a comprehensive report including detailed procedures and results for all method development and validation for your project, such as analytical methods, protocols when applicable, all test results, appropriate graphs and calculations, and sample raw data.
Our characteristics and analytical platforms include:
|Shape/Higher Order Structure||CD, X-Ray, NMR, Epitope Detection, Specific Binding|
|Assay/Activity||CD, HPLC, AAA, ELISA, Octet, Bioassay|
|Size/Aggregation||SEC, CE-SDS, AUC, AFA, LLS|
|Purity||RP-HPLC, SEC, Peptide Mapping, CE-SCS, FFF, ELISA, Immunoblot, DNA, LAL, Virus|
|Surface Charge||cIEF, CZE, IEX|
|Carbohydrate Analysis||ESI-MS, TOF, Separation of Labeled Released Carbohydrate|
|Identity||N- terminal Sequencing, Peptide Mapping, Bioassay, cIEF, ESI-MS|
|Structure/Sequence||N- and C- terminal, Amino Acid Analysis, Peptide Map/Sequence, Monosaccharide Analysis, Oligosaccharide Mapping, Sialic Acid, MD, Disulphide Linkage|
Based on our combinatory and comprehensive package of analytical methods, Creative Biolabs has come to the unique position to not only have the technology and experience necessary for methods development and support, but also the capability to provide these analytical services in the most cost and time efficient manner.
To discuss your Analytical (Method Development) demands or to request a proposal, please contact us by
For R&D use only, not directly for clinical use.