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GMP-Creative Biolabs, One-stop, Full cGMP Service, Fasten Your Process to Cinical and Market

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USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-871-5806
Fax: 1-631-207-8356
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Analytical (Method Development)


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:

CHARACTERISTIC ANALYTICAL PLATFORM
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