Analytical Testing and Release

Analytical Testing and Release

The drug development is always challenged by issues like quality, safety, complex procedure of manufacturing, and increased strict regulatory requirements. Given these concerns, BOC Sciences provides contract pharmaceutical analysis and release services to support your project program from the early phase of study to late stage formulation development and to post-marketing analytical support. Knowing the great importance of physicochemical properties of drug compounds and products to your successful submission, our scientists will offer a comprehensive analytical study for all aspects and finally provide you with the robust analytical data.

Below is a list of our analytical testing and release services (include but not limited to the following):

  • Potent Cytotoxicity Test and its Progress
  • Packaging, labelling and storage of products.
  • Data management and statistical analysis of data.
  • Full report-you will receive a complete, fully recorded packet ready to be submitted to FDA.
  • Equipped with a suit of top-notch analytical techniques such as UPLC, LC/MS/MS, GC, NGI, ACI, ELISA, SDS-PAGE, HPLC combined with UV, PDA, FLU, ELSD, RI, and CAD, etc.
  • A range of products including pharmaceutical products (tablets & capsules, liquid formulations, semi-solid products, injectable, creams, aerosol, transdermal, etc.), biopharmaceutical products (biosimilar, protein therapeutics, monoclonal antibodies, oligonucleotides, etc.), excipients, APIs, medical devices.
  • Physicochemical properties testing including appearance, degree of coloration, loss on drying, sterility, turbidity, density, bacterial endotoxins, and other compendia testing.
  • Full range of microbiological analysis including sterility testing, bacterial endotoxin testing, bioburden analysis, microbial identification, preservative efficacy testing and microbiological antibiotic assay.

Why choose BOC Sciences?

BOC Sciences offers a complete stability program with ICH, cGMP and global storage conditions. We have a specialist analysis capabilities for a variety of complex products including drug compounds, excipients, bio/pharmaceutical products and others. We bring quality and safety to life by accelerating the process of drug development, providing the most valuable data that facilitate marketing authorization submissions.

References

  1. Wang, Q., Ma, D., & Higgins, J. P. (2006). Analytical method selection for drug product dissolution testing. Dissolution Technologies13(3), 6.
  2. Ritter, N., Russell, R., Schofield, T., Graham, L., Dillon, P., Maggio, F., ... & Yang, H. (2016). Bridging Analytical Methods for Release and Stability Testing. BioProcess International14, 2.
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