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Assay Development & Testing

Vibalogics develops, establishes, qualifies and validates product specific, EP and USP analytical methods for use as in-process controls or product release assays using an array of state of the art analytical tools both as part of a manufacturing project, or as a stand-alone service.

Vibalogics offers a full analytical method development and analysis service to complement its manufacturing services. We provide a comprehensive service, which not only covers product development and manufacturing, but also in-process, bulk intermediate and final product release analysis.

Vibalogics holds a “handling permission” from the local authority for many pathogenic bacteria used as reference material for biological assays. This allows us to work with some organisms that other companies cannot handle in their facility. We also recognize the importance of developing biological assays that exhibit low variance and ensure that the assays we develop keep biological assay variance under control as far as possible.

We believe that a full tool kit of assays should be available for our customers to choose from, which is why we have selected and audited a number of third party testing facilities to provide specific services that would not be cost effective for you if we performed them. However, all interactions with these facilities are managed by Vibalogics to keep the communication network simple and effective.

Vibalogics offers:

  • Comprehensive list of assays for identity, potency, purity and safety
  • Assay development or transfer of existing assays to our facility for use as in-process or release testing
  • Selected third party testing facilities audited and approved by Vibalogics to benefit our customers
  • Qualification or validation based on EP or USP or ICH Q2(R1) guidelines

All GMP assays at Vibalogics are performed to SOPs to ensure the highest level of reproducibility and confidence in the results obtained.

Our Assay development and testing service is available as a stand-alone service as well as in conjunction with our manufacturing service, so why not speak to us today to find out how we can help you with your analytical testing requirements.

For more information regarding Lyophilization Assay Development & Testing, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Lypho

A comprehensive service to companies requiring…

…virus and live bacterial products filled for clinical trials