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Formulation Evaluation and Lyophilization Cycle Development

A stable formulation and optimum lyophilization cycle are critical to product success and cost-effective production.  Establishing these parameters early on is essential and Vibalogics helps its customers to do this effectively.

Vibalogics specializes in aseptic drug product manufacturing and has a spaciously designed fill and finish suite with Grade A/B classification. Prior to manufacturing the Drug Product, establishing a suitable formulation and optimum cycle for the lyophilization process is crucial.

Vibalogics’ formulation evaluation services include:

  • Systematic screening of potential formulations based on industry standard recipes that are accepted by the regulators
  • Comprehensive analytical package to support formulation screening (e.g. live titre analysis, residual moisture, lyo-cake appearance, other product-specific potency assays as required)
  • Real time and accelerated stability packages to confirm stability in line with ICH guidelines

Vibalogics’ Lyo-cycle development services include:

  • Development activities transferable to GMP equipment
  • Comparative pressure analysis (MKS and Pirani) in PD for end-point analysis
  • Wireless temperature probes in PD lyophilizer
  • Detailed software for analysis and optimization of the lyo-cycle
  • Evaluation of design space comprising e.g. shelf temperature for 1° and 2° drying phases, chamber pressure, ramp rates, residual moisture in product

In addition to the services we have in-house, we use a network of partners to perform more complex methods (for example, Tg’, Tc and Tg by mDSC, FDM, DTA, Impedance) for critical formulation characterization on our behalf and, therefore, offering a truly holistic approach to the development of your product.

Call us today to discuss your Formulation and Lyophilization Development requirements either as an independent service, or as part of a full manufacturing project. +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