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OptiGel® Bio Technology

ENABLING IV TO ORAL CONVERSION OF MACROMOLECULES

Currently, due to permeability, stability, and delivery challenges, the dosing of macromolecules has been traditionally delivered in an intravenous form. Intravenous drug delivery, while able to provide an optimal pharmacokinetic therapeutic profile, presents challenges such as ease of use, dosing frequency, regulatory challenges, costs, and compliance.

Catalent OptiGel® Bio technology incorporates a proprietary technology that may overcome the traditional hurdles by enhancing permeability and enabling a targeted delivery through enteric coating. Catalent’s development expertise can rapidly identify an optimal Oral formulation enabling the traditional benefits of an oral softgel formulation and subsequent commercialization.

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OPTIGEL® BIO BENEFITS

GPEx® technology uses a retrovector technology that ensures the stable transduction of targeted cells, approaching 100% efficiency. This level of efficiency eliminates the requirement for selectable markers and stable clonal cell lines are produced rapidly.  GPEx® technology utilizes additional transductions to increase copy number or to add other complementary genes.

Single and Multigenic Applications

  • Monoclonal antibody (mAb) heavy- and light-chain co-expression
  • Receptors, co-expressed with a secreted surrogate
  • Inactive proteins, co-expressed with associated processing enzymes
  • Sequential transduction can be used to introduce required genes without antibiotic selection
  • Expression can be enhanced by clonal selection or additional rounds of transduction without antibiotic selection

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VALUABLE PRODUCT DIFFERENTIATION

  • Proprietary technology and process.
  • Improved patient adherence – fewer physician visits, less painful administration.
  • Customization of therapeutic profiles.

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CATALENT CAPABILITIES

We have a long track record of customizing successful programs involving our proprietary advanced technologies:

  • Pre-formulation and feasibility studies.
  • Permeability screening of macromolecules.
  • Softgel capsule fill formulation development.
  • Small-scale lab encapsulation for early stability data and final formulation selection.
  • Capsule shell development.
  • Strong IP (intellectual property) positions including fill formulations for improved bioavailability.
  • Extensive technical support in softgel capsule product development.
  • Reliable supply from clinical phases to commercial manufacturing.
  • Contingency planning and quality assurance via our large global network.

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FACILITIES

Our deep formulation expertise supported by a global infrastructure of FDA, EMA and locally accredited cGMP softgel facilities will provide a catalyst to your success by tailoring a unique drug delivery solution to bring your product faster to market.