In Use, Compatibility, and Robustness


Process Development

Having an inefficient biologic development process can have significant consequences in later clinical and commercial stages.  Poor product quality and higher than expected costs can create havoc on a drug development program. Recognizing that every biologic drug product is unique, Integrity Bio takes a customized approach when it comes to developing process development. During process development, we identify and optimize process conditions and parameters.

The following are just some of the areas we concentrate on:

  • Sterile filtration
  • Buffer characterization
  • Aseptic fill/finish process development
  • Temperature sensitive formulations
  • Process scale up
  • Engineering runs

Formulation Robustness Study

After a formulation matrix is identified, the stability of the drug product within the specification of each formulation parameter needs to be generated. In addition, the effect of various excursions from controlled stability study conditions on product stability have to be studied.

Examples of robustness studies include:

  • Formulation robustness study
  • Transportation study
  • Process excursion study
  • Temperature excursion study

In Use Stability Studies

The stability of the drug product during intended application processes should be investigated, such as withdrawal from the primary container closure system, expulsion through delivery devices, mixing with diluents, adjuvants, etc.

Examples of In-use Stability Study include:

  • Administration with disposable syringes
  • Administration with IV catheter with or without in-line filter
  • Dilution with IV infusion bag
  • Stability and integrity of multidose formulation over multiple entry

Compatibility Study

Since a drug product comes in contact with other materials, molecules, etc., the drug product’s stability and integrity needs to be demonstrated.

Examples of compatibility studies include:

  • Prefilled syringe compatibility study
  • Extractables and leachables study
  • Secondary container/closure systems
  • Excipient-drug compatibility
  • Drug-drug compatibility study