Extensive experience

Thorough testing of DS, formulation and primary packaging material

Scientific expertise

Specialized primary packaging is crucial for preserving the stability, sterility, and potency of complex biopharmaceuticals and small molecules, as contamination and product degradation pose significant challenges and risks. The choice of packaging material and type depends on the drug product's form and composition. Pharmaceuticals are vulnerable to external conditions that can cause chemical changes or degradation if not properly protected, especially when exposed to water vapor and oxygen. Whether you are making an initial selection, changing packaging material, e.g. from vials/bags to syringes, or experiencing problems Leukocare supports your drug product development evaluating your drug product (DP) for:

  • Compatibility testing
  • Barrier properties and the permeation rate of factors like moisture, oxygen, and light
  • Container Closure integrity throughout shelf life
  • Extractables and leachables testing
  • Physical and mechanical properties
  • Aging studies via accelerated or real-time stability testing

Primary Packaging Assessment Expertise

Leukocare has many years of scientific experience in identifying the optimal packaging strategy. The compatibility of container closure system, drug substance (DS), and formulation is essential for stability. Our services cover the assessment of available primary packaging materials and container closure system solutions, the ability to test the DS in the formulation and the ability to test the entire drug product for stability. These services reduce the risk of potential problems. We address compatibility of buffers by measuring fragmentation, aggregation, size variants, charged variants, impurities as well as adsorption to surfaces and syringeability, among others. Our formulation expertise is a significant advantage as we can already address potential packaging issues during formulation. Later on in your development process, we can also offer in-use stability studies for example, compatibility with a syringe or infusion set during administration, which could increase the likelihood of clinical and commercial success.

Market research
  • Identify potential container closure systems
  • Container closure risk assessment
  • Product-specific risk assessments
  • Adsorption
  • Break lose / gliding force
  • Spiking studies (e.g, silicon, tungsten)
Pre-formulation studies
  • Feasibility studies for DP stabilization
Stability studies
  • Real-time, intermediate and accelerated stability storage & testing
  • Long-term stability studies (non-GMP)
  • In-use stability studies (non-GMP)
  • Extractables/Leachables