More than 20 years of 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, as contamination and product degradation pose significant challenges and risks. The choice of packaging material and type depends on the drug'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 challenges with your container, Leukocare supports your drug product development evaluating your primary packaging for:
Compatibility with the drug product
Barrier properties and the permeation rate of factors like moisture, oxygen, and light
Container Closure integrity throughout shelf life
Sterility Assurance
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, DS, and formulation is essential for stability. Our services cover the assessment of available primary packaging and container closure system solutions, the ability to test the drug substance in the formulation buffer and the entire drug product for stability reduce the risk of potential problems. We address suitability 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
Compatibility/Functionality
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
