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The need for advanced containment solutions, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.

Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. Absent water, degradation processes are greatly reduced. In any primary package system (i.e., vial, elastomer stopper, seal) for a lyophilized drug product, of utmost concern are leachables and volatile organic compounds that may migrate from the elastomer stopper into the lyophilized drug product, creating a risk to patient safety.

On July 3, 2013, Novartis issued a voluntary recall of its Menveo^® vaccine. Menveo is a lyophilized meningococcal vaccine used against Neisseria meningitidis, a bacterium that causes meningitis, meningococcemia and septicemia, and rarely, carditis, septic arthritis or pneumonia.

When choosing an elastomeric formulation for a stopper or plunger used to package parenteral drug products, there are several misconceptions related to the importance the elastomer class plays on the chemical and physical properties of the elastomer. Often we hear customers make general statements such as “chlorobutyl elastomers are better” or “bromobutyls have an advantage in property X.” In actuality, each elastomeric formulation is unique and has different properties that are independent of the class of elastomer.

Subvisible particulates (defined as those in the 0.1-10 micron range) are a growing concern for injectable drug manufacturers. The particles may cause aggregation, which can impact the drug product and create a potential safety risk for the patient. To help ensure product quality, the U.S. Food and Drug Administration recommends that manufacturers gain a better understanding of how subvisible particles impact the drug.

When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers.