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Join West’s Diane Paskiet at the 2013 PDA/FDA Container Closure Components and Systems Workshop:Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems, on May 14-15, 2013, at the Hyatt Regency Bethesda in Bethesda, Maryland.
This 1 1/2 day workshop will tie together a broad scope of attributes for container closure systems and the potential impact to the quality of therapies from the point of component selection, to the manufacture of the medicine and delivery to the patient. The discussion will touch upon packaging materials, components, delivery systems, human factors, supply chain and Quality by Design.
Quality attributes for container closure systems span a wide spectrum of considerations and should be predetermined for intended use, designed with ‘end in mind,’ established based on proven chemical, physical and functional characteristics and well integrated across product life cycle. This program will address current requirements, technology trends and applied principles for establishing container closure systems that fit patients, products, manufacturing platforms and market demand.
For more information or to register to attend, visit www.pda.org/containerclosure2013
Competition is increasing in the biopharmaceutical pipeline due to a growing number of new entrants, more players are bringing their drug all the way to market and many companies are utilizing accelerated development pathways, making it an even faster race to market. If you are like many other newly formed biotech companies, you’re doing your best to manage many activities critical to your success with limited resources, all while trying to accelerate your path to market.
The current global market of prefilled syringes is comprised of over two billion units per year and growing. Many chronic diseases, such as multiple sclerosis and rheumatoid arthritis, require home-based administration of injectable therapies.
Have you ever faced the need to identify a primary package for your drug product, but do not know where to start? Are you faced with tight timelines and component data constraints when evaluating stoppers, seals, and vials for container closure systems (CCS)? Do you need the right data for regulatory filing to support the choice of CCS for your drug product?
Ensuring the safe containment of sensitive drug formulations requires a thorough evaluation of the container closure system. Selecting the packaging components requires knowledge about not only the drug formulation's requirements, but also the components’ material properties. Chemical compatibility of components with the drug formulation is key. Proper selection of components will provide the right closure design, assist with handling and help ensure container closure integrity throughout a drug product’s shelf life. Managing these factors well is critical, and West can help.
Most hand-held injectors today are designed for standard drug containers, such as prefilled syringes or cartridges. The primary markets include treatments for chronic conditions such as diabetes and hormone deficiencies where repeat injections are necessary and are administered by the patient or a caregiver.
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