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Critical quality attributes (CQAs) of biologic drug products can be affected by multiple factors throughout the product lifecycle, including the container closure and delivery systems. Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, discussed containment and delivery system compatibility with biologic drug products along with regulatory considerations in her presentation Establishing Safety of Container Closure and Delivery Device Systems at the PepTalk 2017 conference. Evaluating potential impacts early, holistically, and throughout bioprocessing can facilitate decisions at each step that will minimize risks to CQAs and safety.
A number of risks to biologic drug products can arise from poorly understood packaging materials, components, or systems. Examples of risk include: presence of elemental impurities or other leachables, particulate contamination, product aggregate formation, and compromised container closure integrity. Taking a scientific approach to fully understand the chemical characteristics of packaging materials and subsequently evaluating component and system safety in both simulation and actual conditions of use studies will enable the most robust assessment of potential risks to biologic drug products. The presentation also provided an update on the efforts of the Leachables and Extractables Working Group of the Product Quality Research Institute (PQRI).
Please click here to view Ms. Paskiet’s presentation. It is also available in the Knowledge Center of our website.
More information about PQRI can be found here.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
The FDA states: <em>Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* </em>While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
Diane Paskiet will speak at the U.S. Pharmcopeial Convention’s “Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables” Conference, which will be held at USP Headquarters in Rockville, Maryland, on December 9-10, 2013.
<strong>Diane Paskiet</strong>, Director, Scientific Affairs, recently published, “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP),” in the<em>PDA Journal</em>. PQRI is a non-profit consortium involving industry organizations, academia and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality.
The International Conference on Harmonisation (ICH) has issued <em>Guidelines for Elemental Impurities</em> to limit patient exposure to potentially toxic elements above a specified limit during their course of treatment.
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