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Diane Paskiet, 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 thePDA Journal. 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.
This article provides an overview of extractables and leachables in drug products and biologics, and discusses the PQRI Work Plan and Protocols developed by the PQRI Parenteral and Ophthalmic Drug Products Leachables and Extractables Working Group.
Read the full text here: http://journal.pda.org/content/67/5/430.full
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase <a href="/products/vial-containment-solutions/stoppers/4040-lyotec-lyophilization-elastomer-stoppers">lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation</a> that can be paired with any vial blowback geometry.
Regulatory and market expectations constantly increase. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. One aspect of this is controlling particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. This blog describes approaches to control and measure particulate matter.
Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986.<sup> [1]</sup> With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. <sup>[2]</sup>
The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”
“Waiter, what’s this fly doing in my soup?”<br>Answer: “The backstroke”
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