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Controls for Leachables Studies

Following the completion of the extraction studies on the container closure system, the development team must begin the evaluation of leachables in the final drug product.    Ideally, the leachables study should be performed as part of the self-life stability study on three separate production lots.    When designing the leachables study, the development team needs to consider including a control.   

A proper control is critical for a successful leachables study.   The main purpose of the control is to allow for a quick determination if unknowns are leachables or drug product degradation products.  Leachables methods are usually orders of magnitude more sensitive than the degradation products methods and thus will detect degradation products and impurities that are well below specifications.    Therefore detecting new drug product degradation products during leachables analysis is common.

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Requirements and Considerations for Analytical Methods to Detect Leachables in Drug Products

Following the successful completion of the extraction studies on the container closure system, the development team must now start the process of developing and validating analytical methods for the detection of leachables in the finished drug product.    Regardless of the type of drug product, the development team needs to consider the following:

  • Selection of target leachables
  • Selection of analytical methods and conditions
  • Method sensitivity requirements
  • Drug Product Specific Challenges.

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Common Question about Executing the BPOG Extraction Protocol for Biopharmaceutical Single Use System Components

Let’s face it, the BioPhorum Operations Group (BPOG) extraction protocol for Biopharmaceutical Single Use Systems stinks (professionalism prevents a stronger expletive).  The protocol is labor intensive, presents multiple analytical challenges and can be expensive. Unfortunately, it is not optional. If manufacturers of single-use components want to sell their products into the biopharmaceutical and biotech industries, they must perform the BPOG extraction protocol. The biopharmaceutical and biotech customers (and their regulators) will be expecting it.

To help a manufacturer of single-use components prepare to execute the BPOG extraction protocol, below are the answers to four common questions.

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Analytical Analysis of Rifampin and Minocycline Coated Surgical Meshes

The coating of a surgical mesh with broad spectrum antibiotics has proven in multiple applications to inhibit colonization of bacteria at the surgical site thus significantly reducing post-surgery complications caused by bacterial infections. The most commonly used broad spectrum antibiotics used for this purpose are minocycline and rifampin. While the addition of these antibiotics to the surgical mesh offers significant benefits to the patient, the project teams needs to be prepared for the challenges presented by coating a surgical mesh with antibiotics.

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Meeting The Day-to-Day Challenges in an FDA-Regulated Environment

It may sound trite, but a quality organization must meet the demands set for a quality organization every day. Those of us facing this reality may give a knowing nod and smile upon hearing this obvious fact. Those working at some distance from it may think the statement is just another attempt by the Quality Assurance Unit to blow its own horn. This is a problem, because it is not the Quality Assurance Unit (QAU) that makes a quality organization. Rather, it is management’s commitment to and involvement in quality that rolls everyone up into the quality organization, including of course those identified as working in the QAU.

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Common Question about Extractable and Leachable Requirements for IV Bags and Infusion Devices from Parenteral Drug Manufacturers

Manufacturers of parenteral drugs are familiar with the requirement to perform extractables and leachables testing on the primary container closure systems used with their drug products. These container closure systems often consist of glass or plastic stoppered vials and the contents can be either a liquid, powder, or lyophilized drug product. However, this may not be the only extractables and leachables (E&L) testing requirement if the parenteral drug product is reconstituted and/or diluted in an IV bag of diluent to form an admixture and delivered to the patient by infusion.  Below are some common questions from Parenteral Drug Manufacturers on their requirements to perform E&L studies on IV bags and infusion devices.

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