Boston Analytical

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Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, and Extractables & Leachables Studies.

For more information about Boston Analytical, please contact:
Kristin Dangelo
Director of Business Development
Phone: 603-489-8692
Email: kdangelo@bostonanalytical.com

WHITE PAPER

Virtual Audits: Finding opportunity in COVID-19 crisis

August 11, 2020

Qualification audits have always been routine events for life-science companies, such as pharmaceutical manufacturers. For companies that outsource their testing, audits — complete with onsite visits to laboratory facilities — are traditional practice in terms of maintaining Food and Drug Administration (FDA) compliance.

COVID-19’s emergence meant an alternate to the onsite qualification audits was needed. In a surefire case of good emerging from a bad situation, even further value developed from a new audit method.

But first: Why do we audit pharmaceutical-testing firms?

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WEBINAR

Extractables & Leachables for Biologics

August 25, 2020

Large Molecule drugs, Biopharmaceuticals, or Biologics are a growing class of drugs in the Pharmaceutical industry. These drug forms include pharmaceutical products that are manufactured in, extracted from, or synthesized from biological sources. These drug forms offer the ability to treat medical conditions that traditional “small molecule” drug forms cannot. Biologics are comprised of living cells, proteins, tissues, blood components, vaccines, or gene therapies. The requirements for characterizing these drug forms during development and manufacture is the same as for small molecule drugs. This includes the evaluation of extractables and leachables for the container closure system and/or delivery system. Due to the nature of biologics, most are administered through injection or other parenteral route. The U.S. Food and Drug Administration (FDA) Guidance for Industry has categorized parenteral drug forms as having a high concern associated with the route of administration. The FDA has specifically requested leachables studies be performed for parenteral products. Leachables testing involves analyzing the drug product during storage in its container closure system for leachable compounds from the container closure system materials. Developing appropriate leachables methods for characterizing biologic drug forms presents many challenges over small molecule drug forms. Boston Analytical will present our experience working with these challenging materials, as well as strategies for conducting E&L studies.

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We’d love to hear from you! Whether you have a question about white papers, webinars, or anything else, our team is ready to answer all your questions.