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PDA New England Chapter Webinar: Extractables and Leachables for Biologics

Aug 25, 2021
2:00 PM
-
3:00 PM
| Eastern Standard Time
Online
  • Chapter
  • Online

Overview

Special Note to PDA Members: If you are a PDA member, please ensure that you use the PDA member discount code. If you don't have it, send an eMail to [email protected] or Shanna Morgan requesting it.

Biologics (Large Molecule drugs, Biopharmaceuticals) 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. Biologics are comprised of living cells, proteins, tissues, blood components, vaccines, or gene therapies. The requirements for characterizing these drug forms, including for E&L, is the same as for small molecule drugs. Due to the nature of biologics, most are administered through injection or other parenteral routes. The U.S. Food and Drug Administration (FDA) has categorized parenteral drug forms as having a high concern associated with the route of administration that require leachables testing. Developing appropriate leachables methods for characterizing biologic drug forms presents many challenges over small molecule drug forms. Mr. Hill, an analytical chemist, will present his experience working with these challenging materials, as well as strategies for conducting E&L studies.

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Highlighted Speakers

Eric Hill
Eric Hill
Boston Analytical

Who Should Attend

  • Quality
  • Validation
  • Regulatory 
  • Packaging
  • Manufacturing 

Registration Fees

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Registration Type Price
Member* $25.00
Non-Member $65.00

*A special discount is available for PDA Members. To get this discount code, send an email to PDA Membership Dept: [email protected] or Shanna Morgan, [email protected].

NOTE: When entering a discount code, ensure that all characters are in UPPER case, when applying. Do not cut & paste.

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