Webinar: Surfactants: The Good, The Bad, The Ugly

Date: 20 September 2017 Location: Online Event City: Online Event Country: Online Event

Surfactants are excipients critical to the stability of most biopharmaceutical parenteral formulations. They stabilize proteins in solutions by mitigating potential adsorption and interfacial stress-induced aggregation or precipitation. These interfacial stresses are encountered during many stages of production, shipment and use including: 

 

  • Air/liquid interfaces (e.g. shaking)
  • Ice/liquid interfaces (e.g. freezing and thawing)
  • Surface interactions (e.g. manufacturing equipment) 

 

 

The most commonly used surfactants are the non-ionic excipients, Polysorbate 20 and 80. The mechanism of how surfactants stabilize proteins is not clearly established, but out-competing the protein for adsorption at the interface(s) and thus preventing interface-induced denaturation, is assumed to be the main mode of stabilization.

 

However, the use of polysorbates can also lead to a number of liabilities including adsorptive losses to a variety of materials such as sterilizing filters, and pseudoallergenic reactions (especially in preclinical animal test species). In addition, polysorbates can undergo degradation in bulk raw material (excipient or stock solution) and/or as an excipient in formulated drug substance (bulk) or drug product. Consequences of degradation include:

 

  • Decrease in product stability due to interaction with degradants
  • Generation of particles in the product due to poor solubility of degradants
  • Protein oxidation due to build-up of peroxides

 

To minimize potential issues with the use of polysorbates and to ensure drug product quality, an appropriate monitoring strategy should be put in place during development leading to an overall control strategy.

 

Hosted in conjunction with the American Association of Pharmaceutical Scientists (AAPS), this free webinar will be held Wednesday, September 20, 2017 at 12:30 pm EDT. The webinar will also be available on demand for those unable to attend the live event.

 

Register Here

 

*All attendees must have an AAPS account in order to register. If you do not have an account with AAPS, please click here to sign up.

 

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