Haemtech Assay Validated for FDA-Approved IGIV Drug

POSTED on January 15, 2014

Haemtech Biopharma Services Haemtech Biopharma Services’ thrombin generation assay (TGA) was developed to assess the thrombogenic potential of solutions. According to Richard Jenny, HBS’s President and CEO, “There has been an increasing push by regulatory authorities for plasma-based biotherapeutics manufacturers to improve upon methods used to determine the thrombogenic potential of their products. We believe the validation of this assay to be a significant step toward our ability to help all manufacturers meet this goal. We can now use our experience to offer TGA assay development, validation and implementation services to all plasma-derived drug product manufacturers looking to satisfy regulatory requirements”.

Read the press release.

[Part of the Winter 2013 Newsletter, see more in the Archives.]

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