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March 18, 2021
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   [Free Webinar] NAb-bed Again! – Avoiding Pitfalls During Immunogenicity Studies and How the Right CRO Can Help

Given that the host immune response may be triggered by the AAV vector capsid, the therapeutic gene/ RNA, and the translated protein, a multi-tiered approach is required. There are numerous challenges in developing ADA tests. These include: selection of the optimal methodology, choice of cell line for NAb assays, determining the cut-off point, and utilizing appropriate positive and negative controls. Here we share our experience in working with sponsors to overcome these challenges and discuss relevant criteria when selecting a CRO partner.

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» Industry News
 
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» Featured Articles
Gene Therapy and Mycoplasma: Using Droplet Digital PCR to Precisely Detect Contaminants and Protect Patients
Gene therapies have the potential to bring about the greatest change in medicine since the advent of antibiotics. In 2017, the US Food and Drug Administration approved a gene therapy for the first ... read more »
A Digital Shift in Communications Helps Pharmaceutical Manufacturers Operate at Pandemic Speed
As biopharma companies race to develop drugs and vaccines at “pandemic speed,” quality control strategies and shift-to-shift communications must keep pace. It is all about managing people, processes, ... read more »
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» Featured Partners
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  End-to-end Biologics Drug Development

Know more about our integrated, end-to-end drug development solutions to support you from biologicals DS to finished product read more »
» Featured Video
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  Interphex Live 2020: CMO/Sponsor Relationship
Interphex Live 2020: CMO/Sponsor Relationship read more »
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  On-Demand Webinar: The ABCs and 123s of the BCS
On-Demand Webinar: The ABCs and 123s of the BCS read more »

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» Featured Whitepaper
Is Wurster Processing the Right Choice for My Multiparticulate Modified Release Dosage Form?
Wurster processing is a versatile pharmaceutical development and manufacturing technique for producing multiparticulate modified release dosage forms.... read more »
How Molded Manifold Assemblies Prevent Leaks and Costly Consequences
Traditional fluid transfer systems for biopharm and pharmaceutical applications rely on a multitude of complex components to move liquids from one ... read more »
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| Events
EVENT
  Pre-Filled Syringes East Coast 2021
Virtual –  04/26/2021
SMi are proud to announce the 8th Pre-filled Syringes East Coast virtual conference taking place on 26th and 27th April 2021. event details »
EVENT
  Compounding Pharmacy Compliance
Virtual –  06/16/2021
The go-to event for compounding professionals, Compounding Pharmacy Compliance will take place June 16-17, 2021 in a fully virtual format to assess ... event details »
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