Drug Development Applications & Studies
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Lift Your CLC Expectations To A New Level
9/11/2023
Using transposon technology, a substantial improvement can be achieved by pseudo-targeting DNA cargos to integration sites where recombinant protein expression is likely higher in various cell types.
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Accurate HC-LC Pairing And A Close-To-Nature Solution For bsAbs
9/11/2023
Examine how a proprietary technology ensures high levels of accurate HC-LC pairing without detriment to critical quality attributes such as titer, binding affinity, stability, and immunogenicity.
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Optimizing The Formulation For A Monoclonal Antibody
8/21/2023
An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.
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The Flux Performance Of Nanoformed And Untreated PRX Solid Suspensions
7/26/2023
Explore the application of in vitro flux assays to nanoparticles, with data on how the in vitro permeability apparatus can characterize the membrane flux performance of an API formulated as a nanosuspension.
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Development Of A Downstream Processing Platform For AAV
7/24/2023
There is a growing need for innovative solutions that reduce costs while maintaining high product quality. This poster presents investigations to derive an economic and scalable method for purification of AAV.
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Applying A Platform Approach To Bispecific Antibody Development
6/16/2023
Explore how experts were able to adjust a mAb production and purification platform to be applicable for the rapid development and scale up of a BsAb.
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Biotech Files NDA Following Risk-Based Mock Inspection
6/14/2023
See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.
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Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour
6/1/2023
A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.
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AAV Full/Empty Capsid Separation Using Mechanistic Modeling
5/1/2023
In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl2 is used as an elution additive.
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Alkaline Stability Of Fc And VH3 Binding In Protein A Resins
5/1/2023
In this study, we looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP).