Search results for " assays"
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Getting it Right from the Start in the Drug Development Process
Click here to read more on how the use of surface plasmon resonance (SPR) technology may add value in drug development and how SPR assays are validated and implemented in regulated workflows.
Article
Are You in Control of the Quality of Your mAbs?
Stuart Knowling from Antibody Analytics presented how the latest innovation in surface plasmon resonance (SPR) technology has been adopted to develop and qualify assays for monoclonal antibodies (mAbs…
Article
Nurturing Knowledge from Disparate Data Streams
Structural assays are often augmented with behavior immunoassays. All of these data must be ‘assembled’ together to create the complete picture. That can be challenging to do digitally, because orthog…
Article
A Look at the Affinity Chromatography Landscape
Specially designed kits specific for lenti- or adeno-virus count total viral particle load in rapid, no-wash assays.
Affinity chromatography for viruses
Membrane adsorbers with large pores and…
Article
Scaling Up Novel Therapies
“Not only strong process monitoring and control, but highly relevant assays are needed to ensure that clinically relevant product specifications are met. Where these are on-line or at-line, a high deg…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Third, new quality control assays were devised to ensure the absence of contaminating glycosidases and proteases. Finally, enzymes were manufactured under international quality management systems to e…
Poster
A Scalable Adenovirus Production Process
The process has process economical advantages compared with an existing reference process and includes new technologies and convenient and sensitive virus titer assays.
Article
Biopharma Seeks Balance
The panelists noted that analytics will be a key element in development and manufacturing phases and new potency assays are needed.
Regulatory authorities also need to get up to speed. The meth…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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