INSIGHTS ON DRUG DEVELOPMENT

• Understanding The Physical Properties Of An API And Their Effect On Drug Product Performance

  An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

• Streamlined High Performance Extraction And Quantitation Of Host Cell Residual DNA In Bioproduction

  Residual host cell DNA is a common process-related impurity that is typically co-monitored with host cell protein. Here we report on high performance Host Cell Residual DNA extraction and quantitation using a streamlined and high throughput semi-automated workflow.

• Leveraging Media And Supplements For Desired Protein Glycosylation

  Obtaining desirable and consistent monoclonal antibody (mAb) protein quality attributes, such as glycosylation, is critical in today’s bioproduction industry, especially for biosimilar molecules. This poster highlights a case where we use high throughput screening (HTS) to evaluate mAb production and glycosylation for a Chinese hamster ovary (CHO) cell line in a chemically defined (CD) media panel.

• Advantage Of Antibody Based Selectivity In The Purification Of Biologics

  Advances in bio-therapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges. By taking advantage of antibody based selectivity, Camelid heavy-chain antibody fragments (VHHs) have proven to be a reliable immuno-affinity chromatography (IAC) solution in the downstream process of biologics.

• Subdomain-Specific Affinity Ligands Accelerate Antibody Drug Development

  Development of novel bio-therapeutic antibody formats creates purification challenges in downstream processes. New tools aid the discovery and manufacture of therapeutic antibodies and antibody fragments.

• Principles Of Immunogenicity Assessment Using Biacore^TM T200 SPR System

  The assessment of unwanted immunogenicity is a key parameter in the development process of biological protein drugs. Usually, ligand binding technologies such as ELISA are used for early immune responses, whereas SPR technology is utilized for the characterization of antibody isotypes, which may be important for the interpretation of the clinical consequences of unwanted immunogenicity.

• Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply Chain

  To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route for drug substance, drug product, and clinical trial packaging needs.

• Advanced Analytical Tools For Drug Product Development

  Gain insight into analytical techniques that reveal answers during product development, with an emphasis on Raman spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, and mass spectrometry (MS).