Insights On Drug Development

1. What You Need To Know About Process Characterization And Validation For Biologic Processes 4/3/2020

   Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

2. Sponsor Challenges When Outsourcing Sterile Injectables 4/3/2020

   ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

3. Expanding SPR Uses In Antibody Effector Function Determination 2/25/2020
   SPR can be implemented at early stages in screening and testing strategies in order to provide better, faster, and stronger analysis of drug candidates. In order to minimize risk and to get “true” affinity in binding analysis, we have adopted the latest innovation in surface plasmon resonance (SPR) technology, Biacore™ 8K, to develop and qualify assays for monoclonal antibodies and other therapeutic proteins to ensure all critical quality attributes are set and controlled with accuracy and precision.
4. Novel Analytics To Improve Bioprocessing And Validation Guideline Review 2/25/2020

   A thorough understanding of how the process impacts the product quality attributes is essential for decision-making. Implementation of a robust analytical control strategy with information-rich technologies has the potential to significantly improve characterization and productivity. This presentation will provide an overview of how innovative protein analysis tools have been adopted for better comparability, release testing, and impurity monitoring.

5. The Physical Properties Of An API And Drug Product Performance 2/14/2020

   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.

6. Streamlined High Performance Extraction And Quantitation Of Host Cell Residual DNA In Bioproduction 2/12/2020

   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.

7. Leveraging Media And Supplements For Desired Protein Glycosylation 2/12/2020

   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.

8. Advantage Of Antibody Based Selectivity In The Purification Of Biologics 2/11/2020

   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.

9. Subdomain-Specific Affinity Ligands Accelerate Antibody Drug Development 2/7/2020

   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.

10. Principles Of Immunogenicity Assessment Using Biacore T200 SPR System 2/4/2020

    Usually, ligand binding technologies such as ELISA are used for early immune responses, whereas SPR technology is utilized for the characterization of antibody isotypes.