INSIGHTS ON DRUG DEVELOPMENT

• Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start

  As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

• What You Need To Know About Process Characterization And Validation For Biologic Processes

  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.

• Sponsor Challenges When Outsourcing Sterile Injectables

  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.

• Expanding SPR Uses In Antibody Effector Function Determination 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.

• Novel Analytics To Improve Bioprocessing And Validation Guideline Review

  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.

• The Physical Properties Of An API And 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.