INSIGHTS ON DRUG DEVELOPMENT

• Achieving A F.A.I.R. Data Management Strategy

  Recently many industry leaders have been highlighting the problems of not having F.A.I.R. data. For example, a recent report estimates that data that is not findable, understandable or has incomplete metadata introduces inefficiencies and negatively impact research quality, ultimately costing the European economy in excess of €26 billion per year. In this white paper, we explore what the F.A.I.R. principles mean in practical terms for your R&D data management strategy before describing how IDBS enables organizations to make their scientific data Findable, Accessible, Interoperable and Reusable and mitigate the costs of not being F.A.I.R.

• Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures

  This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.

• Getting Your Investigational Drug Regulatory Ready

  Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

• Improve Biopharma Fermentation With Innovation, Collaboration

  Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.

• Drug Discovery Workflow For PROTAC With A Focus On Eliminating Bottlenecks In Evaporation

  An emerging modality of therapeutics called PROteolysis TArgeting Chimeras (PROTACs) could enable the design of new drugs targeting “undruggable” proteins, which make up to 85% of the proteome. This article introduces PROTACs and the benefits they can offer to the drug discovery field, before discussing how the issues with their synthesis can be overcome.

• Applying Quality By Design To Pharmaceutical Research And Development

  QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.

• Quality Matters – SEC Analysis For Antibody Aggregates

  Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

• How Can We Predict Immunogenicity Earlier?

  With many biotherapeutics a strong immunogenic response can limit the effectiveness of the treatment or cause a more serious illness. This remains a challenge for scientists as the underlying mechanisms of unwanted immunogenicity still aren’t completely understood. Detecting and preventing unwanted sources of immunogenicity as early in the discovery process as possible has become a top priority for research organizations since biotherapeutic development becomes increasingly costly as it moves downstream.

• Demystifying Highly Potent API And Cytotoxic Drug Products

  The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.