ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Effects Of Annex 1 Revisions On Manufacturing Operations

  The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.

• Contract Design And Development Vs. In-House: How To Find The Best Fit

  Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.

• Achieving EU GMP Annex 1 Compliance For Contamination Control

  Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

• Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

  This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

• Addressing Glass Particulates In Injectable Drug Formulations

  Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

• Understanding Of Amorphous Solid Dispersions & Their Downstream Development

  Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• Stability Chambers: Testing, Equipment, And Uses

  Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

• Mitigating Hidden Risks: Extractables And Leachables

  Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

• Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

  Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.