ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Safeguarding Cell Therapy Cryopreservation: Primary Containers

  Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.

• 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.

• 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.

• Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway

  Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• Enabling Cell Line Tech Transfer For mAb Platform Manufacturing

  Technology transfer, the transmission of bioprocess knowledge, skills, and technology, is a crucial mechanism for ensuring adequate and timely access to innovative medicines.

• Engineering Advances In Needle Geometry To Accommodate Viscous Biologics

  Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.

• A Lifecycle Management Strategy For Sterile Injectables

  Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.

• Q&A: Navigating PFAS In Medical Devices

  Explore how PFAS in medical devices pose environmental and health concerns, prompting regulatory scrutiny.

• NMR And Mass Spectrometry In Pharmaceutical Development

  Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.