Liquid Dose Featured Articles

31. EMA Issues New Draft Guideline: Chemistry Of Active Substances 9/3/2024

    The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

32. EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging 8/27/2024

    Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

33. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

34. Developing & Manufacturing Oligonucleotides: An Overview 8/22/2024

    An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.

35. Singota Solutions Showcases Comprehensive Capabilities At Third Annual Capacity And Capability Update 8/21/2024

    Learn more about our expertise in drug formulation development, analytical testing, aseptic filling, pharmaceutical labeling and kitting, and supply chain management.

36. 2024 Emerging Trends In Cleanroom Technologies 8/14/2024

    This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.

37. VR/XR In Drug Manufacturing: No Longer Sci-Fi 8/13/2024

    Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.

38. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

39. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

40. Illuminating The Pathway To Efficient Drug Development For Small Biotechs 7/26/2024

    To guide a biotech through successful drug development, there are three key areas a CDMO should focus on: equipment and instrumentation, organization and personnel, and systems and processes.