Featured Articles

41. Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective 6/22/2020

    This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.

42. Cell Based Potency Assay In Functional Characterization Of mAbs 6/12/2019

    Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

43. De-Risk mRNA Regulatory Approvals

    Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.

44. mRNA Process And Cost Modeling: A Tool To Optimize Process Development

    Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.

45. The Biopharmaceutical Factory Of The Future

    The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.

46. How To Automate Continued Process Verification

    This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.

47. Contrast In Oligonucleotides

    Explore the differences between research-use-only oligonucleotides and those manufactured under GMP-grade ISO 13485.