Industry Insights

81. Shaping Biotherapeutics Development Programs Around Different CMC Paths

    As protein engineering and manufacturing technologies evolve, there's a need for flexible, customized strategies to accelerate drug development and approval of biotherapeutics.

82. Save Time And Money On Turn-Over Packages, Pre-Validation, And Factory Acceptance Testing 1/14/2013

    Documentation developed, information collected, and labor expended to create a turn-over package (TOP) for a biopharm modular system represents a significant cost to any project. So much so, that when working with a client, we jokingly say “we sell documentation and you get the system for free.”  To properly validate a system, you have to make the investment in documentation, but you can realize significant labor and cost advantages when developing TOP documentation and pre-validating your modular system via Factory Acceptance Testing in a closed-shop environment. By Mark McGlynn, President, IPEC

83. Commercial Vs. Technical Priorities: The PM High-Wire Act 2/21/2024

    PMs must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

84. Meeting Stability Testing Expectations In A Complex Pharma Landscape

    What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

85. Expedite Commercial Launch Readiness For ADC Manufacturing

    An effective strategy will reduce the probability of late-stage process, analytical, or manufacturing site changes which could put chemistry, manufacturing and controls (CMC) activities on the critical path.

86. Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation 1/16/2025

    API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.

87. Comparing In-house Vs. Outsourced Manufacturing Strategies For CGTs 10/7/2024

    Each approach has its advantages and drawbacks. This guide should help you decide which one, or perhaps a hybrid strategy, is best for your company.

88. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

    The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.

89. Fast-Track Development Of MSC-Based Cell, Extracellular Vesicle Therapies

    Mesenchymal stem cell (MSC) development is accompanied by several challenges related to adequate characterization, regulatory adherence, and balancing upstream and downstream development considerations.

90. Cell Therapy: Process Design Considerations To Support Commercialization 3/28/2017

    Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.