Industry Insights
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Tips For Making Better Tech Decisions In Biotech Manufacturing
3/28/2022
As startup pharmas, biotechs, and gene therapy companies, how do we strike the right balance between new technology ROI and its impact on P&L? This article discusses considerations and tips for adopting single-use technologies and deciding when to go digital.
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If Sustainability Is A Priority, Why Is Progress So Slow?
2/10/2026
Sustainability is now central to biopharma strategy. New data reveals why commitments aren’t translating into action, and the roadblocks leaders must address to turn environmental ambition into change.
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Mixing Technology: Linear Scalability And Mixing Precision For Nanoparticle Formulation
8/5/2025
Find out how you can achieve precise control and linear scalability in nanoparticle formulation with mixing technology that minimizes batch-to-batch variability and simplifies the scale-up process.
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The Physical Properties Of An API And Drug Product Performance
An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.
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How To Choose A GXP Electronic System Vendor
3/31/2026
Selecting a GxP electronic system impacts validation timelines and audit readiness. See how purpose-built platforms simplify compliance, while heavily customized generic tools often introduce risk.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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Key Factors To Consider When Selecting A Stereo Microscope
1/8/2024
Utilize this comprehensive guide to choose the right stereo microscope for your application, and learn about the key factors you should consider and analyze.
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A 5-Factor Framework For Successful CMO Partnership
10/31/2024
Identifying manufacturing capacity that can adapt to a growing and changing biopharma landscape requires an emphasis on technical and operational expertise combined with agility and flexibility.
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FDA Updates Guidance For Investigating OOS Test Results
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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5 Considerations For Scaling-Up PSC-Derived Cell Therapies
3/9/2021
For a cell replacement therapy to be successful, you need a significant number of differentiated cells – sometimes upward of 1 billion cells per dose. Since differentiated cells have a limited proliferation capacity in comparison to pluripotent stem cells (PSCs), and some cells may not integrate into host tissue, high doses of cells are needed for cell replacement therapies. Our team has tackled the challenges of manufacturing scale-up for PSC-derived cell therapies numerous times.