At the 2026 BIO International Convention, Bioprocess Online caught up with Johanna Kaufmann, Ph.D., CSO at Deck Bio, a company developing multi-targeted T-cell engagers for solid tumors.
- BIO 2026: Crowley On Competing With China And Modernizing The FDA
- Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
- An Open-Source Modeling Tool For Suspended Continuous Lyophilization
- Essential CMC Elements For A Therapeutic Secretome
- Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
- How To Avoid The Biggest USP <665> Compliance Trap
EDITOR'S DESK
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Essential CMC Elements For A Therapeutic Secretome
Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.
This article summarizes the major developments and industry pressures highlighted by Life Science Connect editors in the "Better Biopharma" midyear editorial roundtable.
Bioprocess Online's Editorial Advisory Board responds to former FDA commissioner Marty Makary’s resignation amid a prolonged period of instability at the agency.
Audience polls and expert insights reveal insufficient vendor data as the main bottleneck stalling advanced single-use technology adoption. Explore that and other key takeaways in this recap of the Bioprocess Online Live event on "Closing The Adoption Gap For Advanced Single-Use Materials."
Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.
GUEST COLUMNISTS
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An Open-Source Modeling Tool For Suspended Continuous Lyophilization
Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.
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Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines
Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.
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How To Avoid The Biggest USP <665> Compliance Trap
U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.
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Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.
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FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.
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Solving Glycoengineering Challenges Could Begin At The Cell Line
Researchers produced a panel of platform cell lines illustrating how glycoform selection can be made experimentally visible earlier in biologics development.
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What Biopharma Often Overlooks In A Scheduled Shutdown
Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.
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Organizing Digital Systems Around Novel Modalities
Cell therapies represent an important advancement in our ability to treat difficult cancers, but continued exploration of this new modality will require new digital tools and equipment.
BIOPROCESSING WHITE PAPERS
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Single-Use Technology And Environmental Responsibility In Biopharmaceuticals
Learn about strategies such as regional manufacturing and advanced single-use systems and their potential to minimize carbon footprint and enhance sustainable biomanufacturing.
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Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S112/10/2024
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.
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The Current And Future Value Of mRNA Vaccines And Therapeutics2/4/2026
Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
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Strategic Hiring For Scalable Success1/22/2026
Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.
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Improving API Solubility3/3/2025
Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.
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From Process Monitoring To Manufacturing Intelligence: Real-Time Analytics And Predictive Control In Biomanufacturing6/19/2026
Advanced analytics, predictive modeling, explainable AI, and digital twins are helping biomanufacturers improve process visibility, anticipate outcomes, and support smarter operational decisions.
BIOPROCESSING APP NOTES & CASE STUDIES
- Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines
- Novel Technique Advances Super-Resolution Thermoreflectance Microscopy
- Monitoring Of A pH Optimization Approach For CHO Cell Cultivation
- Using Precision Fermentation To Produce Animal-Free Milk Proteins
- Development Of An Effective LC-MS/MS Cleaning Validation Method
- On The Ground At BIO 2026: Johanna Kaufmann, Ph.D., On The Oncology Modality Puzzle
- BIO 2026: Modernizing The FDA And Bolstering The Workforce
- BIO 2026: Crowley On Competing With China And Modernizing The FDA
- Essential CMC Elements For A Therapeutic Secretome
- Midyear Pulse Check: What's Shaping Biopharma In 2026?
- Reflecting On Continued Turbulence At The FDA
- Insufficient Vendor Data Is Hamstringing Single-Use Adoption
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Lyophilization Excellence: Partnering For Sterile Fill/Finish Success
- Reducing Particulate-Related Batch Risk In Bioprocessing
- Transitioning From 2D To 3D: Getting Started With Spheroids
- Residual DNA Testing Across Biotherapeutics
- Breaking the Titer Ceiling: Smarter Media Design for Higher Productivity
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 07.10.26 -- STREAM Edition: Automation's Role In Optimizing Viral Vector Recovery And Reduce COGs
- 07.10.26 -- Essential CMC Elements For A Therapeutic Secretome
- 07.09.26 -- Why Contamination Control By Design Still Falls Short In CDMOs
- 07.08.26 -- Considerations For Scaling Downstream Viral Vector Manufacturing
- 07.07.26 -- Manufacturing Insights for Large Molecule Development