An interview with Jacqualyn Schulman, Ph.D., a principal scientist at Bristol Myers Squibb (BMS), on her presentation at BPI 2026, “Fast-Tracking CHO Cell Line Development Using Integrated Engineering Strategies.”
- DEA Reveals Hidden Costs Of Analytical Validation Guidelines
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing
- CDMO Selection Beyond Capabilities And Price
- August 2026 — CDMO Opportunities And Threats Report
EDITOR'S DESK
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Evaluating The Levers Driving Productivity In Bioprocessing
Experts discuss where productivity gains can be achieved and how development teams should seek to improve process performance in this recap of the Bioprocess Online Live event "The Levers And Tradeoffs That Drive Process Productivity."
Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.
ADCs built on proprietary platforms risk losing process-specific knowledge during a tech transfer. See what advice panelists from the Bioprocess Online Live event "Ensuring Successful Technology Transfer In ADC Development" shared with the audience on preserving this implicit knowledge.
AP Biosciences’ VP of antibody discovery, Jhong-Jhe You, Ph.D., explains the key design elements of multispecific antibodies and how they affect product developability.
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.
GUEST COLUMNISTS
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Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
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FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
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Engineering Better ADCs, Part 2: Characterization, CMC, And More
Let's take a closer look at antigen selection and tumor biology, PK and PD, analytical characterization, CMC, toxicity, and more.
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CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
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August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions
A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.
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Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More
The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.
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Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
BIOPROCESSING WHITE PAPERS
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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Unlocking The Full Potential Of Antibody-Drug Conjugates (ADCs)6/15/2026
ADCs are evolving rapidly. Gain insight into how success now hinges on managing complexity, delivery, and scalability to turn promising designs into viable therapeutic products.
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End-To-End Process Scalability Of HEK 293 Media For High Titer AAV Production6/2/2026
Explore how controlled bioreactor environments enable optimization of critical process parameters and support robust, scalable AAV production from development through manufacturing.
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Validation And Qualification Approach In New Annex 1 Revision2/21/2025
The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
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Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability10/16/2024
Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based antibody drug conjugates and enhance ADC development processes.
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ADC Development Grows More Complex — SPR Insights Bring Clarity4/14/2026
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
BIOPROCESSING APP NOTES & CASE STUDIES
- On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD
- AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing
- Prioritizing Quality Over Everything
- Evaluating The Levers Driving Productivity In Bioprocessing
- Overcoming Recovery Challenges In AAV Production
- Preserving Tacit Knowledge In ADC Tech Transfers
- Multispecific Manufacturability Starts With Molecular Design
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Editorial Collections are subscriber-only, curated resources that combine expert interviews, feature articles, and industry analysis to help readers better understand emerging trends, operational challenges, regulatory developments, and best practices shaping the biopharma industry.
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ON-DEMAND WEBINARS
- Determining ADCs Positional Isomer Distribution With Nonreduced CE-SDS
- Developing Custom GMP Lipids: A Patient-Driven Partnership
- Smarter Lead Selection And Faster Representative Material
- Beyond Fed-Batch: Choosing The Right Path To Process Intensification
- Accelerating CHO Media Development: From Screening To AI Design
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 10.10.26 -- Bioprocess Online Newsletter - September
- 10.09.26 -- Growing And Scaling A Radiopharmaceuticals Company With AdvanCell's Philina Lee, Ph.D.
- 10.09.26 -- Evaluating The Levers Driving Productivity In Bioprocessing
- 10.08.26 -- What Does Digital CMC Maturity Look Like?
- 10.08.26 -- Streamline Lead Selection & Optimization For Cell Therapy Development
