Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.
- Incorporating AI Tools Into Downstream Process Optimization
- A Road Map For PAT Monitoring And Control
- Is Early Automation The Key To Scalable Cell Therapy Manufacturing?
- Hard Lessons In Parenteral Automatic Visual Inspection
- The EU Biotech Act Has Been Delayed — Here's What That Means
- From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
- Addressing Human "Error" In Pharma Manufacturing
EDITOR'S DESK
-
From BPI West: Key Challenges And Benefits Of Continuous Manufacturing
Continuous manufacturing was a hot topic of conversation at this year's BPI West. AstraZeneca's Ken Lee, Ph.D., weighs in during an exclusive interview with Bioprocess Online.
Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.
Bioprocess Online and Cell & Gene spoke with Takeda’s Amy Shaw at BPI West to discuss the industry and her key takeaways from the conference.
Bioprocess Online asked Nathan Lewis, Ph.D., to briefly explain the research he presented at BPI West 2025.
Editor Tyler Menichiello reviews the most compelling topics and sessions from this year's BioProcess International U.S. West.
GUEST COLUMNISTS
-
Incorporating AI Tools Into Downstream Process Optimization
Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.
-
A Road Map For PAT Monitoring And Control
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
-
Is Early Automation The Key To Scalable Cell Therapy Manufacturing?
Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.
-
Hard Lessons In Parenteral Automatic Visual Inspection
Complex problems can have simple solutions. That's what a team at AstraZeneca found when they set out to reduce false rejection rates in vials containing mAbs.
-
The EU Biotech Act Has Been Delayed — Here's What That Means
First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.
-
From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
-
Addressing Human "Error" In Pharma Manufacturing
Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.
-
Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis
Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.
BIOPROCESSING WHITE PAPERS
-
Leveraging Life Sciences Data For Intelligent Decision-Making
Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.
-
Perfusion Cell Line Development For Intensified Processes5/5/2025
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
-
Establishing Commercial Manufacturing Services For ADCs6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
-
Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks9/11/2023
Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.
-
A Scalable Single-Use Two-Step pDNA Purification Process3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
-
Assuring Multipotency Of Human Mesenchymal Stem Cells (hMSCs)4/4/2025
Stem cell research has revolutionized tissue repair and regenerative medicine. Discover how mesenchymal stem cells play a key role and offer insights into connective tissue repair, immune response, and inflammatory diseases.
BIOPROCESSING APP NOTES & CASE STUDIES
- Enhancing Process And QC For Multi-Column Chromatography
- Using Automated Spinoculation For CAR T Cell Lentiviral Transduction
- Bioreactor Scalability Supports Intensified Upstream Process Development
- Simplifying Large-Scale Single-Use Filtration With A Novel Modular Approach
- Evaluating The Corning® CellCube® System
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
- PUPSIT Without The Pain: Practical Solutions For Implementation
- Accelerating Technology Transfer Through Unified Recipe Management
- CLD To Upstream Optimization: Enhancing Biologics Quality, Productivity
- Measuring Thermodynamic Parameters In The Drug Development Process
- Closed System And Custom Solutions For Bioproduction
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 05.12.25 -- Pharmaceutical Facility Monitoring Resources You Shouldn't Miss
- 05.12.25 -- Scalable, Compliant Microbial Manufacturing—Without The Risk
- 05.12.25 -- Common Manufacturing Challenges For LBP Formulations
- 05.10.25 -- Bioprocess Online Best Of April
- 05.09.25 -- STREAM Edition: Biosimilars Are Booming: The Current Landscape