Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
- Thoughtful Supply Strategy Is No Longer Optional In Drug Development
- Active Versus Passive Shipping Solutions For Clinical Shipments
- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
- January 2026 — CDMO Opportunities And Threats Report
- This Industrial Fungus Has Protein Expression Promise For Pharma
- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
- Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
EDITOR'S DESK
-
FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.
Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."
Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.
At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.
AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.
GUEST COLUMNISTS
-
Thoughtful Supply Strategy Is No Longer Optional In Drug Development
In drug discovery and development, supply chain decisions are often treated as a downstream concern. In reality, supply strategy is a development decision from the very beginning.
-
Active Versus Passive Shipping Solutions For Clinical Shipments
Explore active and passive temperature-controlled shipping solutions and their impact on clinical trial supply, balancing cost, risk, and product integrity.
-
The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."
-
January 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.
-
This Industrial Fungus Has Protein Expression Promise For Pharma
Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.
-
Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
Cell and gene therapies share fundamental objectives with conventional biologics. Their common challenges offer a natural starting point to solving downstream bottlenecks.
-
Real-World Phase-Appropriate Control Lessons For mAb/ADC Manufacturers
Effective mAb and ADC manufacturing control strategies evolve through the phases. These four principles should guide your strategy design as goals shift.
-
High Specific Productivity For Leaner Sustainable Bioprocessing
Improving specific productivity moves the goal beyond pumping out higher titers, but it demands a deeper understanding of cellular biology and protein expression.
BIOPROCESSING WHITE PAPERS
-
Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
-
Understanding Potency In Gene Therapy Development2/28/2024
Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.
-
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.
-
Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy2/6/2026
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
-
Building Local Biomanufacturing Capacity In South Africa2/11/2025
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
-
Beyond Glycan Control: The IVGE Advantage In Key Biopharma Applications12/18/2025
In Vitro Glycoengineering (IVGE) precisely controls glycosylation to optimize biopharma workflows, serving as a critical platform for advancing key therapeutic areas in today's industry.
BIOPROCESSING APP NOTES & CASE STUDIES
- Practical Considerations For Aseptic Gowning In Contamination Control Strategies (CCS)
- Viral Clearance Under Mild pH Using Protein A Resins
- A Toolkit For Unraveling Protein Expression Patterns
- How A Pharma Company Improved Yield By 1.5% In Just Three Months
- Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges
- Taking The First Steps Towards Digitalizing Biopharma Development
- Bioprocess Online's 2025 Editorial Reflections
- FDA Releases Draft Guidance To Accelerate Biosimilar Development
- Supporting The Next Generation Of ADCs
- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
- On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration
- On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing
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
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 02.18.26 -- Leveraging Conventional Therapeutics Skills For Cell And Gene Therapy
- 02.17.26 -- Reducing Risk And Increasing Throughput In Modern Bioprocessing
- 02.17.26 -- How Will U.S. Tariffs And The BIOSECURE Act Impact Global Biopharma Markets?
- 02.16.26 -- Filtration Solutions For Every Bioprocessing Scale
- 02.16.26 -- Accelerate Batch Release With Agentic AI: Turning Data Into Actionable Insight