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Process Engineering's Key Role In Sterile Injectable Facility Design

Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

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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FDA Releases Draft Guidance To Accelerate Biosimilar Development
New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

Supporting The Next Generation Of ADCs

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."

The 9 Fastest-Growing Outsourcing Segments

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.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

GUEST COLUMNISTS

A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.
Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.
Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset
Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.
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."

BIOPROCESSING WHITE PAPERS

Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1
Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization
8/15/2025

Discover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.
Strategic Hiring For Scalable Success
1/22/2026

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.
The Evolution Of Antibody-Drug Manufacturing
6/3/2024

Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing
2/11/2025

Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.
Leveraging Digitalization To Resolve CGT Manufacturing Challenges
2/12/2025

Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.

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BIOPROCESSING APP NOTES & CASE STUDIES

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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.