Do Changes Signal The End Of Biosimilar Regulatory Redundancy?

First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

ADC Development Grows More Complex — SPR Insights Bring Clarity

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.

New Research: Co-Expression Could Make Plant-Based Systems Viable

By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.

Biopharma Supply, Reimagined: Regional, Resilient Manufacturing

Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.

Can Collaboration Close Biopharma's Talent Gap For Good?

Biopharma innovation is accelerating, but workforce shortages threaten progress. See how strengthening collaboration is essential to developing the skills needed for emerging therapies.

If Collaboration Fuels Biopharma Innovation, Why Can't We Connect More?

Breakthroughs thrive when biopharma teams work across silos, yet collaboration remains surprisingly difficult. Explore the barriers and why they persist. What will it take to move beyond them?

New MIT Consortium Links Innovation With Real-World Biomanufacturing

In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.

Soil Testing: From Filtration To Fertilizer To Food

Soil analysis offers a clear view of the factors that influence land productivity while helping identify contaminants that could threaten safety. Understand the indicators to support sustainability decisions.

If Sustainability Is A Priority, Why Is Progress So Slow?

Sustainability is now central to biopharma strategy. New data reveals why commitments aren’t translating into action, and the roadblocks leaders must address to turn environmental ambition into change.

New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

Building Enterprise Resilience From QRM Signals

Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry

GlycoNex's denosumab biosimilar development experience illustrates how a "just copy it" approach is an insufficient strategy in modern biomanufacturing.

Doubling Up For Speed In Biomanufacturing

Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.

CDMO Or No CDMO... That Is The Question

Success depends on assessing internal capabilities and knowing when outsourcing can accelerate timelines. Learn how strategic decisions reduce risk, avoid costly delays, and keep your organization competitive.

CDMOs - Key Collaborators In Streamlining Drug Development

Accelerating biologics development requires more than speed. Discover how the right CDMO partnership can streamline processes and help you reach the market faster without sacrificing control.

Scaling Up Bioprocesses Through A CDMO

Scaling biopharma processes is complex. Learn how flexibility, single-use systems, and strategic partnerships are helping manufacturers overcome these challenges and accelerate time to market.

5 Reasons For Outsourcing Chromatography Resin Lifetime Studies

Outsourcing resin lifetime studies accelerates timelines, reduces costs, and minimizes risk. Gain expert support, free up resources, and optimize resin performance without tying up your team or equipment.

Is Your Biologics CDMO Transparent?

Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.

How To Double Up With A CDMO To Reduce Risk

Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.

Biologics CDMO: 3 Qualities Often Overlooked

A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.

Product Carbon Footprints: The Next Frontier In Sustainable Innovation

Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.

FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK

The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

New Guide Aims To Build Robust Framework For Digital Validation Tools

The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

Takeda Reimagines Biopharma Quality For The Digital Age

Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

Collaboration An Untapped Fuel For Driving Biopharma R&D

Biopharma’s future depends on collaboration. Discover how cross-industry partnerships and shared resources can accelerate innovation, overcome talent gaps, and strengthen the global R&D ecosystem.

Why Biopharma Breakthroughs Aren't Moving The Market

Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

Optimization And Scale-Up Of A Plasmid DNA Production Process

Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.

A Risk-Based Approach To Plasmid DNA And mRNA Process Development

Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

Take Action On PFAS To Protect Your Critical Processes

PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

Reliably Predicting Biologics Hotspots From Prior Knowledge

Site-specific post translational modifications can seriously affect a molecules stability, function, and structure. These modifications are commonly called "hotspots."