How Does SUS Integrity Change Across Drug Product Lifecycle?

Learn how phase-appropriate risk justification, validation, documentation, and lifecycle controls can strengthen sterility assurance while reducing the potential for rework and delays.

Overview Of Single-Use System Integrity Assurance

Single-use system integrity depends on managing risk across the entire life cycle. Explore how materials, packaging, transport, installation, handling, and use influence sterility assurance.

Can Targeted LNP Delivery Take In-Vivo CAR-T Therapy Beyond The Liver?

Achieving successful extrahepatic CAR T delivery with LNPs requires addressing the unique biological and technological barriers and designing targeting approaches that leverage innovative LNP design.

Building Trust In AI For Computerized System Validation

Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

A Gentler Cell Line Selection Method Using microRNA

Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.

Developing Non-PEG Stabilizer Lipids For Nucleic Acid Lipid Nanoparticles

Non-PEG stabilizer lipids may offer a new path for LNP design. Combining strong colloidal performance with greater chemical flexibility helps address growing concerns around PEG-related immunogenicity.

Neoantigen-Based Personalized Cancer Vaccine

Personalized cancer vaccines are advancing quickly, but effective delivery remains a major hurdle. Learn how mRNA and lipid nanoparticle design influence targeting, endosomal escape, and repeat dosing.

Lipid Nanoparticles For Pulmonary Delivery Of mRNA

Gain insight into how nebulized mRNA lipid nanoparticles show preclinical success in lung delivery, offering fresh momentum for inhaled gene therapies targeting respiratory diseases.

Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines

Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

The Invaluable Asset Driving Advanced Therapies Forward

Cell therapies are advancing rapidly, but manufacturing delays still limit patient access. Improving operational understanding, reducing risk, and strengthening collaboration may be just as critical.

A Custom Path To The Clinic: Inside A Collaborative Model

Balancing speed, compliance, and control is no small task. A different approach to external support is emerging—one that prioritizes knowledge transfer, collaboration, and long-term confidence.

Collaborative Supply Chain Management In A Fragmented World

Biopharma supply chains are under pressure. As regionalization accelerates, success depends on agility, trust, and new approaches to collaboration that can withstand ongoing global uncertainty.

What To Do About Process Drift In Your Biosimilar's Reference Product

Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs.

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.