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.

Should We Refocus On The Product, Then Engineer The Process?

Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

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."

Navigating The Regulatory Space To Biosimilar Approval

The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

Aggregation In Antibody-Drug Conjugates: Causes And Mitigation

Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

The Building Blocks Of A Robust Analytical Assay

Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

Overcoming Gene Therapy Cost Roadblocks On The Path To Patients

Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

Viral Gene Therapy: Reducing Costs To Improve Patient Access

Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

3 Key Considerations In Gene Therapy Manufacturing

Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

Ready To Demystify Organoids?

Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.

Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing

Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.

Scope 3 Emissions: A Shared Challenge, A Collective Responsibility

Despite growing sustainability efforts, our industry lags in climate goals, especially Scope 3 emissions. Discover why bold action and deep collaboration across the value chain are essential for real progress.

Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services

The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

First AMT Program OK'd Under New FDA Designation — Here's What To Know

The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

Formulation Is Key For Y-mAbs' Self-Assembling Antibody

The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

Nanomedicine Modalities Find Path To Clinic Through Analytics

Lipid nanoparticles have revolutionized drug delivery, ushering in a new era of nanomedicine. Discover how advanced analytical tools are accelerating next-generation LNP therapeutics.

Using AI To Predict Multispecific Formulation Patterns

This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

ADCs: The Next Phase Of Innovation

Explore the pivotal advancements in ADCs that focus on high-DAR, multispecific designs, and novel payloads, while addressing challenges in manufacturability, scalability, regulatory acceptance, and commercial viability.

Indian Biosimilar Companies Are Poised To Succeed In The Global Market

For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines

Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

Thunderstruck By Antibody-Drug Conjugates

Antibody-drug conjugates are transforming cancer treatment by targeting tumors directly to reduce side effects. Discover how they affect neighboring cells, which can enhance treatment efficacy and eliminate tumor cell populations.

The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance

Joseph Pategou asks and answers, "Where does the U.S. biosimilar market stand now?"