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?"

Multi-Attribute Method Analysis In Biopharmaceutical Development

Analytics is a crucial element in biopharmaceutical development and manufacturing. Discover how Multi-Attribute Method (MAM) revolutionizes analytics to enhance quality control and regulatory compliance.

Emerging Trends In mAbs Manufacturing In 2025 And Beyond

Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing.

Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars

With an projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.

Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

Optimize Your RFP To Ensure Successful Biologic Development

Creating a thorough, comprehensive RFP will help a CDMO partner lay the foundation for a productive partnership, fulfill your goals, and help ensure future market success for your therapeutic.

Choose The Right CDMO To Guide Your Biologic To Regulatory Success

If you are wondering when to begin your CDMO search, the answer is simple: the sooner the better. Partnering with a CDMO early helps ensure later success.

3 Ways To Maximize The Benefits Of Your CDMO Partnership

An experienced CDMO partner can help bridge the gap from lab scale to clinical and commercial scale while sharing the critical insights needed to launch a biologic manufacturing program.

End-To-End Analytical Solutions For Biologic Development

Partner with Mabion for comprehensive, state-of-the-art analytical services that ensure quality, safety, and regulatory compliance throughout every stage of your biologic drug’s lifecycle.

From Tech Transfer To Validation: One CDMO's Client-Centric Approach To Development

If you’re looking to work with a CDMO that can help you save money and ensure efficiency in your therapeutic production, consider the benefits of choosing a Polish partner.

The Crucial Role Of Downstream Processing In Optimizing RNA-LNP Drug Development

Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.

Drug Product Formulation & Process Development: The Must-Have Skills At A Glance

Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

Business Continuity Management: The Benzonase® Endonuclease Success Story

Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.

Is Your Lab Ready For A LIMS Implementation?

Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.

Is Industry Ready To Take A Bite Out Of Obesity?

What are the clinical, economic, and policy considerations for a class of drugs offering a promising treatment for obesity, and how is the industry adapting to meet demand?

New And Upcoming Trends In Immunodiagnostics

Explore the latest trends and cutting-edge technologies in immunodiagnostics that are transforming disease detection.

When Measuring Filter Performance, Is Performance Absolute?

See why high-performing filters are inadequate for critical filtration processes and why sterilizing-grade filters are necessary to effectively remove undesirable species, including bacteria and viruses.

Optimizing Virus Filtration Validation

Explore guidance regarding the effective validation of a virus filtration process in the laboratory, including the fundamentals of viral filtration and an examination of relevant regulatory guidelines.

Raman As A Quality Control Tool For Cell Culture Media Preparation

Explore study results demonstrating how Raman technology easily differentiates between media with similar compositions and detects potential preparation errors that other analysis methods might miss.