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?

Learn why high-performing filters are inadequate for critical filtration processes and 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.

Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis

This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.

Fab Fragment Development And Manufacturing For Clinical Trials

Explore the outcomes of implementing an accelerated approach to process development and manufacturing for a project that was crucial for the future of Acticor Biotech and its therapeutic candidate.

Revolutionizing Drug Discovery From "Undruggables" To AI

Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

The Growing Demand And Applications For HPLC

High-performance liquid chromatography offers more features compared to other analytical techniques, and the industry is finding more valuable ways to use it.

Overcoming The Solubility Challenges Of Antibody-Drug Conjugates

Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

Efficacy Screening Of Antibody-Drug-Conjugates By Surface Plasmon Resonance

Rapid screening of ADC affinity using surface plasmon resonance provides preliminary efficacy data in comparing antigen binding affinity with selected linkers and payloads to the non-conjugated antibody.

Establishing Commercial Manufacturing Services For ADCs

Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies

The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

Viral Vector Producer Cell Lines: Learning From mAbs

Learn how applying bioprocessing knowledge from the production of mAbs can accelerate the development of viral vector cell lines and improve efficiency in gene therapy manufacturing.

Tips For Viral Vector Production

Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies

Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.

Top Challenges In Recombinant Protein Purification Process Development

Get insights from process developers working with recombinant proteins that cannot be purified with affinity chromatography.

Three Key Considerations For Optimizing Process Development

When it comes to process development, timing, technology, and partners all merit careful consideration. Explore expert insights into these three crucial factors.

Navigating Cell Therapy Process Development

Equip yourself with the knowledge necessary to make well-informed decisions by exploring the main challenges and considerations inherent in cell therapy process development.

Formulation Process And Analytical Development Capabilities

Explore process and analytical development capabilities that can help you advance your formulation to GMP Manufacturing.