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Leveraging AI And Data Science For Biologics Characterization

Modern analytical tools produce more data than we know what do with. Artificial intelligence helps condense, interpret, and utilize what's most meaningful.

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EDITOR'S DESK

Unlocking The Pharmacological Potential Of Antibodies
Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains the company's Functional Antibody Selection Technology (FAST) platform and its approach to developing a pipeline of G protein-coupled receptor (GPCR) mAbs.

Tech Transfer 2025 – A High-Stakes Game Of Trust

Trust us. You'll want to read this editorial from Chief Editor Louis Garguilo, who was (gently) reminded he hadn't visited the subject of tech transfer in a while. He answers the questions both sponsors and CDMOs ask to gain the trust to make a tech transfer work for both sides.

How Lumen Is Putting The "Farm" In Biopharma

Lumen Bioscience's SVP of production and development, Craig Behnke, Ph.D., explains how the company is cutting costs and rethinking upstream manufacturing with its algae-based production platform.

The Safety Potential Of Conditionally Active Biologics

Conditionally active biologics (CABs) are an emerging class of therapies that can reduce off-target toxicity in the clinic, and they were a topic of conversation at the 2025 BIO International Convention.

CDMOs Should Stop Stringing Biotechs Along

Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.

GUEST COLUMNISTS

What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.
How AbbVie's Digital Transformation Brought Platform Knowledge Closer
A custom-built digital ecosystem reduced the time spent on documentation in AbbVie's bioprocess development labs by about 70% for some experiment types.
The New FDA Era Of Radical Transparency And Pervasive Oversight
The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.
A Case Study In Continuous Process Verification
CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.
Optimizing Lentiviral Vectors For Allogeneic CAR-T Manufacturing
A group of graduate researchers explored VSV-G affinity chromatography as an alternative to the standard anion exchange chromatography or AEX.
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."
Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy
Your pharma or biotech company can take these actionable steps to achieve digital facility operations and successfully build your own facility of the future.
New Group Wants 'Phase-Appropriate' Thinking To Retire
Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

BIOPROCESSING WHITE PAPERS

Perfusion Cell Line Development For Intensified Processes
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.

Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
4/28/2025

Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing
4/24/2024

Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
ICH Q12 Implementation: Regulatory Intelligence And PACM Agility
7/9/2024

Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.
Immunogenicity Risk Assessment In Drug Candidate Selection
1/22/2025

Identify and address potential anti-drug immune responses early in development to streamline your drug’s path to clinical success—start smart and finish fast.
Advances In Regulations For Viable Environmental Monitoring
2/21/2025

Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.