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Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk

Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.

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EDITOR'S DESK

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing
At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

The Death Of A Dogma: David Baltimore And Lessons For Modern Drug Discovery

Nobel laureate, David Baltimore passed away at 87 years old, on September 6, 2025. He was widely regarded as a scientific visionary who at just 37, co-discovered reverse transcriptase, an enzyme that flipped molecular biology on its head by showing that genetic information could flow from RNA back to DNA, not just the other way around.

GUEST COLUMNISTS

Here's What You Need To Know About The Access Consortium Pathway
Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.
FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK
The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.
Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
AI Is Not The CMC Revolution You're Looking For, And That's OK
Advanced therapy development today is less about big funding, more about frugality. Artificial intelligence unlocks a competitive advantage.
Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development
The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
How To Improve Sponsor–CMO Collaboration Around Digital Deviations
Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.
Solving The Stem Cell Consistency Conundrum With iMSCs
The ability to produce unlimited batches of induced mesenchymal stem cells from a single iPSC cell bank is, perhaps, one of their most alluring features.
Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach
Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

BIOPROCESSING WHITE PAPERS

Unravelling The Complexities Of ADC Manufacturing
Whether you're in the early stages of development or scaling up for commercialization, understanding ADC manufacturing challenges is essential for bringing life-saving therapies to patients worldwide.

Aggregation In Antibody-Drug Conjugates: Causes And Mitigation
9/1/2025

Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
The Role Of Extractables Data In The Adoption Of Single-Use Systems
8/29/2024

Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
Leveraging Efficiency From CLD To Clinical Manufacturing Of mAbs
4/23/2025

Discover how our efficient strategies can propel your mAb from discovery to clinical manufacturing in as little as 18 months.
Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024

The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
6/12/2025

Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

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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.