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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.

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EDITOR'S DESK

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.

Single-Use Standardization Starts At Home

During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.

GUEST COLUMNISTS

It's Not Just You, Everyone's Talking About OPV
Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.
Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs
This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.
Global Implications Of Zero Tariffs On Indian Pharma Exports To China
Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.
Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.
Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.
The Transition To E-Labeling Is More Than Uploading PDFs
Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.
Are You Still Evaluating CMOs When You Really Need A CDMO?
Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

BIOPROCESSING WHITE PAPERS

Perspectives On The Adoption Of Fully Closed Processing
In this study, industry experts share their perspectives and plans related to the implementation of fully closed processing. Explore the drivers and challenges of fully closed processing and more.

Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
10/22/2024

Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
Normalized Data In Microbial Continuous Monitoring
7/24/2025

Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.
Elevating mRNA Manufacturing Toward GMP-Readiness
8/27/2025

The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.
Driving Operational Excellence Using Machine Learning
12/13/2024

Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.
Computational Fluid Dynamic Characterization Of Vertical-Wheel Bioreactors
3/6/2025

Explore how computational fluid dynamics (CFD) characterize and scale-up vertical-wheel bioreactors, optimizing hydrodynamic conditions for effective induced pluripotent stem cell (iPSC) culture.

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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.