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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

A Checklist For Efficient And Reliable Gene Therapy Manufacturing
Gain insight into how to design and execute an efficient upstream AAV production process, and follow the checklist within to ensure all appropriate factors are considered at each phase of drug development.

ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
3/11/2025

Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
Factors To Consider While Selecting Stoppers For Lyophilized Vials
10/16/2024

Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.
Extractables And Leachables Assessment For Single-Use Systems
4/14/2025

Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.
The Benefits Of Incorporating Lean Methodologies Into Project Management
8/20/2024

Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.
Support Of Scale-Up And Technical Transfer Through Understanding Equipment
10/16/2024

See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

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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.