Bioprocess Online for bioanalytics, biopurification, bioproduction

new opportunity, bright future-GettyImages-1477131816

Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities

The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

More Featured Editorial

EDITOR'S DESK

Lonza Bets On Biologics. What's It Mean For You?
It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry?

BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use

Bioprocess Online chief editor Tyler Menichiello shares his three key takeaways from the 2025 BIO International Convention.

Analytics And Cross-Functional Communication: Keys To Purifying Complex Molecules

This summary features key takeaways from the Bioprocess Online Live event, "Challenges And Considerations For Purifying Multispecific Molecules."

How Modular Facility Design Can Accelerate GMP Facility Construction

Autolus Therapeutics' COO talks about the accelerated construction of the company's cell therapy manufacturing facility, The Nucleus.

A Facilities Expert Answers Audience Questions On Construction And Validation

Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.

GUEST COLUMNISTS

Unlocking Value In Biopharma Operations: A C-Suite Call To Action
Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.
Audit Trail Compliance And What To Look For In Mitigation Software
In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.
The New Clinical Packaging Paradigm: Differentiation And Decentralization
The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?
Drug Facility Design For Live Biotherapeutic Products
Live biotherapeutic products use live microorganisms or yeast as active agents to prevent or treat diseases. For pharma manufacturers entering this emerging field, understanding the unique GMP requirements is critical.
What Did ICH Q14 Miss On Analytical Method Validation?
Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.
June 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

BIOPROCESSING WHITE PAPERS

The Problem With Construction Quality
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

Tackling The Cost Of Poor Quality: Strategies And Solutions
2/5/2025

Don’t let the cost of poor quality hold your business back. Discover how a modern QMS can transform your operations and drive success.
Oligonucleotide Synthesis: Scale-Up Made Simple
10/16/2024

Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.
Optimizing Poloxamer 188
1/13/2025

Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.
The Role Of Change Management In Supporting Innovation In Pharma
10/29/2023

Learn in detail about the impact of change management on the pharmaceutical industry and how it ensures innovations and improvements are managed effectively.
Vial Fogging: Practical Considerations For Vial Selection
10/16/2024

Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.