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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.

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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

Performance Of HEKima™ Adherent HEK Cell Medium
Explore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.

Comparing Single-Use To Fixed Bioprocessing Systems
9/1/2023

Several life cycle assessments have been conducted comparing the environmental impact of SUTs to conventional fixed systems, leading to results that could inform changes in bioprocess system use.
Bench To Bedside: Trends In Regenerative Medicine
7/19/2024

Discover the promising capabilities of regenerative medicine. Learn about four advanced techniques that can restore damaged tissue and offer hope to patients with severe conditions.
Is Sustainability The Key To Agile Biopharma Manufacturing?
3/18/2025

In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
Epigenetics Application Guide: RNA Modifications
9/26/2024

Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.
Trends In Precision Medicine: Cancer
10/24/2023

Scientists are working to discover new and effective ways precision medicine can prevent, diagnose, and treat diseases such as cancer.

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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.