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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.

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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

Understanding FDA's New National Priority Voucher Pilot Program
The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.
The Latest Techniques And Technology For Differentiating Capsids
Since AAV gene therapy’s origins, scientists and regulators have sought optimized ways to measure empty/full capsids. This expert reviews pros and cons of modern methods.
AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management.
Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
Ask The Pros — The Latest In Downstream HCP Mitigation
Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.
How Is RIM Software Transforming Regulatory Compliance?
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
Draft EMA Doc Proposes More Flexibility On Biosimilar CES Requirements
Clinical efficacy studies may not be necessary under certain conditions, writes the European Medicines Agency in a new draft reflection paper.
Exploring The Market For Closed-Loop Cell Therapy Production
The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.

BIOPROCESSING WHITE PAPERS

Tackling The Cost Of Poor Quality: Strategies And Solutions
Don’t let the cost of poor quality hold your business back. Discover how a modern QMS can transform your operations and drive success.

Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing
4/24/2024

Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
The Evolution Of Antibody-Drug Manufacturing
6/3/2024

Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
Vial Breakage During Lyophilization: Root Causes And Mitigation
10/16/2024

Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
Utilizing MAPPs For An Enhanced Assessment Of Immunogenicity
1/4/2024

Explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.
Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
3/24/2025

Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency, reliability, and innovation in bioprocessing workflows.

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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.