Bioprocess Online for bioanalytics, biopurification, bioproduction

FDA Leading The Decline Of Animal Testing

The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).

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EDITOR'S DESK

Finding Compatibility In Love And CDMO Partnerships
Just like people, some sponsor-CDMO partnerships can be matches made in heaven. Others, not so much. See what experts have to say about finding the right CDMO and building a successful partnership together.

Five Takeaways from BIO 2025 and Why You Should Stay Tuned

New chief editor of Drug Discovery Online shares insights from BIO 2025’s global biotech gathering and spotlights the impacts to early-stage drug research.

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."

GUEST COLUMNISTS

4 Centralized Comparator Sourcing Models To Fortify Supply Chains
A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.
Essential Steps For A Successful Analytical Tech Transfer
Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.
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.
Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights
Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.
Managing Extractables And Leachables In HPAPI Manufacturing
These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.
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?

BIOPROCESSING WHITE PAPERS

Enhancing Safety And Efficacy Of mRNA-Based Therapeutics
Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.

Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing
5/7/2024

For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.
Supplier Quality Is Only As Strong As Your Weakest Link
2/5/2025

Your supply chain is only as strong as its weakest link. 52% of organizations attribute recalls to supplier-related issues, and proactive supplier quality management is essential to protect your brand.
Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
2/20/2025

Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
Next-Generation CRISPR Approaches
7/16/2024

By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.
A Guide To Accelerating Cell Line Development For Commercial Production
7/11/2025

Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.

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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.