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Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities

The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

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EDITOR'S DESK

Governor Josh Shapiro On Supporting Biomanufacturing In Pennsylvania
Bioprocess Online's coverage of Governor Josh Shapiro’s fireside chat with BIO CEO, John Crowley, at the 2025 BIO International Convention.

How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction

Industry leaders share their philosophy on reducing product failure, embracing AI, and building dynamic teams to stay ahead of the curve to bring curative CGT therapies to patients.

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?

GUEST COLUMNISTS

FDA Priority Voucher Program Submissions Window Opens On New Website
The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.
5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution
Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.
Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs
There are different staffing options for building an agile and scalable team that can quickly react to shifting needs, resources, and funding.
5 Best Practices For Improving AI Literacy In A GxP Environment
ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.
AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies
A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.
All Of Us Need To Be Rooting For The FDA
In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.
Here's What Limits AI's Outlook For Replacing Knowledge Workers
Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.
How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much
In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

BIOPROCESSING WHITE PAPERS

Improving Safety And Efficacy With Charged Variant Characterization
Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

Exploring Perfusion Technology For Virus Manufacturing Process Intensification
1/28/2025

Perfusion cell culture technology supports high cell densities and product yields for viral vaccine manufacturing, offering a reliable way to produce high-quality cells at a commercial scale.
Best Practices In Commissioning And Qualification
7/5/2024

An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
Considerations And Options For Prefilled Syringes
10/16/2024

Explore the benefits of prefilled syringes to enhance product convenience, reduce drug waste, and streamline your pharmaceutical manufacturing process.
Small Volume ATMP Cryo-Freezing Strategies
3/11/2025

Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.
Challenges, Methods, And Solutions For Obtaining Optimal Starting Material
6/3/2025

For innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.

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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.