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Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

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EDITOR'S DESK

We're A Virtual Biotech. CDMOs Should Treat Us As A Priority
Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.

FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

Supporting The Next Generation Of ADCs

Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

The 9 Fastest-Growing Outsourcing Segments

Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

GUEST COLUMNISTS

Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
The Hidden Engineering Behind Successful Upstream Bioprocessing
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

BIOPROCESSING WHITE PAPERS

Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein
Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.

Leveraging Life Sciences Data For Intelligent Decision-Making
2/18/2025

Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.
Providing Enhanced Manufacturing Data To Contracting Companies
2/12/2025

The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.
Leveraging Digitalization To Resolve CGT Manufacturing Challenges
2/12/2025

Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.
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.
Overcoming Challenges To High-Concentration Formulation Development
3/25/2025

Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective 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.