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Accelerating Technology Diffusion In Cell And Gene Therapy

Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.

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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FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.
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.

BIOPROCESSING WHITE PAPERS

Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
10/16/2024

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells
6/28/2024

Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
Ready To Demystify Organoids?
7/1/2025

Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
GMP Calibration Management
8/8/2025

Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
Advancing QC Efficiency With SEC-MALS System And Empower Software
7/31/2025

Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.

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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.