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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.

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EDITOR'S DESK

Experts' Advice On Facility Design And Construction
This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs

According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will impact your U.S.-based CDMOs.

From BPI West: A Roundtable Discussion On Continuous Manufacturing

Process Development experts share their thoughts on continuous manufacturing at this year's BPI West, touching on its benefits and present barriers to adoption.

From BPI West: Key Challenges And Benefits Of Continuous Manufacturing

Continuous manufacturing was a hot topic of conversation at this year's BPI West. AstraZeneca's Ken Lee, Ph.D., weighs in during an exclusive interview with Bioprocess Online.

From BPI West: An Upstream Scientist's Advice On Target Glycosylation

Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.

GUEST COLUMNISTS

Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.
Amgen Bets On Agility In The Age Of AI
The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.
Peeling Back The Layers Of Radiolabeled Peptide Production
From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.
A Look At Elsa, The FDA's New AI Digital Assistant
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
Navigating Data Management Requirements For Sterile Manufacturing
Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.
Multispecific Trial Supply Stability Hinges On CDMO Agility
Naya's CEO describes the dynamics of producing a complex therapeutic for clinical trials on another continent, and how choice of CDMO plays heavily into that strategy.
The Promise And Challenges Of Cell-Free Protein Systems
CFPS use cell lysates or purified enzymes to synthesize proteins. They have emerged as a promising alternative to production with living cells.
Bracing For The Impact Of The Federal Workforce Reduction
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

BIOPROCESSING WHITE PAPERS

Trends In Precision Medicine: Cancer
Scientists are working to discover new and effective ways precision medicine can prevent, diagnose, and treat diseases such as cancer.

Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation
11/6/2024

Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.
What Pharma And Biopharma Should Know About Container Closure Integrity
8/1/2024

Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.
Revolutionizing Manufacturing For Pharma And Biopharma
7/9/2024

Explore the evolution of Industry 4.0 in pharmaceutical manufacturing, the benefits and implications of Smart Factories, and the challenges along the road toward implementing a Smart Factory.
Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks
9/11/2023

Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.
Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
8/14/2023

Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.

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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.