Newsletter | March 19, 2024

03.19.24 -- How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing

FEATURED EDITORIAL

How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing

To address today's challenges and other headwinds, organizations and partners must re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation roadmap efforts.

INDUSTRY INSIGHTS

Expert Approaches To Containment Design And Facility Integration

Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

Learn how USP 1207, the reference standard for container closure integrity testing (CCIT), applies to the CCIT inspection method of intravenous (IV) bags.

Changing The Therapeutic Landscape For Knee Osteoarthritis Pain

Patients facing osteoarthritis often experience excessive stiffness, mobility limitations, difficulty sleeping, exhaustion, and bone-on-bone grating. Explore the challenges in current pain management options.

Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

Here, we present three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

Nasal Vaccine Development, Manufacturing, And Device Selection

When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

Better Therapeutic Outcomes From Better Drug Delivery

Innovative drug-eluting implants, inserts, and transdermal films delivering biologics and small molecules can meet the goals of patient-centric therapies, improved medicine, and better healthcare economics.

Analysis Paralysis: Navigating Early-Phase Analytical Validation

Qualification’s reduced set of testing requirements aims to demonstrate a method is suitable for its intended purpose, but it typically is not as robust as method validation.

Five Considerations For Aseptic Connectors Versus Tube Welders

There are strong opinions on both sides of the tube welding vs. using aseptic connectors debate. Learn more about the flexibility, costs, training, and materials aspects to make an educated decision.

The Importance Of Finding The Right Media For Your CHO Subtype

Learn about the origin of CHO cell lines and how testing different media can help optimize your upstream production process.

Transforming Analytics To Optimize Cell Line Development

For cell line development, much of a workflow’s success hinges on how much analytical data a team can get — and how quickly — to inform their process.

Getting The Most From Your Inline Buffer Formulation System

An automated, integrated, responsive inline buffer formulation system can help eliminate the need for intermediate storage, reduce facility footprint, and accelerate timelines.

The Colloidal Particle Adsorption (CPA) Model In IEX

Learn about an adsorption isotherm class that is based on a colloidal description of proteins and achieves increased accuracy at high column loading in IEX modeling.

Cleanroom Design And Installation

Modular cleanrooms are both intricately engineered, high-performance machines and durable, working facility structures. Learn how they are compatible with your manufacturing process now and in the future.

SOLUTIONS

Small Molecule APIs: From Pre-RSM To Final API

A Leading CDMO Ready To Meet Your Complex Oral Solid Dose Needs

Manipulator System For Robotic Pharmaceutical Filling And Inspection

Fill/Finish Solution - Maximize Drug Product Recovery

Double Cone Blender For Manufacturing

Reducing Errors With An Innovative HPLC System

Bringing Science to Society

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