Newsletter | September 20, 2022

09.20.22 -- Modular Design And Construction Of Biopharma Facilities

 
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How To Pick The Right CDMO For Late-Phase Clinical Trials

This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.

Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

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

Benefits Of Microparticle Technology For Oral Drug Solubility Enhancement

Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.

Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

Impact Of Freeze-Drying Process And Lyoprotectants On Nanoparticle Stability

Read highlights from a recent webinar describing the challenges of freeze drying nanoparticles and how a group has designed and evaluated solutions to lyophilizing LNPs.

Technology Selection To Enhance Bioavailability

Bioavailability challenges are among the toughest problems faced by today’s formulators. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

Supply Chain Security: Focus On Raw Material Variability

Qualifying two suppliers, increasing capacity, implementing a supplier scorecard, and surveying suppliers' number of production lines can help guarantee supply — but close attention must also be paid to raw materials.

10 Reasons Formulation Complexity Is On The Rise In Steriles

Complexity is rising in sterile injectables, driven by factors that include formulation and delivery. Reduce complexity and save time on the way to IND authorization and first-in-human trials.

Cultural Audits: What Are They And Why Are They Essential?

The medical device industry is familiar with quality audits, but it is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

Ensuring Product Quality And Safety Through Process Optimization And Characterization

Process replication at a small scale, verification runs, and satellite runs conducted in parallel to manufacturing are valuable risk mitigation tools that maximize efficiency and product quality.

How To Perform HPLC Method Transfer Between Analytical Testing Equipment

It is essential for analytical laboratories to successfully transfer analytical methods. We present a transfer of the HPLC method for related substances analysis of metoclopramide HCl.

Moisture Headspace Analysis For Efficient Scale-Up Of Freeze-Drying Capacity And Validation

With the application of nondestructive headspace moisture analysis, small-scale proof of concept studies can minimize project risk and the number of full-scale runs in the freeze-drying validation process.

Speed-To-Market: API Large Scale Commercial Manufacturing

A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large-scale assets, multinational sites, and exemplary quality systems/U.S. FDA track record.

Reducing Lead Time And Optimizing Costs

Explore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed-to-market.

Dosage Form Optimization For Patient-Centric Drug Development Process

In designing products with patients in mind by utilizing superior formulation and drug delivery technologies in the early phases of development, pharmaceutical companies can minimize risks on the path to market.

A Quick Guide To Dissolution Testing

What is dissolution testing, why is it critical, and what should you consider for your method validation? Learn more in this quick guide.

HPOS: Challenges And Considerations

Experts discuss key considerations and three primary challenges faced during the development and manufacture of highly potent oral solids.

How To Reduce Vibroacoustic Emissions For Your Turbopumps

In this webinar you will learn more about the advantages of the laser balancing technology for microscopy and mass spectrometry and how to achieve the optimal results for your application.

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