Newsletter | September 10, 2020

09.10.20 -- Repurposing An Aging Facility To Produce Cell And Gene Therapies: Layout And Design Considerations

 
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Managing Risks With Potent Pharmaceutical Products

Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

How Extrusion-Spheronization Can Help To Control Delivery And Enhance Performance Of Complex Therapies

In this blog, we explore why and how the technique of extrusion-spheronization offers pharmaceutical companies a robust, proven way to manufacture today’s most complex therapies. We also discuss the key considerations for drug developers who are looking to select a contract manufacturer as a partner to deliver this technique.

Common Challenges And Solutions Of Equipment Ownership And Use

There are many factors to consider when tasked with acquiring the equipment needed to run a pharmaceutical facility. Being aware of all up-front costs is a must when determining optimal equipment ownership. See how state-of-the-art used equipment can be a great strategy to achieve cost savings for businesses.

Freeze-Drying COVID-19 Diagnostics: Formulation And Process Development And Lyophilizer Selection

Lyophilization may be considered a relatively gentle drying process, but there are still risks and pitfalls when applying it to biomolecular reagents in diagnostic tests that are different to the freeze-drying of general pharmaceuticals. This article summarizes a recent webinar exploring various aspects of formulation and cycle development in the lyophilization of diagnostic reagents, including those required for COVID-19 testing, that may be different to regular diagnostics.

Containment Solutions For Safe Handling Of HPAPI Chemical Synthesis

With high potency active pharmaceutical ingredients (HPAPIs) comes a heightened awareness of safe handling requirements and the added burden of a higher level of regulatory oversight.

Improve Facility Monitoring Systems To Comply With Regulations

A facility monitoring system is a process monitoring tool that collects data from sensors, such as optical particle counters, differential pressure sensors, and temperature probes, in real time.

Purposeful Design, Development Of Next-Gen Single-Use Bioprocess Film

Cytiva's investment in Fortem film development will help meet the industry need for a fully characterized platform film for bioprocessing applications, with supply chain transparency as a focal point.

Science Of Scale For Spray-Dried Intermediates

Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which can lead to poor bioavailability. This application note identifies some critical steps that can smooth the development pathway, eliminating scale-up headaches down the road.

Study: One Novel Purification Tool And Its Effects On Host Cell Protein Reduction And Turbidity In Low Isoelectric Point Target Proteins

The 3M Emphaze AEX Hybrid Purifier is a novel purification tool that utilizes a Q-functional hydrogel and 0.2 μm membrane to reduce impurities in a biopharmaceutical downstream process. This study involved a design of experiment (DoE) approach to investigate the effects of pH and conductivity on the turbidity, yield, and impurity clearance of the Emphaze AEX Hybrid Purifier and the efficiency of the subsequent protein capture step.

A Rapid Alternative To Culture-Based Mycoplasma Detection

Mycoplasma contamination represents a serious, costly problem for biomedical research labs and facilities involved in development and manufacture of cell-derived biological and pharmaceutical products.

Keeping It Cool: Protecting Cryopreserved Biological Samples From Degradation

Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze-thaw.

Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing

Blow-fill-seal (BFS) technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

TPE Tubing Weld Testing

This tech bulletin demonstrates the aseptic weldability and sealability of thermoplastic elastomer (TPE) tubing for use in numerous applications requiring aseptic liquid transfer. 

Tech Transfer And Scale-Up For Custom APIs Driven By A Collaborative Culture

Technical expertise and access to state-of-the-art equipment and facilities are necessary, but insufficient, for the successful completion of small molecule API technology transfer projects. CDMOs must have a collaborative culture that encourages open and transparent communication among internal team members, client representatives, and other external partners.

Installation Of Powder Transfer System And Powder Blender To Achieve Sterility Level Requirements

A facility handled sterile blending and packing powder from a tilting filter dryer under sterile conditions. They were transferring the discharge of the tilting dryer by screw feeder and transferring into an agitated mixer, and then discharging the mixer by a screw feeder into a packing system. They were encountering sterility loss through mechanical seals and docking of the dryer to the screw feeder and difficulties to clean and sterilize the system in place. A solution was a full automatic system including a transfer system, batch mixer, and sampling device.

Capture OTC Market Share For Geriatric And Pediatric Patients

This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

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