Newsletter | December 1, 2020

12.01.20 -- Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics

 
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Industry Insights
The Physical Properties Of An API And Drug Product Performance

An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

Is Your API Ready For Scale-Up? What To Demand From Your CDMO

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Managing The Challenges Of Small Batch Formulations

A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.

4 Reasons Blow/Fill/Seal Technology Should Be Considered For Aseptic Filling

Drug manufacturers seeking alternative methods for a safe and reliable approach to drug delivery should consider blow/fill/seal technology, as it offers several benefits over traditional glass packaging.

Evaluating The Container Closure Integrity Of A Vial Using Headspace Gas Ingress Methods

Proper packaging prevents ingress of contaminants. Unfortunately, these contaminants are not always visible to the human eye, and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.

Superior Biopharmaceutical Manufacturing Facilities Prioritize Cleaning And Disinfection During Design

Thorough consideration of cleaning and disinfection during facility design eases maintenance across the facility life cycle, optimizes workspace utility, and contributes to efficient facility operation.

Standardizing Biosample Management: Why Use Collection Kits?

Whether conducting a Phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples. These basics of sample collection planning will help make the process cost-effective.

Making The Medicine Go Down: Specialized Oral Solids Delivery Technologies

Most oral solid formulations are designed to release the drug immediately after swallowing for rapid absorption into the bloodstream. However, some products have been developed to release the drug in a specific way following ingestion and provide a “controlled release” of the drug products.This article discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.

Enabling Fast And Appropriate Drug Product Supply For Phase 1 Clinical Trials

Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs. Without the ability to move smoothly from lab concept to the manufacture and delivery of GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.

Determining Performance Improvements In NovaPure Plungers For Syringes In Autoinjector Systems

NovaPure 1 to 3 mL plungers were developed for use in prefilled syringes — especially those coupled with autoinjectors. This poster presents a one-year study examining performance with placebos of different viscosities (1, 8, 15 cps) in a laboratory configuration that replicates an autoinjector.

Automation Of Class III Medical Device Packaging

This article will explore the need for sensitive and fast automated container closure integrity (CCI) testing technologies that are also reliable and how existing solutions can help achieve optimum quality goals for medical device manufacturers.

Are You Prepared For The Complexity Of Pediatric Drug Development?

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

Robust Process Development For cGMP Manufacturing Of Cell Therapies

By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. 

Breaking The Misconceptions Of Maximum Compression Force

With proper formulation development and tablet design, the tablet press operator should be able to manufacture quality tablets without exceeding the tooling’s maximum compression force rating.

Using In-Line Sensors For Real-Time Control

Within biopharmaceutical production there is a shift from manually monitoring processes to real-time control and automated intervention. The goal is to develop algorithms and AI solutions that are able predict outcomes and create autonomous systems. This paper exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.

The API Process Development System For Personnel And Product Protection

The API Process Development System was designed to provide personnel and product protection when working with powder and liquid substances. Read more about this solution that offers easy operator access for cleaning purposes, inlet HEPA filtration, bag-in/bag-out filtration with dual HEPA filters, and LED lighting and acrylic viewing panels tp maximize lighting across the workspace.

The Rise In Single-Use Containment For Contract Manufacturing Organizations

The on-demand webinar CMO/CDMO Facilities Gain Value with Single-Use Containment presents a case study for an oral solid dose (OSD) process, shared facilities, and HBEL/ADE requirements.

Accelerating Optimal Cell Culture Media Design: Using A Diverse Panel To Reduce Uncertainty

Selecting the optimal media for a specific cell line’s growth can be a challenging task, partly due to the quantity of catalog and custom options available. This on-demand webinar reviews best practices using a media panel approach to reduce timelines and increase productivity.  

Solutions
Events

Webinar
December 8, 2020 | 10:00 a.m. EST

This webinar will cover how reformulation strategies are being utilized to modify the drug release profile of original products. One key area of focus will be highlighting how functional excipients can be used to reformulate existing products into superior dosage forms such as sustained release multiparticulates and matrix tablets.

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