Newsletter | August 3, 2021

08.03.21 -- What To Expect From A Remote Inspection

 
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How Scale-Up Benefits A Clinical Program To Get Results

A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market.

Understanding Multinational Regulatory Filings: New Chemical Entity

Finding the right CDMO partner for development and commercial launch of a new chemical entity presents sponsors with a challenging scenario that is magnified when a multinational launch is planned.

What's The Benefit Of An Engineering Batch In The Pharma Industry?

Challenges will inevitably be encountered before or during manufacture. An engineering batch can help avoid many predictable and unpredictable issues, minimizing cost and time before commercial production.

6 Misconceptions About Automating Cell Therapy Manufacturing

To help you move into a digitized world, here are six common misconceptions that can potentially hinder your ability to successfully execute a manufacturing execution system (MES) for cell therapy.

Optimizing Gastric Resistance In Complex Oral Drug Products With Novel, Functional, Ready-To-Fill Capsules

Functional capsules can improve a targeted drug delivery strategy and allow the use of more sensitive active molecules. 

Nanoparticle Engineering: Revolutionizing Oral Drug Delivery

Nanoparticle engineering — the process of shrinking down the size of drug particles — has emerged as a promising solution to increased hydrophobicity and poorer water solubility challenges. 

Virus Filtration Assurance Through Automation

Learn how to achieve virus filtration assurance with a purpose-built automation software that integrates our filtration expertise into your manufacturing suite at every step of the process.

Embedding Your Drug Strategy Within A Solid Foundation For Success

This white paper looks at the set of trends influencing pharmaceutical development and manufacturing strategy today, and how these drivers are influencing new business models with outsourced partners. 

Measuring Cell Density In Single-Use Bioreactors With Single-Use Sensors

This application note summarizes the sensor’s function, integration into the S.U.B. bulk pharmaceutical chemical, and showcases functional cell culture data obtained both internally and with a primary customer.

Determination Of Moisture Permeation During Product Shelf Life

Non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal packaging.

A Q&A: Manufacturing Dry Powder Inhaled Formulations By Spray Drying

Dr. Kimberly Shepard, Ph.D., associate principal engineer in R&D, discusses how spray drying can be used to address the challenges associated with late-stage lung cancer treatments.

Integrated Systems For Sophisticated Drug Device Combination Products

Discover the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems and the crucial role that BD can play as a systems integrator.

Life Sciences Success Podcast With Matt Hicks

Federal Equipment's Matt Hicks was recently interviewed by Don Davis on the Life Science Success podcast. The two discussed Matt’s career and how Federal Equipment buys and sells pharma equipment.

Shortening The Timeline To First-In-Human Clinical Dosage Form For Oral/Injectable Delivery

Lengthy early development timelines are common across new and emerging biotech companies for a multitude of reasons. Strategies for rapid development of a simple, yet flexible, format is beneficial.

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