Newsletter | October 8, 2019

10.08.19 -- Introduction To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

Featured Editorial
An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
By Michael Song, Ph.D., AstraZeneca

This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
By Jerry Chapman

This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

Industry Insights
4 Steps Toward End-To-End Connected Manufacturing
Article | By Avril Vermunt, GE Healthcare Life Sciences

Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

Embrace Quality Risk Management To Build A Strong Quality Culture
Article | By Cheryl Abernathy and Bryan Sasbon, Ropack Pharma Solutions

Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

What Water Treatment Advancements Mean For Pharma
Article | By Mike Henley, Ultrapure Water Journal and Industrial Water Treatment

Pharmaceutical water is key to the production of pharmaceutical drug products, and there have been a number of technological advancements in high-purity pharmaceutical-grade water.

Manufacturing Of Sterile Aqueous Suspensions: A Primer
White Paper | By Omar A. Salman, Ph.D., Pfizer CentreOne Contract Manufacturing

Sterile suspensions are particularly difficult to manufacture. This white paper covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.

Improve Safety In Your Mixing Room
Application Note | By Christine Banaszek, Charles Ross and Son Company

In the processing world, safety management cannot be overemphasized. The mixing room, in particular, is a source of many potential health and operational hazards.

The Right Biomanufacturing Partner Can Mitigate Forecasting Risks
Article | Thermo Fisher Scientific

While forecasts can never be 100-percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.

Detecting Residues In Cleaning Validation
Article | Alconox, Inc.

When beginning cleaning validation a company must identify the residues to be tested and then select the best detection method.

Ensuring IPC And QC Of Final Products In Pharmaceutical Production
Application Note | Anton Paar USA

Density measurement is a powerful and important method to ensure in-process control (IPC) and quality control of final products in pharmaceutical production facilities.

Single-Use Fermentor Process Optimization And Scale-Up Of Microbial Cultures
Poster | Thermo Fisher Scientific

Innovations in single-use technologies have allowed traditional microbial fermentation processes to capture the benefits proven over the past decade using disposable processing equipment.

Top Five Oral Dosage Forms By Portfolio Composition
Infographic | ISR Reports

The top five oral dosage forms account for more than half of products in oral dose portfolios and are: tablets, capsules, controlled release tablets, controlled release capsules, and immediate release tablets.

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