Newsletter | September 10, 2021

09.10.21 -- Prefilled Syringes: Best Practices In Container Closure Integrity

 
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Industry Insights
What You Need To Know About Equipment Qualification

Equipment qualification is a series of inspections, tests, and assessments to ensure that a given piece of equipment is compliant and ensures reliable performance. 

Meeting Oligo System Development Challenges Head On

Read how a customer-driven equipment developer leverages a longstanding trusted partnership with a supplier to redefine what is possible in oligonucleotide manufacturing.

Use Advanced Analytics To Usher In The Continuous Manufacturing Era

The need to analyze data more quickly with continuous manufacturing requires a robust data collection and integration strategy across your entire organization.

Particle Engineering For Inhalation Drug Delivery

This article discusses key parameters for choosing the right particle engineering approach to meet dry powder inhaler (DPI) target product profiles for inhalation-based drug products.

Container Closure Integrity Testing: Risks And Methods

An overview of integrity tests where a high sensitivity is required to prevent the risks of stability failure of highly moisture-sensitive drugs or the risk of biological ingress of sterile parenteral drugs.

The Value Of A BD Integrated System For Combination Products

This article looks at the advantages of using an integrated system for drug-device combination products, rather than sourcing components from different suppliers.

Tech Transfer Project Management Best Practices In The Era Of COVID

Since the onset of COVID-19, the industry has shifted into high gear to develop, test, and manufacture diagnostic tests, vaccines, and therapies. With these developments, the speed, challenges, and stakes involved in technology transfer have reached new heights. 

Small And Emerging Outsourced Manufacturing Activities

To better understand the outsourcing practices used by respondents’ companies, ISR asked research participants to provide an estimate for various manufacturing activities.

Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface

While everyone agrees on the universal use of the humble rubber glove, very little attention is paid to the type of material, surface topography, or pore size distribution of the glove itself. 

Application Of Maurice CE-SDS For Biopharmaceutical QC Workflows

In this application note, Maurice CE-SDS is evaluated on assay performance and method validation characteristics that are important for QC analytical testing using three reference molecules.

Clinical Trials And Business Continuity In The Age Of COVID-19

In this webinar we are joined by Rahul Chaturvedi, an expert in clinical development with 10+ years of experience, who discusses some of the ways clinical trials are being disrupted and how to shift your mindset to take advantage of this time to strengthen your clinical program.

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