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November 03, 2020

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Tired of playing 21 Questions with Part 11/Annex 11?

Get all the answers from Vaisala Senior Regulatory Expert Paul Daniel in our video blog! Gain insight on out of spec sensors, incubator hot and cold spots and 21 CFR Part 11 Compliance. If that is not enough take a moment to add the corresponding webinar to your must watch list.

	Industry News

RevImmune Advances New COVID-19 Immunotherapy
RevImmune announced its "ILIAD-7" international randomized controlled Phase 2 trial in patients ... read more »

Sanofi Offers to Acquire Kiadis
Sanofi will make a public offer to acquire the entire share capital of Kiadis for EUR 5.45 per share... read more »

Agenus Doses First COVID-19 Patient with iNKT Cell Therapy
Agenus announced the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy... read more »

PerkinElmer to Acquire Horizon Discovery
PerkinElmer and Horizon Discovery Group have reached an agreement on the terms of a recommended all ... read more »

Boston Scientific Receives FDA Approval for the Ranger Drug-Coated Balloon
Boston Scientific has received FDA approval of the Ranger Drug-Coated Balloon, developed for the ... read more »

Aphena Pharma Completes $7M Expansion
Aphena Pharma Solutions has completed its $7 million facility expansion and renovation in Easton, ... read more »

	Featured Articles

Integration of PAT and Data Systems for Manufacturing Process Control and Quality Improvement: A Brief Review of Past Developments, Current Status, and Certain Future Considerations Since the publication of the FDA’s PAT Guidance in September 2004, significant progress has been made in many aspects which boosted innovation in ... read more »

Launch and Scale-Up of Multiproduct/Multiplatform Cell Therapy Manufacturing Facilities Cell therapies are living drug products that continue to provide hope and promise to patients around the world. They are transformative biological ... read more »

	Infographic

Top 5 Secrets to a Successful Cleaning Validation Program
Top 5 Secrets to a Successful Cleaning Validation Program
Here are five ways to ensure a successful and compliant cleaning validation program. read more »

	Featured Video

Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and ... watch »

On-Demand Webinar: Formulation and Development Strategies for Amorphous Solid Dispersion Drug Products
In this webinar you’ll learn formulation screening strategies for amorphous solid dispersions, details on an integrated approach for developing ASDs ... watch »

	Featured Products

PyroGene rFC Endpoint Fluorescent Assays
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i-Series Integrated HPLC Systems
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	Featured Whitepaper

The Process of Pharmaceutical Elastomer Selection for Injectable Biologics
Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating innovation in delivery devices and the rise of chronic diseases. According to ReportLinker’s report “Injectable Drug Delivery Devices Market - Growth, Trends, and Forecast”, the growing prevalence of conditions like cardiovascular diseases, obesity, and diabetes drove significant growth in the ... read more »

White Paper: Optimizing the Bio-Rad NGC Chromatography System for Cryo-EM Applications for High-Resolution and Low-Volume SEC
Structural biology is the three-dimensional study of complex biological molecules, like proteins, to determine their structures at atomic resolution. read more »

	Events

Injectable Drug Delivery 2021
Kensington, London – 05/12/2021
Innovations in formulation and device design for enhanced subcutaneous delivery SMi Group is pleased to announce the third annual Injectable Drug ... event details »

Oligonucleotide Therapeutics and Delivery Conference
London, UK – 09/22/2021
On the way to maximising the potential of oligo-based medicine Oligonucleotide therapeutics - the emerging medicine class - are harnessing the ... event details »

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