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November 12, 2020

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Advancing the detection of E&L by Pharma Manufacturers Whitepaper

In this document, we look at how coupling the headspace sampling technique with an HRAM GC-MS system delivers a powerful technique to quickly assess and quantify potentially dangerous, untargeted volatile extractables in pharma workflows.

	Industry News

Senhwa Announces IND Submissions for Silmitasertib for COVID-19
Senhwa Biosciences has submitted an IND application with the FDA to evaluate Silmitasertib for ... read more »

Israeli Ministry of Health Authorizes Trial Evaluating Allocetra in Sepsis Patients
Enlivex Therapeutics reported the Israeli Ministry of Health authorized the initiation of a proposed... read more »

FDA Approves Updated Label for Endari
Emmaus Life Sciences has announced revised prescribing information for Endari to better inform ... read more »

Pfizer Initiates Study of Vupanorsen
Pfizer has initiated a Phase 2b study of vupanorsen in statin-treated patients with elevated non-... read more »

ISPE Names Sanofi the 2020 Facility of the Year Awards Overall Winner
ISPE announced Sanofi as the 2020 Facility of the Year Awards Overall Winner. 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

New Product Filing Strategies: Questions to Ask Your CDMO
Important considerations to minimize the stress caused by the regulatory journey. read more »

	Featured Video

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

On-Demand Webinar: An Optimized Workflow for Single-Cell Transcriptomics and Repertoire Profiling of Purified Lymphocytes from Clinical Samples
This webinar compares various sample preparation techniques for previously cryopreserved clinical samples and offers guidance to obtain high-quality ... watch »

	Featured Products

PC-10 Pregelatinized Starch
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i-Raman High Resolution TE Cooled Raman Spectrometer
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	Featured Whitepaper

eBook: Lipid Technologies: Helping to Develop the Next Generation of Pharmaceuticals
The FDA recently issued guidance intended to curtail the use of medically important antibiotics in agricultural applications. read more »

Safe and Effective Aqueous Solutions for the Pharmaceutical Industry
The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation. Virtually any pharmaceutical manufacturing equipment — from tablet presses to stainless steel mixing tanks — can be cleaned to stringent critically clean criteria by aqueous cleaning. read more »

	Events

Digitalizing Cell and Gene Therapies Manufacturing – a Lonza Case Study
Online – 11/17/2020
As cell therapy organizations move to industrialize their manufacturing operations and scale up their capacity, digitalizing their process becomes a ... event details »

Pre-Filled Syringes and Injectable Drug Devices 2021
London, UK – 01/13/2021
Device design, regulatory and strategic pathways for parenteral drug delivery SMi is proud to present the 13th Annual Pre-Filled Syringes ... event details »

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