Newsletter | November 7, 2019

11.07.19 -- Understanding The FDA's New KASA Framework


The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products, and medical interventions to the region. This e-book provides an illustration of cutting-edge presentations: from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production. Some of the articles you’ll find within the e-book are:

Download the full e-book here: BioProcessing Asia Conference In Review

Featured Editorial
Understanding The FDA’s New Knowledge-Aided Assessment And Structured Application (KASA) Framework
By Bikash Chatterjee, president and chief science officer, Pharmatech Associates

The FDA's new pharmaceutical quality assessment system is intended to capture and manage information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format with the intent to facilitate a concise and consistent quality assessment and largely replace freestyle text.

Increase In Drug Approvals, Priority Reviews Points To Bright Future For CMO Industry
By Adam Bradbury, industry analyst, PharmSource, part of GlobalData

New drug approvals are on the way up, as the FDA approved 11 percent more innovator therapies in 2018 compared to the previous year, spelling good news for both marketing authorization holders (MAHs) and CMOs. Data also shows that small and midcap pharma companies are increasingly turning to outsourcers to manufacture newly approved drugs.

Industry Insights
Cut It Out: The Role Of Gene Editing Technologies In Combating HIV
Article | By Bruce K. Brown, Ph.D., Thermo Fisher Scientific

Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells.

Complete Quality Control With Rotational Viscometry Applications
Article | By Neimar Da Silva, Anton Paar USA

To ensure a consistent flow of material during production, Anton Paar has designed the ViscoQC 300, a multipoint viscosity measurement tool for achieving outstanding results in viscosity determination.

Five Tips To Ensure Faster Equipment Procurement And Installation
Article | By Jim Coyne, Federal Equipment Company

Used equipment is readily available, cuts lead time for delivery and install, and allows faster product launch.

Defining Feeder Accuracy For Continuous Processing
Article | By Sharon Nowak, Coperion & Coperion K-Tron

This article defines the items necessary for accurate feeding and outlines the important role that accuracy can play in the end product and process quality of any continuous operation.

Container Closure Integrity Testing Utilizing Mass Extraction Technology
Article | By Hemi Sagi, Advanced Test Concepts (ATC) by Pfeiffer Vacuum

Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.

Advances In Single-Use Technologies For Cell Clarification
White Paper | By Hemanth Kaligotla, Sartorius Stedim Biotech

One of the major challenges in batch mammalian cell clarification is cost-effective improvement in filtration in the face of high cell densities. 

Approaching Tablet Formulation Step-By-Step To Avoid Risks
White Paper | By Jonathan Gaik, Natoli Engineering Company, Inc.

All formulators need a methodology that gives them reliable and useful information to identify problems before tablet manufacturing begins.

Advances In Temperature Calibration Procedures
White Paper | By Ehren Kiker, Endress+Hauser, Inc.

Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

Speed Up The Pace Of Chemical Research And Development
White Paper | Dassault Systemes Americas

Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations, and new products that boost the bottom line. But are these labs as efficient as they could be?

Metal Detection System Improves Efficiency And Product Safety
White Paper | Thermo Scientific Product Inspection

The AuditCheck metal detection verification performance system utilizes an automated test shuttle that moves through the metal detector’s field at user-specified points in time.

System And Production Hygiene Method Using Sodium Hydroxide
Application Note | GE Healthcare Life Sciences

The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed.

Custom-Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations
Case Study | AES Clean Technology, Inc.

A GMP manufacturing suite was developed from its inception by AES, which included a custom-designed and constructed clinical manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

What Factors Influence Outsourcing Model Changes
Infographic | ISR Reports

In Q22018, ISR asked 100 people who outsource manufacturing to describe a scenario that has led or would lead their organization to change outsourcing models. 

Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies
Webinar | Nitto Avecia Pharma Services

This presentation demonstrates that in vitro, cell-based assays are an indispensable tool to quantify the biological activities, and to support the potency tests, for biotherapeutics.

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