Pharmaceutical Technology ePT Weekly
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PharmTech
October 3, 2019
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In this issue:

Janssen Uses Insilico’s Digital Twins for Cell Culture

NIH Awards The University of Georgia Up to $130 Million for Flu Vaccine

JM Canty International and NIBRT Team Up for Optical System Research Collaboration


Top Stories

AstraZeneca Announces Sale of Acid Reduction Drug for $243 Million

The $243 million will be paid upon completion of the agreements along with sales-contingent milestones of up to $33 million in 2021 and 2022.
/ read more /


GSK Invests $120 million in
US Biopharmaceutical Manufacturing Facility

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.
/ read more /

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Industry News

NIH Awards The University of Georgia Up to $130 Million for Flu Vaccine

The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.
/ read more /


BIA to Hold Events Aimed at Preparing Life
Sciences Businesses for Brexit

BIA will be hosting a series of events and webinars to support small-and-medium sized enterprises in life sciences in the preparations for a possible ‘no-deal’ Brexit.
/ read more /


More Industry News
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Supplier News

TrakCel Forms Cell and Gene Therapy Supply Partnership with WuXi AppTec

The partnership combines global CDMO services with a cellular orchestration platform
/ read more /


JM Canty International and NIBRT Team Up for Optical System Research Collaboration

The companies plan to collaborate for the advancement of an optical system for on-line analysis of mammalian cells during a bioprocess.
/ read more /


More Supplier News
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High-throughput toxicity screening can be problematic:
ATCC has a solution. Explore this study demonstrating OAT1, OCT2, and OAT3-expressing immortalized primary renal cells provide physiologically relevant data for preclinical toxicological studies.
/ Register Now /


Bio/Pharma News

Janssen Uses Insilico’s Digital Twins for Cell Culture

Janssen will use Inisilico’s digital models of cells to accelerate cell-line development for biologics manufacturing.
/ read more /


Problems With Ranitidine May Transcend
Manufacturing Issues

The root cause of NDMA contamination may go well beyond manufacturing problems, to the molecule itself.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Issues Complete Response Letter for AstraZeneca COPD Drug Application

AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.
/ read more /


FDA Gains Approval to Revamp New Drug
Review Operations

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.
/ read more /


More Regulatory News

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FEATURED TOPICS

PEER-REVIEWED RESEARCH

Degradation Pathways: A Case Study with Pegylated L-Asparaginase

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
/ read more /

SCALE UP

A Systematic Approach to Tech Transfer and Scale-Up

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.
/ read more /

DRUG DEVELOPMENT

Avoiding Excipient Variability

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.
/ read more /

FACILITY DESIGN AND ENGINEERING

Best Practices for Vacuum Conveying of Pharmaceutical Powders

When specifying an automated powder transfer system for vacuum conveying of pharmaceutical powders, consider material properties, facility constraints, and designs to mitigate explosion.
/ read more /


UPCOMING WEBCASTS

Data Integrity and the Next Level of Connectivity in a Modern Lab
Tuesday, October 29, 2019 at 11am EDT | 8am PDT| 3pm GMT| 4pm CET
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A Roadmap for Early Development to Commercial Manufacturing
Thursday, October 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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An Integrated Approach to Rapidly Delivering Bioavailability-Challenged Small Molecules to the Clinic
Wednesday, October 23, 2019 at 11am EDT| 8am PDT|4pm BST|5pm CEST
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New Draft USP <922> Chapter for Water Activity Measurement
Tuesday, October 22, 2019 at 11am EDT| 8am PDT| 4pm BST | 5pm CEST
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Workflow Breakthroughs that Are Improving Data Quality and Efficiency and Changing Pharmaceutical Analysis
Europe: Wednesday, October 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
US: Wednesday, October 16, 2019 at 2pm EDT | 1pm CDT| 11am PDT
Register Now



ON DEMAND WEBCASTS

APIs and ADCs: A Journey Through High Potency
On Demand
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Excipient engineering and design to enable continuous manufacturing
On Demand
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How Can You Transform the Patient Experience through Digital Transformation?
On Demand
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The Evolution of Cellulose in Tableting Technology
On Demand
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The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success
On Demand
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Protecting Oxygen-Sensitive Formulations Throughout the Product Lifecycle
On Demand
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From Basics to Best Practices: Exploring Bioassays and Binding Assays
On Demand
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Identifying and Solving Scale-up Challenges in the Synthesis and Formulation of Small-Molecule APIs
On Demand
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Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery”
On Demand
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Events

Wearable Injectors and Connected Devices Conference 2019

October 9–10, 2019

IVT's 25th Annual Validation Week

October 16, 2019

Rare Diseases & Orphan Products Breakthrough Summit

October 21–22, 2019

more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.


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