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Current Trends in Regulatory Outsourcing Models

BIOLOGICS AND BIOSIMILARS MARKET

COMBINING SAFETY AND EFFICIENCY IN RECONSTITUTED DRUGS IN THE FAR EAST MARKETS

PRACTICE MAKES PERFECT

Novo Nordisk Pharmatech A/S

A New Strategy to Predict Neurovirulence Risk Associated with Covid-19 Vaccines

Predicting Quality Risks in Pharmaceutical Production

Applying PAT to the Continuous Digital Biomanufacturing of Monoclonal Antibodies

Chiral Chromatography in Pharmaceutical Analysis

CYBER-PHYSICAL SECURITY TOOL FOR CONTINUOUS PHARMACEUTICAL MANUFACTURING PROCESS

Get instant access to latest e-book

LATEST NEWSRead more...

24

Sep 2021

Amnio Technology Awarded U.S. Patent for Amniotic Allografts

Amnio Technology LLC a global leader in the development and distribution of amniotic tissue allografts is announcing today that the United States Patent and Trademark Office has issued a new patent titled Enriched Multilayer Amnion Derived Tissue Graft The new patent strengthens Amnio Technologys in...

24

Sep 2021

Phenomenex Announces the Release of New Biozen® SEC Size Exclusion Chromatography Columns

Phenomenex Inc a global leader in the research and manufacture of advanced technologies for the separation sciences announces the successful launch of NEW Biozen SEC Size Exclusion Chromatography Columns to the existing Biozen portfolio of biological workflow products for the analysis of monoclonal...

23

Sep 2021

Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster

Pfizer Inc and BioNTech SE announced that the US Food and Drug Administration FDA has authorized for emergency use a booster dose of the PfizerBioNTech COVID Vaccine for individuals years of age and older individuals through years of age at high risk of severe COVID and individuals through year...

23

Sep 2021

AbCellera and Everest Medicines Announce Multi-Target Collaboration to Advance New Antibody Therapies

AbCellera and Everest Medicines Limited announced that they have entered into a multiyear collaboration and license agreement to discover therapeutic antibodies for up to targets selected by Everest The partnership will help to expand Everests portfolio of novel medicines across multiple indication...

press releasesRead more...

24

Sep 2021

Everest Medicines Announces Approval of Investigational New Drug Application by China NMPA for SPR206

Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia announced today that the Center for Drug Evaluation CDE of the National Medical Products Administration NMPA o...

23

Sep 2021

AstraZeneca to discover and develop self-amplifying RNA therapeutics in new collaboration with VaxEquity

AstraZeneca has reached an agreement to collaborate with VaxEquity for the discovery development and commercialisastion of the proprietary selfamplifying RNA saRNA therapeutics platform developed at Imperial College London The strategic longterm research collaboration aims to optimise and validate V...

23

Sep 2021

Tonix Pharmaceuticals Expands Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Tonix Pharmaceuticals Holding Corp a clinicalstage biopharmaceutical company today announced it has expanded its research collaboration with Columbia University The research collaboration is focused on studying immune responses to COVID in healthy volunteers who have recovered from COVID or were asy...

23

Sep 2021

Quell Therapeutics Significantly Expands Clinical Manufacturing Capacity for its Engineered Treg Cell Therapies through a Collaboration with the Cell and Gene Therapy Catapult

Quell Therapeutics Ltd Quell the world leader in developing engineered Tregulatory Treg cell therapies for serious medical conditions driven by the immune system today announced it has entered a collaboration with the Cell and Gene Therapy Catapult CGT Catapult The collaboration will expand Quells c...

EventsRead more...

27 - 28

Sep 2021

2nd Euro Depression and Psychiatry Congress

PLENARENO
Barcelona

27 - 28

Sep 2021

25th European Biotechnology Congress

Dublin

27 - 28

Sep 2021

Healthcare Automation and Digitalization Congress

BGS Online Platform

29 - 30

Sep 2021

Clinical Pharmacy and Pharmaceutical Sciences

Nora Olivia
Rome

KNOWLEDGE BANK

Interviews

European Lead Factory

Head of European Screening Centre
Ton Rijnders is the Head of Screening at the European Lead Factory He holds a PhD in molecular biology and has an extensive experience with drug discovery in pharma with increasing managerial and scientific responsibilities Since November Ton is the General Director of Oncode Institute and has been involved since the very beginning in European Lead Factory via the partner Lygature

Articles

A Structured Review on BCRP-Mediated Multidrug Resistance

Many of the human ABC proteins are efflux transporters and three of them namely Pglycoprotein Pgp gene symbol ABCB the multidrug resistance protein MRP gene symbol ABCC and the breast cancer resistance protein BCRP gene symbol ABCG have been implicated to be the major efflux transporters responsible for multidrug resistance in cancer cells

Research Insights

The Promises Of Quantitative Systems Pharmacology Modelling For Drug Development

Abstract Recent growth in annual new therapeutic entity NTE approvals by the US Food and Drug Administration FDA suggests a positive trend in current research and development RD output Prior to this the cost of each NTE was considered to be rising exponentially with compound failure occurring mainly in clinical phases Quantitative Systems Pharma

Case Studies

Ambient Stable Biologics - Stable Aqueous Erythropoietin

Challenge Erythropoietin EPO is known to aggregate under heat stress which prevents storage of liquid compositions at ambient temperature The key challenge of this study was to demonstrate that the application of the ArestatT tools can reduce significantly aggregation of EPO at an elevated temperature compared with a marketed liquid formulation

Techno Trends

Daiichi Sankyo’s FLT3 Inhibitor Quizartinib Treats Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company Limited announced quizartinib an investigational FLT inhibitor for the treatment of adult patients with relapsedrefractory FLTITD Acute Myeloid Leukemia AML Quizartinib is the first FLT inhibitor to enhance overall survival as an oral single agent compared to chemotherapy in patients with relapsedrefractory AML with FLTITD an underlying drive...

White Papers

Increasing Tablet Production With Multi-tip Tooling: An I-holland Whitepaper

Summary Multitip punches increase the number of tablets produced per turret rotation which increases production rates of existing presses Steve Osborn product design manager at tablet tooling manufacturer I Holland spoke to Pharmaceutical Technology Europe about the key considerations for successful implementation of multitip tooling in tableting operatio

Advisory Board

Stella

Sanjoy Ray

Rustom

Phil

Neil J

Laurence

Kenneth I

Georg C

Frank A

Douglas

Christopher-

Alan S Louie

EDITORIAL SECTION

STRATEGY

Crucial Decision-making in Drug Development for COVID-19

Modelling and simulation has been growing rapidly in impact and is now actively used by biopharmaceutical companies worldwide for drug development and...

RESEARCH DEVELOPMENT

DIGITAL SOLUTIONS IN DRUG DEVELOPMENT

From mobile medical apps and fitness trackers to software that supports the clinical decisions that doctors make every day digital technology has been...

CLINICAL TRIALS

Double-blinding Capsules for Clinical Trials

Capsules are tried tested and trusted but that is not to say that the method is simple or without innovation Formulation considerations and patientcen...

MANUFACTURING

INTEGRATED CONTINUOUS BIOMANUFACTURING

Batch manufacturing is the technology platform that is currently used for production of biopharmaceutical products It involves stepbystep processing w...

Information Technology

ARTIFICIAL INTELLIGENCE IN PHARMACY PRACTICE

Artificial Intelligence AI and machine learningbased technologies have the potential to transform healthcare because they offer new and important insi...

EXPERT Talk

PHARMA LOGISTICS TRENDS

Pharma logistics is undergoing profound change throughout Asia as the ageing population drives a growing need for new pharma solutions together with s...

Current Trends in Regulatory Outsourcing Models

BIOLOGICS AND BIOSIMILARS MARKET

COMBINING SAFETY AND EFFICIENCY IN RECONSTITUTED DRUGS IN THE FAR EAST MARKETS

PRACTICE MAKES PERFECT

Novo Nordisk Pharmatech A/S

A New Strategy to Predict Neurovirulence Risk Associated with Covid-19 Vaccines

Predicting Quality Risks in Pharmaceutical Production

Applying PAT to the Continuous Digital Biomanufacturing of Monoclonal Antibodies

Chiral Chromatography in Pharmaceutical Analysis

CYBER-PHYSICAL SECURITY TOOL FOR CONTINUOUS PHARMACEUTICAL MANUFACTURING PROCESS

Get instant access to latest e-book

LATEST NEWSRead more...

24

Amnio Technology Awarded U.S. Patent for Amniotic Allografts

24

Phenomenex Announces the Release of New Biozen® SEC Size Exclusion Chromatography Columns

23

Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster

23

AbCellera and Everest Medicines Announce Multi-Target Collaboration to Advance New Antibody Therapies

press releasesRead more...

24

Everest Medicines Announces Approval of Investigational New Drug Application by China NMPA for SPR206

23

AstraZeneca to discover and develop self-amplifying RNA therapeutics in new collaboration with VaxEquity

23

Tonix Pharmaceuticals Expands Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

23

Quell Therapeutics Significantly Expands Clinical Manufacturing Capacity for its Engineered Treg Cell Therapies through a Collaboration with the Cell and Gene Therapy Catapult

EventsRead more...

27 - 28

2nd Euro Depression and Psychiatry Congress

27 - 28

25th European Biotechnology Congress

27 - 28

Healthcare Automation and Digitalization Congress

29 - 30

Clinical Pharmacy and Pharmaceutical Sciences

TOP ARTICLES

1

Approach for Producing Pharmaceuticals in Layer By Layer Fashion: Additive Manufacturing

2

Artificial Intelligence

3

Homeopathic Science

4

Nanoemulsion - A Promising Nanocarrier for Dermal Drug Delivery in Psoriasis

5

Pharma Regulatory Bottlenecks and Vaccination Delays

KNOWLEDGE BANK

European Lead Factory

A Structured Review on BCRP-Mediated Multidrug Resistance

The Promises Of Quantitative Systems Pharmacology Modelling For Drug Development

Ambient Stable Biologics - Stable Aqueous Erythropoietin

Daiichi Sankyo’s FLT3 Inhibitor Quizartinib Treats Relapsed/Refractory FLT3-ITD AML

Increasing Tablet Production With Multi-tip Tooling: An I-holland Whitepaper

Advisory Board

EDITORIAL SECTION

Crucial Decision-making in Drug Development for COVID-19

DIGITAL SOLUTIONS IN DRUG DEVELOPMENT

Double-blinding Capsules for Clinical Trials

INTEGRATED CONTINUOUS BIOMANUFACTURING

ARTIFICIAL INTELLIGENCE IN PHARMACY PRACTICE

PHARMA LOGISTICS TRENDS