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European Biopharmaceutical Review

Winter 2021

Managing the Challenges of Manufacturing ADCs

Nicolas Camper at Abzena

With nine FDA-approved ADCs, this emerging class of biopharmaceuticals is changing the landscape of oncology treatments, but bringing an ADC to market requires complex manufacturing expertise and coordination between small molecule and biologics teams
Biosimilars – Transforming Global Patient Access to Treatments

Gabriela Marton at Arriello

Biosimilars provide cost-effective alternatives to biological drugs and represent a growing opportunity. However, Europe lacks a harmonised regulatory approach
Making the Right Choices for Reliable HCP Monitoring by ELISA

Martin Föge and Stefan Sommerschuh at BioGenes

The clearance of biopharmaceutical drugs from host cell protein (HCP) impurities during manufacturing remains a constant challenge, necessitating the reliable monitoring of their removal from the final drug product. The ELISA is the broadly accepted gold standard for HCP monitoring. Important steps for customised HCP ELISA development will be discussed
How to Optimise Process Quality of Liquid Tube Systems

Fernando Rangel at SONOTEC

Optimisation of liquid tube systems can be achieved in single-use bioprocessing applications by means of ultrasonic technologies
The Antimicrobial Susceptibility Testing Conundrum

Dr Lauren Laing and Dr Giles Sanders at TTP

Antimicrobial susceptibility testing at the point of care could slow the spread of antimicrobial resistance, but only creative technology development and regulatory equivalence data will unlock this prize
Fortifying Against Future Pandemics
If Only... 2020 In Review: The Value of Unified Regulatory Information Management

David Gwyn at Amplexor

The pandemic highlighted much about life science companies’ operational limitations, particularly around the way they manage and make use of regulatory information. It’s worth reflecting on how pharmaceutical organisations coped with the disruption of the last year and how this might inform ongoing digital transformation plans
Mental Health is Vital to Our Economic Recovery

Pierluigi Antonelli at Angelini Pharma

The coronavirus pandemic has had a detrimental impact in many areas of day-to-day life. One of these is mental health, which has been overlooked for far too long and should not continue to be sidelined any longer
You, Me, and the Two Cs

Andrew Newland at ANGLE plc

We are all aware of the unprecedented impact of COVID-19 on individual health and wellbeing, global healthcare systems, and economies; but what impact has COVID-19 had on cancer diagnosis and care?
IDMP – The Year in Review and Looking Ahead to 2021

Remco Munnik at Iperion Life Sciences Consultancy

Standing at the beginning of a new year, it’s a perfect time to highlight European progress with IDMP developments during 2020, and look ahead to what to expect this year

Amplified Needs Accelerate Innovation During a Pandemic

Patrick Schneider at Merck

COVID-19 has given the life science industry the opportunity to evolve and meet global demand, but can these advancements, and the lessons learned, help us stay ahead of the next worldwide health crisis?

Autoimmune Diseases
The Role of Eosinophils and Their Impact on Patients

As our understanding of eosinophils progresses, they are increasingly recognised as key biomarkers across a range of diseases. EBR spoke to Dr Jonathan Steinfeld at GlaxoSmithKline about the importance of eosinophils and how they can impact patients with a number of different conditions

Targeting the Root Cause of Inflammatory Gastrointestinal Diseases

Daniel Vitt and Jessica Breu at Immunic

A promising new approach for restoring the intestinal barrier function could pave the way for more influential treatments to help those who suffer from diseases such as IBD, IBS, or coeliac disease

Understanding the Burden of Eczema Around the World

Matthew Shaulis at Pfizer

Patients suffering with atopic dermatitis, more commonly known as eczema, require therapies to ease the burden of what can be a painful and life-altering condition
Cell and Gene Therapy
The Role of ddPCR in Developing Safe and Effective AAV-Based Gene Therapies

Mark White at Bio-Rad

There are a number of bioprocessing hurdles AAV developers must overcome to insure the generation of a safe and effective product. Luckily, there are also a number of technological solutions that can help face these challenges
Safety Testing for C&G Therapy Products

Claudia Benati, Liesbeth Hameetman, Luca Benedan, Giulia Rovaris, Mary David, and Dr Jonathan Demick at Eurofins BioPharma Product Testing

Available technologies for rapid testing offer possibilities for quick delivery of the genetically modified product for diseases that have long been considered incurable
The Challenges of AAV-Based Gene Therapy

Dr Hüseyin Besir and Dr Dana Holzinger at PROGEN

A lack of suitable and widespread reference material in gene therapy is just one of the many obstacles facing laboratories around the world attempting to find treatments for genetic diseases
Technology vs COVID-19
How COVID-19 is the Catalyst for a Digital Revolution in Healthcare

Mellissa Flowerdew-Clarke at Dept

The ongoing global pandemic has brought into sharp focus many of the pharmaceutical industry’s pitfalls in the areas of technology and innovation. Luckily, the process to address these weaknesses has already begun
Masks, Gloves, and the Power of a Better Idea: A Brief History of PPE

Jon Weisberg

The ascendance of COVID-19 has recently brought the value of effective PPE into a worldwide spotlight, and examining the history of all the equipment we take for granted today might provide us with further clarity as to its necessity
AI Solutions During a Crisis

EBR sits down with the Novartis Foundation’s Dr Ann Aerts to discuss the role of AI in the current pandemic, and how it can be a catalyst for change in the future fight against global health crises

Fast-Tracking Digital Innovation During Critical Times

Lorenzo Vasini at Paragon DCX

The pharmaceutical sales rule book has been torn up in the last year. Void of the biggest sales channel, face-to-face meetings, sales teams are seeking new means to engage the healthcare industry

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News and Press Releases

Merck Expands Life Science Production Capacities in the United States

Expansions to significantly increase capacity by end of 2021 to meet unprecedented demand Combined expansion of Danvers, Massachusetts, and Jaffrey, New Hampshire, USA facilities to create nearly 700 new positions Business sector’s announced 2020 investments total more than € 350 million
More info >>

White Papers

The Importance of Critical Temperatures in the Freeze Drying of Pharmaceutical Products

Biopharma Group

Every formulation has a critical temperature, below which it should be cooled for complete solidification and maintained below during primary drying in order to prevent processing defects. To design a freeze drying cycle on a rational basis such information should be identified.
More info >>

Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

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