Volume 7 Issue 1 - International Biopharmaceutical Industry

Current Edition

Volume 7 Issue 1

Biotech Sector Survey: From Investment Confidence to Strategic Collaborations

In the rapidly evolving landscape, ICON’s recently published biotech sector survey provides a roadmap through the intricacies of investment confidence, funding dynam...

16 April 2024 Volume 7 Issue 1 | Editorial Archives

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Volume 7 Issue 1

Extractables and Leachables for Inhaled Medicines

How risk assessments can improve E&L strategies Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) ar...

16 April 2024 Volume 7 Issue 1 | Editorial Archives

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Volume 7 Issue 1

A Guide to Understanding and Performing all Appropriate Validation Steps When Adopting a New Endotoxin Testing Reagent

Limitations of Common Endotoxin Testing Solutions The adaptation of in-house endotoxin testing for a pharmaceutical or medical device manufacturer can be a daunting ...

16 April 2024 Volume 7 Issue 1 | Application Notes

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Volume 7 Issue 1

Using Predictive Compliance Risk Analysis to Avoid FDA Penalties

In the complex landscape of global regulations, particularly within healthcare and pharmaceutical sectors, a robust compliance strategy is essential for maintaining ...

16 April 2024 Volume 7 Issue 1 | Editorial Archives

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Volume 7 Issue 1

Optimising Pharmaceutical Processes: A Guide to Lyophilisation Cycle Development

Lyophilisation, commonly known as freeze-drying, is a critical unit operation in the pharmaceutical industry used to preserve and stabilise both small and large-mole...

16 April 2024 Volume 7 Issue 1 | Application Notes

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Volume 7 Issue 1

Patients Are Waiting: Speeding Time to Treatment in Rare Disease

Companies are overcoming challenges to develop, launch, and educate on new rare disease medicines faster. Rare diseases are no longer rare. Every year, people’s l...

16 April 2024 Volume 7 Issue 1 | Editorial Archives

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Volume 7 Issue 1

Elevating Biomanufacturing Efficiencywith N-1 Perfusion Technology

In the dynamic world of biomanufacturing, the quest for improved efficiency and productivity continues to shape industry advancements. Among these innovations, the e...

16 April 2024 Volume 7 Issue 1 | Editorial Archives

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Volume 7 Issue 1

Considerations on the Development and Manufacturing of Generic Peptides

The development of generic versions of peptides such as Semaglutide, the drug substance inside Novo Nordisk’s blockbuster drugs like Ozempic®, Rybelsus® or Wegovy®, ...

16 April 2024 Volume 7 Issue 1 | Editorial Archives

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Volume 7 Issue 1

5,000L Single-use Bioreactors:The Next Generation in Biologics Manufacturing

The Thermo Fisher Scientific HyPerforma™ DynaDrive™ Single-Use Bioreactor line is suited for volumes ranging from 50L to 5,000L. Optimised for modern cell culture pr...

16 April 2024 Volume 7 Issue 1 | Application Notes

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Volume 7 Issue 1

Enhancing Process Flexibilitywith Automated Filling

During the production and filling of highly complex biopharmaceuticals in cell and gene therapy, precise flow measurement and accurate air bubble detection play a cr...

16 April 2024 Volume 7 Issue 1 | Application Notes

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International Biopharmaceutical Industry

IBI – International Biopharmaceutical Industry was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally.