Cytiva

Though we didn’t know it in the 17th century when a dog was injected using goose quills, we know it now: Bacteria and other contaminants can make patients very ill. That’s why the final aseptic filling step is so critical for making injectable drugs. How can we get better at protecting drug quality and patient safety? This e-book takes you on a journey to answer that question and others. Each chapter gives you practical insights: Dive into the “human factor” and why it continues to confound us. Discover why we need to go far beyond monitoring to keep contaminants at bay. Learn why regulators encourage the use of modern barrier technologies, such as gloveless isolators. Explore why airflow studies and computational fluid dynamics are key tools for qualifying aseptic filling processes. Learn how real-time tools for environmental monitoring can save batches and protect patients. Finally, get strategies for navigating complex regulations and see how innovation is helping companies deliver new therapies quickly and safely.

In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific antibodies. Then, he shares his top tips for addressing challenges associated with mAb aggregates removal and separation of homo and heterodimers.

In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perform process development in silico? Do I need to be a math expert? Where is modeling applicable? Will I not set foot in the lab ever again?

In this video, Emma Lind, Product Manager for Chromatography Resins at Cytiva answers questions from BioPharm International about the challenges faced by process developers working with recombinant proteins.

Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength and opportunities for collaborative growth. By working together, biopharma leaders, academia, and policymakers can create lasting improvements. Join Ludovic Brellier, President of Biotechnology Integrated Solutions and Business Operations Leader at Cytiva, as he delves into this year’s Index findings. Specifically, he’ll highlight where the industry should turn their focus to ensure that patients are continuing to get the essential life-changing therapies they need.

Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength and opportunities for collaborative growth. By working together, biopharma leaders, academia, and policymakers can create lasting improvements. Join Ludovic Brellier, President of Biotechnology Integrated Solutions and Business Operations Leader at Cytiva, as he delves into this year’s Index findings. Specifically, he’ll highlight where the industry should turn their focus to ensure that patients are continuing to get the essential life-changing therapies they need.

Antibody therapeutics are the largest class of biotherapeutics. Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispecific antibodies, antibody fragments, and antibody drug conjugates in the development pipeline. Manufacturing platform approaches conveniently used for many traditional mAbs are being adopted or tweaked to fit the respective molecule. In this ebook, you will learn about considerations and tips for developing chromatography protocols for antibody variants.

This white paper summarizes information around chromatography resin variability, providing support for developing robust purification bioprocesses.

This white paper summarizes information around chromatography resin variability, providing support for developing robust purification bioprocesses.

Give a quick overview of the oligonucleotide market, what is happening. Cover the typical challenges with oligonucleotide synthesis in the process development phase and solutions for those. Key considerations when scaling up oligonucleotide synthesis

Innovation has brought about a diversification of therapeutics molecules. In this discovery interview we will explore what mechanistic modelling is and how you can use it to develop these diverse therapeutics and what challenges this brings to the future of your process development.

Cytiva experts answer your top questions about challenging host cell protein assays to improve risk mitigation.