ADMA Biologics, Inc.’s Post

The comparability strategy for a post-approval production cell line change of a bevacizumab biosimilar (IBI305 from Innovent) is presented. Cell line changes are considered to have a relatively high potential risk to product safety and efficacy. Demonstrating the comparability for post-approval production cell line change poses a big challenge. Therefore, such changes are often done before pivotal studies during clinical trials. Altruist Biologics' recent case study demonstrates a three-way analytical and non-clinical comparability study strategy. Learn more about the successful outcome of this post-approval cell line change and its alignment with Altruist’s CDMO mission today. https://hubs.ly/Q02s0s410

Today, CASSS – Sharing Science Solutions and #FDA will kick off day 1 of their WCBP symposium, and address the role of current and emerging #CMC analytical technology among evolving US and international #regulatory perspectives. Hear from and engage with thought leaders 💡 on a wide range of topics including CMC development strategies, innovative analytical characterization, global submission strategies, next-generation therapeutics & vaccines, as well as the challenges and promises of #CRISPR-based therapeutics, which are poised to revolutionize the #futureofmedicine.

#WhySwitzerland for biotech & pharma? 💡 Anne Marie de Jonge-Schuermans, Board Member of the 🇨🇭 Swiss Biotech Association and Global Head of Biologics & Injectables Operations at Sandoz, discusses the Swiss biopharma ecosystem and the business and career opportunities with Medicine Maker. 🚀 Read about it in this article: https://loom.ly/D6U5z3k The Medicine Maker, Swiss Biotech Association, Sandoz

It's never to soon to think strategically (but there are lots of reasons that often get in the way). In this article me and my fellow authors explore why early strategic thinking can give you a headstart in the drug development process and help you to avoid some of the potential roadblocks on your journey to patients. We also take a look at why this is even more important in emerging areas like cell and gene therapies where pathways are less established and the landscape is constantly changing

For those involved in strategic planning for novel therapeutics, this excellent whitepaper is worth a read.

Thoughts on this? >> Sionna licenses clinical-stage cystic fibrosis assets from AbbVie shortly after large Series C >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #biotech #pharmaceutical #productmarketing

Thoughts on this? >> Nuvalent's $350M offering; FDA lifts partial hold on Zentalis drug >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #healthcare #biotech #productmarketing

A fantastic article on the importance of early strategic planning for novel therapeutics authored by my wonderful colleagues in Evida and Seques with Manca Povsic from the AMICULUM Access team adding her insights from a market access perspective. Download the white paper to learn more and get in touch with myself or the team if you'd like to discuss your needs in this area. #marketaccess #earlystrategy #pharma #atmp