Being the youngest and only girl in the family has meant that I’ve provided my dad with that little extra level of worry. My dad is a cautious soul; especially when it comes to his children and their safety (yes, still now at our tender ages of 41 & 33, for my brother and me). You can expect to hear my dad’s favourite phrase: better safe than sorry, in response to most things that involve any hint of a risk. I’d like to say that I’ve always been of a similar thinking but unfortunately for my poor dad, I’ve always been a risk taker, the first to take off exploring the unknown and pushing myself to the limit. In many areas of my life I believe in risking the fall to know how it feels to fly!
I’d have to agree that my dad’s favourite phrase does have a place in certain instances and there’s no more so than in the design and development of biotherapeutic drugs. Biotherapeutics are complex. Their structure and composition are critically important to both their efficacy and safety and as such regulatory agencies demand their thorough characterization. With the development of ever more complex biotherapeutics we are faced with unprecedented analytical challenges.
To help overcome these challenges Thermo Fisher Scientific is hosting events in key biohub locations globally to create opportunities to connect, collaborate and work together to shape the future of biopharma chacterization.
Attendance is free but spaces are limited, register to confirm yours today!
The biotechnological mode of manufacturing protein drugs inevitably introduces at least some degree of heterogeneity of the end-product, particularly at the level of post-translational modifications (PTM). To fully characterize a biotherpaeutic candidate numerous analytical approaches can, and sometimes must, be employed. The biopharma summit events will include exciting new data and case study content from both Thermo Fisher Scientific and leading industry experts and will cover a broad range of biotherapeutic characterization approaches. Sample topics include:
Advanced QA/QC characterization
Biotherapeutics’ complexity currently means a number of different analytical methodologies are required during QA/QC – what if we could use a multi-attribute method to obtain all the necessary information (and more) in a single, robust and reliable 30 minute method?
ADC characterization on a single platform
MS analysis at the protein and peptide levels is critical during development and production of biopharmaceuticals. A single HRAM platform now offers distinct operational modes optimized for the top three protein characterization workflows.
Taking aggregate analysis from research into the routine environment
SEC is the most common analytical technique for Aggregate analysis. Here we explore the many analytical considerations for optimized SEC-UV & SEC-MS aggregate analysis.
Analytical strategies for unravelling glycan complexity in biologics
Glycan analysis is an important step in characterizing biotherapeutics, but no single technique can provide all the necessary information. See how the complete glycan story can be unravelled and simplified using a range of BioIC workflow driven strategies.
Taking charge variant analysis from research into the routine environment
When transferring through the development pipeline, making sure that analyses are simple but robust with no chance for error is critical. Novel reagents and innovative instrumentation ensure charge variant analyses can be transferred with ease.
Advanced fragmentation techniques for BioPharma characterization
Full sequence coverage requires the identification of modifications and sequence variants. This case study demonstrates the use of advanced fragmentation analysis to generate high sequence coverage of trastuzumab in middle down & peptide mapping analysis.