For a recent KNect365 webinar, Christopher Bravery from Advanced Biologicals discussed the challenges of comparability for the ‘more complex’ biological molecules. He went into a detailed examination of purification, characterisation and activation, and their position within the space of biological comparability. Here we summarise the in-depth discussion that offers guidance and advice for those looking to meet the requirements of comparability for their molecules.
LISTEN TO THE WEBINAR HERE
First, Bravery outlines the differences between small molecules and biologicals which makes the characterisation of them a greater challenge for pharmaceutical companies. For small molecules, it is possible to know the exact molecular structure. When a cell substrate is introduced, the ‘manufacturing process is less clear’ as the ‘windows of characterisation are fogged with variability.’ This makes comparability much more challenging for cell based products as you are unable to define the molecular structure as easily. The proteins and the cell itself all vary in their phenotype, and are often more heterogenous, which adds to the uncertainty in the measurements taken.
Bravery defines comparability for biologics as the ‘need for a change in the process’ when the development is incomplete, either at post-approval or late stage. At this point, you should have characterised the raw materials to ‘understand critical quality attributes to establish process parameters’. He uses a hypothetical case study for a CAR-T product to demonstrate where comparability can need to be used within a development system, highlighting the area of ‘activation.’ (see diagram top)
Continue reading “Comparability for advanced therapy medicinal products with Christopher Bravery”
KNect365 is pleased to introduce a special Digital Week program, comprised of a week-long series of free webinars with live Q&A – connecting cell and gene therapy leaders throughout the year from the comfort of your desk.
Cell Therapy Manufacturing & Gene Therapy Digital Week connects cell and gene therapy leaders to drive manufacturing and commercialisation through direct access to innovative discovery, product development, and regulatory know-how.
Register now to watch free educational sessions presented by leading industry experts, get answers to your toughest questions, network with colleagues and partners, and download useful resources.
Continue reading “Cell Therapy Manufacturing and Gene Therapy Digital Week”
A Complementary Webinar from KNect365 & Pall
About this webinar:
November 15th, 2016 – 2:00pm EST
Great performance is no accident! An understanding of virus retention and filter fouling mechanisms is the foundation of the development of Pegasus™ Prime virus filters. Building upon this technical foundation, novel design features were developed and implemented to provide a reliable, simple and economic virus filter solution that delivers robust, high virus retention across a wide range of monoclonal antibody solutions.
Register to learn:
- How virus retention and filter blocking mechanisms influence virus filter design
- How the novel media surface morphology incorporated into Pegasus Prime virus filters increases performance
- How Pegasus Prime virus filters deliver reliability, simplicity and economy to your virus filtration processes
An upcoming webinar with Thermo Fisher Scientific
About this event:
As the global development of bio-therapeutics continues to rise, the rigorous characterization of process impurities and protein contaminants is becoming ever more critical. We have developed a novel qPCR-based ultra-high performance assay platform that proves to be an excellent overall solution for process analytics, particularly in the routine testing and accurate quantitation of host cell proteins and residual protein A. It offers sensitivity levels far surpassing that of any other immunoassay, with up to 5 logs of dynamic range. It retains excellent dilutional linearity and recovery throughout the entire assay range, with single-digit %CV assay precision. The Applied Biosystems™ ProteinSEQTM system is a content-agnostic assay platform that enables easy customization to detect and quantitate any protein impurity in bioprocessing and bioproduction. This study demonstrates the high performance quantitation of host cell proteins using an industry-standard antibody from the leading HCP vendor, and the ultra-high sensitivity quantitation of residual Protein A. Fully supported by instrument hardware with automated sample processing and qPCR reaction and readings, the ProteinSEQ system provides the best comprehensive assay solution for bioprocess analytics. Continue reading “Host cell protein and residual Protein A quantitation using qPCR”
On Thursday 25th February 15:00 CET / 14:00 GMT Informa are hosting a free webinar on the Implementation of Continuous Downstream Processing with Finesse Solutions Inc.
Leading the webinar will be Xavier Le Saoût, Associate manager – Biotech Process Sciences Technology and Innovation, Biopharma | Global manufacturing and Supply Merck Serono SA, Switzerland.
Also speaking will be Barbara Paldus, CEO Finesse Solutions Inc.
The webinar will be going through:
- Identifying which downstream steps are feasible for the continuous downstream processing
- Practical strategies for the implementation of continuous chromatography in DSP
- Improving capacity whilst maintain purity
- How to release buffers for use in continuous DSP?
- Case study insights from Merck Serono on implementing continuous mode in Biotech manufacturing
To register for this free webinar, click the blue ‘register here’ button above or below.
Make sure to check back for our post webinar Q&A.