As we continue to push the bounds of innovation, science and engineering of more advanced therapeutics, the challenge of bioprocess impurities also intensifies. Once harvested from the bioreactor, the race is on to separate and purify the drug product. The lack of clear guidance and standardisation for biopharmaceutical impurities has led to the traditional approach of sectioned purification trains being overcomplicated and resource heavy processes. This usually results in the impurity being "handed-off" to the next section of downstream processing to deal with, creating these unnecessarily elaborate purification trains to deal with it.
3M School of Purification presents our next webinar on the "Challenges of Bioprocess Impurities" where we identify, characterise and process these impurities. Demonstrating the next generation in downstream processing, in context with the last webinar series, bringing the workhorse of purification, chromatography, upstream to the harvest step, we can remove these impurities early on, resulting in process simplification and intensification that increase our drug product quality, efficacy and safety ready for patient
In this seminar we will specifically cover:
• What are product- and process-related impurities
• What guidelines from regulatory bodies do we have for impurity characterisation and quantification
• Case studies around host cell DNA, host cell proteins and aggregates
3M School of Purification
The 3M School of Purification is a program designed by a team of 3M Technical Experts, with the purpose of educating the industry on a range of important biopharmaceutical separation and purification topics through a series of interactive and engaging webinars in 2022.
To learn more about 3M School of Purification and to view all previous webinars
On-Demand, visit the newly launched website www.3m.co.uk/schoolofpurification