Grab your coffee and join the conversation as a panel of industry experts discuss the growing need for mass spectrometry throughout all development stages of the biopharmaceutical industry. We will focus on current challenges in the industry, success stories, and ways the use of mass spectrometry in supporting analytical labs can positively impact biotherapeutic development. Our round table discussion will be separated into 2 sections:
Section 1: How do our experts see the shift in mass spectrometry use/adoption in the biopharmaceutical industry over the past 10 years?
Section 2: Technical and software advances helping to pave the way, including overcoming speed bumps like big data challenges.
Hear personal experiences of implementing mass spectrometry in later development stages
In my previous position, I was working hard to incorporate mass spectrometry into a biotherapeutic process development workflow in a commercialization group at a pharmaceutical company. I saw first-hand the pressures on the industry to develop biotherapeutics faster and with more control designed into the process. We needed answers and clarity as we worked to improve the product manufacturing process, but what options did we have other than running more orthogonal assays? Our mass spectrometry lab was tasked with providing those answers and clarity to the commercialization group -- the land of process engineers who hadn’t crossed paths with a mass spectrometer before. As a mass spectrometrist, I was giddy with excitement knowing the power of mass spectrometry and what it could bring to the group, but really inserting the mass spectrometry group into the workflow was more challenging than I expected. Convincing upstream and downstream engineers to submit samples for peptide monitoring to generate product quality baseline data was no small feat. There were meetings after meetings to influence them on the value of the data and how it could be used.
Re-thinking the future of process controls, data and infrastructure
The next step was discussing with upper management the power of data being produced and how it could propel our process development at a new speed. In parallel, there were our internal questions, like “How would we ensure reproducibility, accuracy, specificity?” And “Is the method robust enough to be transferred from lab to lab?” As soon as we succeeded in getting the team on board and we had momentum in producing a mass of baseline product quality data, everything came to a screeching halt. Our data vault was HUGE and hard drives filled up fast. How would we handle all this data going forward? The questions and hurdles were endless but finding solutions and pushing forward was time and energy well spent to meet our process improvement goals.
The addition of mass spectrometry can increase certainty of results, improve process understanding, and lead to greater productivity overall. Not only is the adoption of mass spectrometry increasing in later stages of development, but from my experiences, I will go so far as to say mass spectrometry is the answer for the biopharmaceutical industry to accelerate development and relieve some manufacturing pressure points. Sharing experiences and learning from others who have “been there, done that” can propel the biopharmaceutical industry forward. I can’t wait to hear this round table discussion on our panelists’ experiences overcoming hurdles like these, advancing the industry, and more!