Issue link: https://www.e-digitaleditions.com/i/1052795
46 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m "It is still a little bit of a challenge where there are different techniques optimal at different concentra- tion ranges and you have to understand there could potentially be concentration effects that go along with that," says Yoder. "So, often times you are expected or forced to use orthogonal methods to validate certain data outputs." "In development, you really don't have a lot of material; it is in short supply, and it is very diffi- cult to get enough sample to do the analysis," says Fleming. "It is really good to have a technique that is very sensitive, needs a very small amount of ma- terial, and that doesn't require manual labor to do the testing." "Techniques that allow you to study your product in its native conditions like DLS, AUC, or MMS are particularly useful in drug development," says Shah. Fleming notes that the MMS technology can analyze secondary structure by IR using 0.1 mg/mL concen- tration, providing "decent quality spectra." Yoder notes the importance of automation in light of pressures to accelerate development timelines. He cautions, however, that automation can generate more data. "Collecting that and being able to easily sort through the data and make, hopefully, unam- biguous assessments of that data quickly is going to be important. The sheer amount of data generated now to support filings is, and will continue, to in- crease over time." New technologies for new timelines Training will play a more pivotal role as more so- phisticated techniques generate more data that will require analysis and interpretation, especially for mul- tiple samples across multiple platforms and multiple products, says Yoder. "I think we are going to see an increasing interest in machine learning and artificial intelligence to look at why the product was successful or why was it a failure from a biophysical or stability standpoint or efficacy standpoint," says Yoder. "I think tools will go beyond saying: 'I can generate a spectra and print that out and interpret it.' I think it will be increasingly important to understand a couple dozen options: What physi- cal form of the mAb or what presentation of a mAb or biologic is going to be the most efficacious or the most chemically stable? Those are difficult questions to answer anyway without generating data, but then understanding why that data [are] the way [they are], is very important in moving forward in development." Some analytical advances result from new applica- tions for existing technologies that are streamlined for biological material studies and productivity. "Most new platforms are based on automation with the aim of making workflows simpler, more consis- tent, and designed for higher throughput of samples," Shah says. Kendrick notes the importance of under- standing different tools and figuring out how applying them to techniques that are completely unrelated— like spectroscopy and particulate analysis—can help everybody continue to improve those tools and get ideas across different platforms. PT Protein Characterization Alcami ................................................................................................ 21 LabVantage Solutions, Inc ....................................................................3 Lonza ................................................................................................. 17 Patheon Pharmaceutical Services Inc .......................................... 30–31 Tomi/Steramist ..................................................................................25 Veltek Associates................................................................................ 11 Ad Index COMPANY PAGE