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Pharmaceutical and Biotech Manufacturing Case Studies
Save time, improve processes, and protect brand integrity
Pharmaceuticals and biopharmaceuticals must meet the most stringent manufacturing and production standards to ensure patient safety. Exceptional quality control means verifying raw materials, cGMP compliance, and testing the integrity of packaged medicines. Read these case studies to learn more about our solutions for each step in the pharmaceutical manufacturing process to help improve practices and produce the highest quality products.
Cell Culture Optimization Through Respiratory Gas Monitoring
- Process understanding and optimization of mammalian cell cultures is reliant on online and offline measurements
- Two projects were initiated to evaluate the online process mass spectrometry
- One of the cell lines was a GS-CHO producing lgG4 monoclonal antibody (mAb)
- Precision of the Thermo Scientific Prima BT Bench Top Mass Spectrometer was 50x greater for both CO2 and O2, and drift between calibration was eliminated
- When monitoring 12 fermenters the price of the mass spectrometer was equivalent to the low performance sensors
- High precision and speed analysis
- Better process understanding
- RQ could be seen and corrective action taken
- Cost savings
- Expensive media and labor hours were not wasted on failed fermentation batches
- The inclusion of methanol and ethanol analysis was realized at no extra cost
- Process understanding and optimization of mammalian cell cultures is reliant on online and offline measurements
- Two projects were initiated to evaluate the online process mass spectrometry
- One of the cell lines was a GS-CHO producing lgG4 monoclonal antibody (mAb)
- Precision of the Thermo Scientific Prima BT Bench Top Mass Spectrometer was 50x greater for both CO2 and O2, and drift between calibration was eliminated
- When monitoring 12 fermenters the price of the mass spectrometer was equivalent to the low performance sensors
- High precision and speed analysis
- Better process understanding
- RQ could be seen and corrective action taken
- Cost savings
- Expensive media and labor hours were not wasted on failed fermentation batches
- The inclusion of methanol and ethanol analysis was realized at no extra cost
Rapid Biologic Drug Product Identification
- Per FDA/GMP compliance requirements, customers must ID both bulk drug substance and final product
- Current technologies like peptide mapping are difficult and time consuming
- Many customers must send samples to centralized labs
- Point of use solutions to replace existing testing workflows
- Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools enables customers to remove the overall burden from QC labs
- From 10 days to 10 minutes
- More cost effective
- Point-of-use testing without requiring sites to have expensive testing technologies
- Per FDA/GMP compliance requirements, customers must ID both bulk drug substance and final product
- Current technologies like peptide mapping are difficult and time consuming
- Many customers must send samples to centralized labs
- Point of use solutions to replace existing testing workflows
- Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools enables customers to remove the overall burden from QC labs
- From 10 days to 10 minutes
- More cost effective
- Point-of-use testing without requiring sites to have expensive testing technologies
Replacement of GC for Solvent Quantification
- Aqueous mixtures of solvents and water are commonly used in downstream processing of pharmaceutical products
- Current testing requires sending samples to the laboratory for GC analysis
Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools has been validated using production lots with results comparable to or superior to GC testing
- From 6 hours to 10 minutes
- More cost effective
- Point-of-use testing
- Aqueous mixtures of solvents and water are commonly used in downstream processing of pharmaceutical products
- Current testing requires sending samples to the laboratory for GC analysis
Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools has been validated using production lots with results comparable to or superior to GC testing
- From 6 hours to 10 minutes
- More cost effective
- Point-of-use testing
Raw Material ID with Handheld Instrumentation
- Currently samples taken from the manufacturing floor are sent to a centralized lab
- Labs generally have a backlog and products are put on hold until tests are complete
- Pharma industry is looking for faster release from analytical testing
- Thermo Scientific TruScan RM/GP Handheld Raman Analyzer and microPHAZIR RX Analyzer provide point-of-use solutions to replace existing testing workflows
- TruTools allows quantitative models to replace advanced in-process QC tests
- TruTools provides TruScan RM the ability to ID complex materials that handheld instrumentation previously could not perform
- Faster release
- No sampling, no queue
- Currently samples taken from the manufacturing floor are sent to a centralized lab
- Labs generally have a backlog and products are put on hold until tests are complete
- Pharma industry is looking for faster release from analytical testing
- Thermo Scientific TruScan RM/GP Handheld Raman Analyzer and microPHAZIR RX Analyzer provide point-of-use solutions to replace existing testing workflows
- TruTools allows quantitative models to replace advanced in-process QC tests
- TruTools provides TruScan RM the ability to ID complex materials that handheld instrumentation previously could not perform
- Faster release
- No sampling, no queue
API Quantification
- HPLC is currently used for API quantification that takes hours for each inspection
- HPLC creates solvent and disposal waste
- Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools provides a point-of-use solution with the same results as HPLC
- Increases production throughput
- Faster results
- Higher production capability
- Reduce lab material costs
- HPLC is currently used for API quantification that takes hours for each inspection
- HPLC creates solvent and disposal waste
- Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools provides a point-of-use solution with the same results as HPLC
- Increases production throughput
- Faster results
- Higher production capability
- Reduce lab material costs
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