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January 7, 2020
Extractables and Leachables
Extractables and Leachables from Single Use Systems and Multi-Use Equipment Used in Pharmaceutical and Biotherapeutic Manufacturing
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October 1, 2019
Latest Posts
Extraction Study of a Cartridge Filter Based Upon the BioPhorum Operations Group (BPOG) Recommendation
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June 10, 2019
Extractables and Leachables
Simulated Use Extraction as an Alternative to Leachables Testing
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March 15, 2019
Features of PLL
Why Choose a Small CRO over a Top 10 CRO?
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March 15, 2019
Extractables and Leachables
Extractables and Leachables Testing
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March 15, 2019
PLL Experience
Quality Agreements
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March 15, 2019
PLL Experience
Analytical Methods For Single Entity Combination Products
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March 15, 2019
PLL Experience
Short Chain Fatty Acid Analysis
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March 15, 2019
Extractables and Leachables
Pharmaceutical Extractable and Leachable Studies
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March 15, 2019
FDA/USP Status
Cleaning Validation for Medical Devices: Establishing Cleaning Limits
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March 15, 2019
PLL Experience
Preparing to Adopt a Quality Agreement at a CRO: Check That Your Quality House is in Order
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March 15, 2019
Extractables and Leachables
Possible Outcomes of a Leachables Study
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March 15, 2019
Features of PLL
Dr. Michael Ruberto, E&L Retained Consultant
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March 15, 2019
PLL Experience
Bioanalytical Sample Preparation
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March 15, 2019
PLL Experience
Preparing to Adopt a Quality Agreement
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March 15, 2019
PLL Experience
Analysis of Oligonucleotides and Pegylated Oligonucleotides in Plasma by Ion-Exchange HPLC-UV
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March 15, 2019
Extractables and Leachables
Sources of Leachables
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March 15, 2019
Extractables and Leachables
Exaggerated Extraction of Medical Devices
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March 15, 2019
PLL Experience
Microbiome Research Support
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March 15, 2019
FDA/USP Status
FDA has finalized bioanalytical validation guidance
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March 15, 2019
Combination Testing
Evaluating the Drug Release/Elution from a Single Entity Combination Product
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March 15, 2019
Combination Testing
Stability Indicating Methods for Single Entity Combination Products
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March 15, 2019
FDA/USP Status
AET and Ophthalmic Drug Products
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March 15, 2019
FDA/USP Status
Update on the Status of USP <661.1> and <661.2>
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March 15, 2019
Extractables and Leachables
E&L Analytical Evaluation Threshold
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March 15, 2019
Extractables and Leachables
Injectable Vaccines and Related Biological Products Require E&L Testing
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March 15, 2019
Extractables and Leachables
Definition of an Extactables and Leachables
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March 15, 2019
Extractables and Leachables
Selection of the Drugs to be used to Evaluate Compatibility and Leachables for Infusion Devices
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March 15, 2019
Extractables and Leachables
PQRI SCT vs. ICH M7 TTC for AET Calculations
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March 15, 2019
Extractables and Leachables
E&L Assessments for Single and Multi-Use Manufacturing Equipment
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March 15, 2019
FDA/USP Status
USP <467> Residual Solvents Testing
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March 15, 2019
PLL Experience
Bioanalysis in Tissue and Biological Fluids
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March 15, 2019
FDA/USP Status
USP <232>
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March 15, 2019
Combination Testing
Evaluating Drug Product Compatibility with a Medical Device
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March 15, 2019
Combination Testing
Analytical Methods for Combination Products May Need to be Stability Indicating
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March 15, 2019
PLL Experience
Identification of Unknown Degradation Products and Process Impurities
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March 15, 2019
PLL Experience
Bioanalysis of Therapeutic Peptides by LC-MS/MS
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March 15, 2019
Extractables and Leachables
E&L for Injectable Vaccines and Related Biological Products
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March 15, 2019
Extractables and Leachables
E&L for Users of Single-Use Systems
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March 15, 2019
Extractables and Leachables
Regulatory Requirement for Extractable and Leachables from Medical Devices
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March 15, 2019
Combination Testing
Analytical Methods for Single Entity Combination Products VS Traditional Drug Products
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March 15, 2019
PLL Experience
NSF International Sells Local Lab to Bristol-Based Scientist
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March 15, 2019
Extractables and Leachables
E&L for Medical Devices
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March 15, 2019
Combination Testing
Analytical Challenges from combination products.
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March 15, 2019
Combination Testing
Type of combination products
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March 15, 2019
Combination Testing
Useful Reference for Combination Products
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March 15, 2019
Combination Testing
Combination Product Testing
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March 15, 2019
PLL Experience
Bioanalysis, Preclinical and Clinical
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All Blog Posts
Combination Testing
Extratables And Leachables
Features Of PLL
FDA/USP Status
PLL Experience
Recent Posts
January 7, 2020
Extractables and Leachables from Single Use Systems and Multi-Use Equipment Used in Pharmaceutical and Biotherapeutic Manufacturing
October 1, 2019
Extraction Study of a Cartridge Filter Based Upon the BioPhorum Operations Group (BPOG) Recommendation
June 10, 2019
Simulated Use Extraction as an Alternative to Leachables Testing
