Understanding PDA Technical Report No. 82: A Guide to Low Endotoxin Recovery (LER)

What are Extractables and Leachables?

Scope: This feature applies to Quality Control (QC), Analytical Development, and Manufacturing Science & Technology (MSAT) for monoclonal antibodies (mAbs), ADCs, and other biologic drug substances/products stored in containers (e.g., stainless steel, plastic, syringes). pda technical report 82 pdf

2. Standardized Methodologies
The report details protocols for “spike and hold” studies using a relevant container-closure system. Crucially, it introduces two recovery benchmarks: Understanding PDA Technical Report No

3. Validation Protocols for Low Bioburden vs. Sterile

This is the "meat" of the report. TR-82 differentiates validation requirements: pda technical report 82 pdf

• Acid-labile mAbs (aggregators)
• Bispecifics
• ADCs with labile linkers
• Viral vectors (AAV/Lentivirus)

4. Regulatory Alignment

TR 82 is written to align with major global regulatory standards, including: