GxP Analytical and Safety Testing for Biologic Batch Release and IND Submission

We’re developing a Section 351 biologic for an upcoming Investigational New Drug (IND) submission and are seeking a qualified laboratory to perform analytical and safety testing in support of batch release. We prefer a single laboratory to perform all required testing under applicable GxP requirements.

Required testing includes:

• Sterility Testing – USP
• Bacterial Endotoxin Testing – USP
• pH Testing – USP
• Osmolality Testing – USP
• Residual Moisture Determination – Karl Fischer titration

Please provide information on testing capabilities, sample requirements, turnaround times, and pricing. Testing is needed to support biologic batch release activities associated with the upcoming IND submission.