Quality Assurance & Control

Quality Assurance

WCBF Quality Assurance is committed to assuring that operations are performed to the highest quality principles. The Quality Assurance Department has the responsibility for ensuring that WCBF systems for the manufacture and testing of product for use in animal studies and phase I/II human clinical trials are in compliance with FDA and other regulatory requirements.

WCBF Quality Assurance has four primary functions:

Batch Release

• Review and approval of Standard Operating Procedures, Master Production and Control Records, Batch Production Records, Master Specifications, and Certificates of Analysis.
• Release of manufactured product as well as purchased raw materials.

cGMP Documentation

• Issuance and control of GMP documentation.
• Manage batch record and documentation archives.
• Maintain training files for WCBF personnel

Audit

• Perform audits, both on-site and by mail, of suppliers and contract laboratories.
• Act as the main contact for audits by potential clients and assure timely response to resulting observations.

Investigations and CAPA

• Assure the timely completion of investigations
• Assign and approve CAPA’s and assure adequate close-out and effectivity

Quality Control

The WCBF Quality Control Department has facilities and personnel to perform a comprehensive range of analytical testing services to ensure product quality and consistency during all stages of development and manufacturing.
Tests performed in the WCBF Quality Control department include:

• HPLC Quantitation of Plasmid DNA
• RP-HPLC
• SEC-HPLC
• LAL Test for Bacterial Endotoxin via Kinetic Turbidimetric Assay
• UV/Vis Spectrophotometric assays
• Identification testing
• BCA Test for protein
• Bradford Assay for protein concentration
• PCR assay development capabilities
• SDS-PAGE, Western Blot
• Isoelectric Focusing gels
• Restriction Digest and AGE of DNA Fragments
• Identity and Quantitation of Supercoiled DNA by Agarose Gel
• dsDNA Assay
• ELISA assays for host cell protein, p24, benzonase
• Adenovirus Rapid Titer and Plaque assays

Some of the microbiological services offered include:

• Sterility testing
• Antibiotic Sensitivity Studies
• Microbial Limits/Bioburden studies
• Cell Count Determination