Rigorous Planning and Methodology

We have gained the trust and repeat business of large, international pharmaceutical companies and small biotechs alike. Together we design a project-specific Study Protocol which includes scope of work, SOPs, all project requirements, and deliverables. Both parties agree to and sign the Study Protocol. Our GLP services include:

• The GENEWIZ Quality System, developed in accordance with applicable FDA regulations described in Title 21, Part 58 of the Code of Federal Regulations for Good Laboratory Practice
• Technical consultation with dedicated Ph.D. Study Director
• Fully customized services
• Validated SOPs, equipment, and facility
• Internal and visiting audits
• Computerized sample handling procedures
• Elements of cGMP compliance (21CFR211, 600, ICH Q7A) to support biopharmaceutical manufacturing Quality Control testing
• Competitive Pricing

GENEWIZ Quality System

GENEWIZ's quality system is developed in accordance with applicable FDA regulations described in Title 21, Part 58 of the Code of Federal Regulations (CFR) for Good Laboratory Practice (GLP). In addition, our quality system includes elements of cGMP compliance (21CFR211, 600 ICH Q7A) to support biopharmaceutical manufacturing Quality Control testing.

GENEWIZ quality philosophy is to ensure that quality is built into all aspects of our services, to consistently satisfy the needs and expectations of our customers as a trusted partner in advancing their research and product development.

Case Study:

Regulatory DNA Sequencing to Support Cell Bank Characterization for FDA Submission

Client Profile
An international pharmaceutical, biopharmaceutical and medical device outsourcing company's customer was developing a biopharmaceutical agent. The company was characterizing Cell Banks for safety studies, with the ultimate goal to advance the studies through pre-clinical trials.

Business Needs
The company had a series of mammalian cell banks requiring GLP-level Cell Bank Characterization. Part of the requirements included confirmation of DNA identity and stability. The outsourcing company sought services that would return DNA and RNA sequences and documentation to comply with FDA regulations.

Technical Challenge
The company required the confirmation sequencing of transcripts from a stably transfected Master Cell Bank and an End of Production Cell Bank as well as the plasmid used in their development. The constructs had diverse structural characteristics that with conventional amplification and standard sequencing conditions would provide little usable sequence data.

GENEWIZ Solutions
GENEWIZ's Ph.D. Study Director worked directly with the client to ensure that the project scope and requirements were thoroughly discussed and agreed upon. Through this individualized interaction and study design, GENEWIZ developed a Study Protocol that fit the client's intricate plasmid construct as well as their strict requirements for Quality Assurance and turnaround time. They chose to use one of GENEWIZ's proprietary sequencing protocols to ensure high quality results. All of the client's requirements were met in a timely, reliable manner.

Results
By working closely with the client, GENEWIZ designed a strategy that addressed the complexities in the original constructs and returned high quality sequencing data from multiple sources. GENEWIZ exceeded all of the client's expectations in terms of ease of use, communication, quality, and turnaround time. The company has since submitted several additional projects, due to the outstanding evaluation of the completed GENEWIZ Study Report by their internal Quality Control Unit.