919-827-0933 info@manganbio.com

Automation, Compliance & CQV Professionals

Mangan Biopharm provides professional Automation, CQV, and Compliance services to the Life Sciences Industries (Pharmaceutical, Biotechnology, Nutrition, and Veterinary Products).

contact us today to find out how we can help you with your project needs.

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  • Program Development
  • Policy & Procedure Development
  • Auditing
  • Remediation

Bulk Complex Formulation Suite Commissioning & Qualification Support

Bulk Formulation Commissioning and Qualification Project Management

Clinical Manufacturing Suite and QC Laboratory Buildup

Clinical Manufacturing Suite and QC Laboratory Buildup Duration- 12 months Overview Built and started a clinical manufacturing suite and supporting QC laboratory for a clinical stage pharmaceutical company.  The engineering scope of work involved process, mechanical...

Particle Monitoring System Integration

Client: Major Global Pharmaceutical Corporation Project Duration: 3 months Overview: Mangan was contracted as a final attempt to integrate an automated particle monitoring system for a large pharmaceutical manufacturing facility, located in the Eastern USA Three...

Process Development Laboratory CQ&V

Process Development Laboratory Commissioning, Qualification and Validation Duration- 14 months Overview: Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new PD laboratory, within an existing biopharmaceutical commercial/clinical...

Control System Upgrade: Lyophilizers

Control System Upgrade for Production Lyophilizers Duration- 6 months Overview: Upgrade the existing control system for production lyophilizers at a large biotech company. Scope of Work: The project scope included: PLC and HMI Upgrade for Multiple Lyophilizers...

Bulk Manufacturing Process Cleaning Validation

Bulk Manufacturing Equipment Train Cleaning Validation Duration- 8 months Overview: Developed and performed cleaning validation of a new manufacturing process implemented at a international pharmaceutical site to improve process yields.  A full evaluation of their...

Cell Culture & Purification Manufacturing Suites CQ&V

Cell Culture & Purification Suites Commissioning, Qualification and Validation Duration- 12 months Overview: Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new Cell Culture and Purification manufacturing suites within an existing...

TrackWise Modifications for Change Management

Commission and Qualify the new Change Management group of workflows in TrackWise/Quest. The new Change Management project included 5 workflows (3 new and 2 modifications of existing workflows). The Change Management workflows will be utilized at three sites and qualified for use at each division and additionally as a global division for managing changes shared across sites.

Primary Packaging Line Cleaning Validation

Project: Cleaning Validation Program Development Primary Packaging     Duration- 4 months Overview: Developed the cleaning validation program and performed cleaning validation at a multi-product drug product repacker with over 90 different active ingredients. ...

Autoclave Revalidation Project

Autoclave Revalidation Project Duration- 9 months Overview During a concurrent project onsite at a major international pharmaceutical corporation, Mangan personnel were asked to evaluate the client’s Autoclave Program as a result of a regulatory audit.  Our...

Facility Expansion/Modification

Client: Major Global Pharmaceutical Corporation Project Duration: 12 months Overview: Mangan was contracted to provide integrated Commissioning and Qualification services for a large pharmaceutical manufacturing facility, located in the Eastern USA Scope included: ...

Mangan Biopharm Cary

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Contact Us

If we can help you in any way, please complete the  More Information form and one of our specialists will contact you to discuss your specific needs and how Mangan can help you achieve your project goals.

West Region

trahimian@manganinc.com

(310) 835-8080 Ext. 217

3901 Via Oro, Long Beach, CA 90810

Eastern and Midwest Regions

mtedder@manganinc.com

(919) 827-0933

201 Shannon Oaks Circle Suite 125 Cary, NC 27511

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