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		Bio – Pharmaceuticals Project

Biopharmaceutical Project in India

Client Name	: -	Confidential Client
Project Location	: -	US Based MNC
Scope of Services	: -	– Review of PFD, Mass Balance and Equipment Sizing – Preparation of Basis of Design Document – Ensuring Compliance to Local Regulations – Layout Review – URS Review – Technical Recommendation – Project Schedule Preparation and Tracking

Spectrum partnered with US based process engineering firm for this project. Spectrum’s role was to understand the process design and review the suitability of the existing facility in India for Implementation of project and ensure the compliance to local regulations in India.

The project was to set up the PEGylation facility to produce non sterile PEGylated API followed by sterilization and filling the PEGylated API in syringe. The product was aimed at clinical trial in regulated market followed by commercial launch for regulated market.

The first phase involved transfer of process to Indian CMO. Spectrum’s role was to review PFD, Material Balance, equipment sizing and layout. Basis of design document was prepared based on this information and site constrains.

The second phase involved review of User Requirement Specifications (URS) for the equipments which Included, Reactor, online dilution skid, chromatography column, chrome skid and UF/DF Skid.

Spectrum’s role was to ensure that URS have adequate and correct information and allow opportunity to all vendors to offer their systems meeting the URS. Spectrum was also involved in vendor selection and technical recommendation.

Spectrum was involved in development of detailed project schedule mapping all activities and responsibilities from tech transfer stage to commercial product launch. Spectrum was involved in weekly review of the progress.