SPI USA : Portfolio of Projects - Pharma and Biotech Consulting Projects

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BioScience Contract Production Corp - SPI USA consultants assisted in the development of the successful bid to design, construct and operate the Maryland Bioprocessing Center in Baltimore, which was designed to meet FDA and European specifications. The facility has been inspected and approved by both the FDA and the EMEA. SPI USA, Inc. consultants also formulated and directed technical and CGMP regulatory input to the building design, equipment selection, utilities, interior finishes, and air quality/HVAC requirements. This facility is now part of Cambrex Corporation.

Bioreactor Validation for a Large BioPharma Company - SPI USA consultants provided consultation services to a major biopharmaceutical company on aspects of bioreactor validation. The facility was inspected and approved by the FDA and many foreign regulatory agencies, including European countries. (Pharmaceutical Manufacturer)

Definitional Mission for the India Cold Chain Technical Assistance Program - SPI USA performed a Definitional Mission (DM) for the India Cold Chain Technical Assistance (CCTA) Program sponsored by the United States Trade and Development Agency. The objective was to engage Indian importers and retailers that handle U.S. products in activities to facilitate improved handling of products throughout various stages of the cold chain, ultimately resulting in an increase in the value and volume of U.S. perishable food exports. SPI USA developed Scopes of Work for cold chain technical assistance programs in India in the amount of $500,000.

Technical Innovation Center (TIC) in Washington County - SPI USA consultants conducted a market and technical feasibility study for the Washington County incubator. The study assessed whether TIC should finance renovating existing wet lab facilities or expanding facilities by building an addition 3500 sq. ft. of wet lab space.

Small-Scale GMP Manufacturing Facility Study - SPI USA consultants assessed the market opportunity for establishing a small-scale CGMP biopharmaceutical manufacturing facility in the northern U.S. (Pharmaceutical Manufacturer)

BioPharma Patent Portfolio Assessment - SPI USA consultants conducted an assessment of a high technology company's patent portfolio. The assessment included an analysis of the global market opportunity for resulting products. (Private Investment Firm)

Colorado State University - SPI USA consultants provided a full review to the design of a Regional Biocontainment Laboratory with CGMP production capabilities at a Biosafety Level 3. SPI USA was also contracted for reviewing and advising on the design of the facility for CGMP compliance as well as to prepare the User Specification Requirements and validation requirements for the facility.

Strategic Biopharma Company Alliance - SPI USA assisted a European pharmaceutical company to enter the biotechnology industry by identifying biotechnology companies in the U.S. and Europe that were interested in strategic alliances and then facilitated discussions and interactions that lead to collaborative partnerships.

University of Maryland Bioprocess Scale-up Facility - SPI USA consultants conceived, designed and contracted for facility construction of fermentation, cell culture and protein purification pilot plant focused on process development and optimization. SPI USA consultants were also involved in the specification, purchasing and coordination of installation of bioproduction and purification equipment from 1-500 L scale. In addition, our consultants were involved with directing recent 2004 renovation and new equipment acquisition, including modernizing and upgrading facility and process capabilities, with emphasis on state of the art bioreactors and process chromatography skids.

U.S. Army Edgewood CGMP Production Facility - SPI USA consultants provided facility design and regulatory consultation, proposal reviews, site inspections and problem resolution support.

University of Maryland College Park - SPI USA consultants conducted a study on behalf of the University of Maryland College Park for a small business incubator on the College Park Campus, with laboratory and offices for biotechnology and other technology start-up companies (Technology Advancement Program). The study included designing a of 32,000 sq. ft. building that features 10 biotechnology (wet) labs as well as office and light manufacturing space.

University of Maryland College Park - SPI USA consultants conducted feasibility studies of several commercial buildings in the College Park area to assess their suitability and sustainability as "second stage" incubators. These studies incorporated review of existing building amenities, lighting, water and drains, public access and parking and current state of maintenance. These studies incorporated hypothetical models of retrofitted wet labs, technology offices and common spaces.

University of Maryland Biotechnology Institute, CARB II CGMP Processing and Training Facility - SPI USA consultants provided facility design and regulatory consultation including: layout, equipment and furnishings selection, interior finishes, HVAC design.