Amendment to Solicitation W911QY-09-R-0056 - Hollow Fiber Bioreactor

Solicitation W911QY-09-R-0056 is amended. Refer to website below to download actual amendment. Amendement 0001 updates proposal submission date and certain salient characteristics as follows:

The required response date/time has changed from 28-Aug-2009 11:59 PM to 26-Aug-2009 11:59 PM.

The following solicitation language is hereby modified on page 33, Statement of Work, Paragraph 1 General Scope, salient charactersitics:

REPLACE: (d) capable of producing viable cell densities in excess of 200 Million cells/ml per week WITH: (d) Capable of maintaining viable cell densities in continuous, perfusion culture for a minimum of 30 days

REPLACE: (e) capable to rapidly produce (in less than 24 hrs) gram quantities of fully glycosylated monoclonal antibodies WITH: Capable of producing up to 15 grams per month (depending on secreting cell line) of flully glycolsylated monoclonal antibodies at concentrations severalfold higher than conventional methodologies

REPLACE: (f) capability to rapidly and automatically purify monocolonal and idiotyptic antibodies WITH: (f) fully-compatible and linked purification component with the capability to rapidly and automatically purify IgG and IgM monoclonal antibodies (self-contained downstream device).

REPLACE: (g) self contained device occupying a benchtop space of 27 inches wide and 20 inches deep; weighing approximately 40 lbs; and operating on 110v WITH: (g) Self-contained upstream (cell culture) component enclosed within a footprint of less than 3 ft2 with the following features: weight approximately 75 pounds; 120v AC; enclosed single-use, disposable bioreactor cultureware. System shall be fully automated with feedback control of metabolites to minimize technician interaction and reduce risk. Password controlled software for security, capture of process conditions and generation of electronic batch records. Standard browser interface to monitor and control multiple instruments from remote location.

ADD NEW SALIENT CHARACTERISTIC: Self contained downstream component contained within a footprint of less than 3 sqft with the following features: weight pproximately 80 pounds; 120v AC; enclosed single-use, disposable purification cultureware. System is fully automated with valve switching capability such that effluent and eluent is controlled per defined process that automates buffer exchange, filtration and concentration to create a purified final product. Capable of multiple cycles to accommodate gram quantities of final product.