Fermentation. Upon completion of the 30L trial, and concurrent with the work to prepare the purified Urease, the first 500-1000 L Engineering batch will commence. The 50 gram conjugate deliverable will require 25 grams of purified AFAIK2. Pending yields this may require 2 × 500 L batches to be performed or a single batch performed at the required volume in a 1000 L fermentor. A new continuous centrifuge and microfluidizer will be qualified for the process at this stage. The fermentation will be performed using preliminary batch records to ensure the accepted protocol is followed; additional testing of samples or data collection can be recorded in laboratory notebooks. Site cGMP API Facility Fermentor (s) 30 L (22L working) 500 L (350 L working) Time 7 days Documentation Draft Batch records, draft QC methods and notebooks Deliverables Completed batch records, QC reports and Development report
Fermentation a. All pipe and tank construction to be of 304 stainless steel. b. Fermenter capacity; minimum three (3) tanks at 800,000 gallons each. c. Individual Fermentation Coolers. d. Top mounted agitation in Fermentation tanks. e. Beerwell capacity is 1,000,000 gallons. f. CIP system. g. Enzyme Tank capacity; 3 tanks of _____ gallons capable of receiving Bulk Delivery of ALPHA Amalase, Gluco Amalase and Sulfuric Acid. h. Yeast propagation capacity.
Fermentation. The fermentation in the R&D laboratory will be performed at the 20 litres scale that is directly scalable to 300 litres owing to our extensive experience of E. coli processes. The purpose of the fermentation will be (1) to master the process developed by Xx. Xxxxx and (ii) to provide material for the down stream processing (DSP). Two fermentations have been programmed with the process of Xx Xxxxx. The protocol will be superstitiously reproduced in every details. A third one will be done if the parameterisation of the fed batch flow is more difficult than expected. As soon as the DSP has reproduced the process and the QC as established the necessary assays to qualify the protein, a fermentation will be performed according to our standard fermentation formula. It has been improved for years and has always been superior to what our sponsors have provided. During our meetings, we have expressed some concerns on the fermentation protocol used so far which appears to us to be outdated and not usefully complex, hence with some consistency issue. If our standard formula yields similar amount of best quality protein, we will propose to you to change for our simpler and more efficient protocol. If not, we will continue with the current method. As soon as the fermentation protocol is implemented in the laboratory, it will be transferred to the production unit. Two fermentations are planned to first confirm the scalability of the process second, to set the harvest parameters. So far the bacterial cells were harvested as a solid paste, this is impossible with our equipment at the 300 litres scale. The continuous centrifuge yields highly enriched cell suspension in buffer. Will this buffer exchange in the centrifuge be sufficient to go on with the process and how many cycles will be necessary to achieve sufficient medium removal. The cells harvested at this stage will be directly transferred to the R&D DSP laboratory for further processing and assessment of quality. The first step of full-scale liquid-liquid extraction and filtrabiity of the pro-APO Al fraction will be tested at this stage. The purchase of two large volume centrifuge will be necessary to run the process at the 300 litres scale. Two more 300 litres fermentations are planned for further consistency and to provide adequate material for the first full-scale purification, see annexed Xxxxx chart (Esperion total). At the completion of these assays, the fermentation process, harvest and extraction will be read...
Fermentation. Process Scale Up will verify that the fermentation conditions, growth and productivity of the organism, of Streptoverticullium cinnamoneus provided by Molichem are reproducible at AFI. This effort may be in part or wholly combined with Phase I Microbiology. Use or disclosure of the data contained on this sheet is subject to the restriction on the title page of this proposal.
Fermentation. The preparation, charge-in, sterilization inoculation, cultivation and subsequent harvest of the Moli1901 producing culture will be conducted in accordance with the pre-approved master batch records.
Fermentation. Update the DCS system to enable control on the fermenter/yeast prop enzymes and fermentation temperature controllers and data entry for the fermentation HPLC results. Installation of a real-time HPLC sampling, trending and communication protocol between DCS or Pavilion computer and the laboratory HPLC assumed. • Execute fermentations over two weeks with the described online analyzers testing with optimal fermentation trajectories as calculated by the Pavilion offline fermentation optimization models.
Fermentation. Kosan expects to improve the now existing engineering space and possibly an additional 1000 sq. ft. to accommodate fermentation equipment for the production of research and/or GMP grade products. This improvement will require, but is not limited to, the installation of central steam generating equipment and associated plumbing, drainage plumbing and channels, waste disposal equipment, HVAC improvements and ducting, plumbed central gases, routing of electrical and water lines, alteration to the existing drop ceiling, and upgrade of flooring to epoxy resin. EXHIBIT E IMPROVEMENTS AND EQUIPMENT TO BE REMOVED BY SUBLESSOR Bio safety Cabinets Portable Equipment Dehumidification Units/Condensers Autoclave Glassware Washer Glassware Dryer Warehouse Racks Data Networking Equipment, less cabling Critical equipment monitoring system Laminar Flow Hoods Library racks De-ionized water system purification bottles
Fermentation evaporation, loss of weight, contamination or change in quality (except where such is directly caused by an occurrence which is not otherwise excluded)