Fermentation Sample Clauses

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During our meetings, we have expressed some concerns on the fermentation protocol used so far which appears to us to be outdated and not usefully complex, hence with some consistency issue.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. 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)

Related to Fermentation

  • Fabrication Making up data or results and recording or reporting them.

  • Production Lessee shall, subject to applicable laws, regulations and orders, operate and produce all xxxxx upon the leased land so long as the same are capable of producing in paying quantities, and shall operate the same so as to produce at a rate commensurate with the rate of production of xxxxx on adjoining lands within the same field and within the limits of good engineering practice, except for such times as there exist neither market nor storage therefore, and except for such limitations on, or suspensions of, production as may be approved in writing by Lessor. Lessee shall be responsible for adequate site security on all producing properties.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Plant UBEF and its agents shall be given access to the Plant in a manner and at all times reasonably necessary and convenient for UBEF to take delivery as provided herein. UBEF shall schedule the loading and shipping of all Ethanol purchased hereunder, whether shipped by truck or rail. All labor and equipment necessary to load or unload trucks or rail cars shall be supplied by EKAE without charge to UBEF. The parties agree to handle the Ethanol in a good and workmanlike manner in accordance with the other's reasonable requirements and in accordance with normal industry practice. EKAE shall maintain the truck/rail loading facilities in safe operating condition in accordance with normal industry standards.

  • Insulin Insulin will be treated as a prescription drug subject to a separate copay for each type prescribed.

  • Testing Landlord shall have the right to conduct annual tests of the Premises to determine whether any contamination of the Premises or the Project has occurred as a result of Tenant’s use. Tenant shall be required to pay the cost of such annual test of the Premises; provided, however, that if Tenant conducts its own tests of the Premises using third party contractors and test procedures acceptable to Landlord which tests are certified to Landlord, Landlord shall accept such tests in lieu of the annual tests to be paid for by Tenant. In addition, at any time, and from time to time, prior to the expiration or earlier termination of the Term, Landlord shall have the right to conduct appropriate tests of the Premises and the Project to determine if contamination has occurred as a result of Tenant’s use of the Premises. In connection with such testing, upon the request of Landlord, Tenant shall deliver to Landlord or its consultant such non-proprietary information concerning the use of Hazardous Materials in or about the Premises by Tenant or any Tenant Party. If contamination has occurred for which Tenant is liable under this Section 30, Tenant shall pay all costs to conduct such tests. If no such contamination is found, Landlord shall pay the costs of such tests (which shall not constitute an Operating Expense). Landlord shall provide Tenant with a copy of all third party, non-confidential reports and tests of the Premises made by or on behalf of Landlord during the Term without representation or warranty and subject to a confidentiality agreement. Tenant shall, at its sole cost and expense, promptly and satisfactorily remediate any environmental conditions identified by such testing in accordance with all Environmental Requirements. Landlord’s receipt of or satisfaction with any environmental assessment in no way waives any rights which Landlord may have against Tenant.

  • Samples Physical examples of materials, equipment, or workmanship that are representative of some portion of the Work and that establish the standards by which such portion of the Work will be judged. The Contractor shall furnish for approval all samples required by the Contract Documents. The Work shall be in accordance with approved samples.

  • Validation ‌ Within one (1) year after the effective date of this contract, the Agency shall submit this contract to a court of competent jurisdiction for determination of its validity by a proceeding in mandamus or other appropriate proceeding or action, which proceeding or action shall be diligently prosecuted to final decree or judgment. In the event that this contract is determined to be invalid by such final decree or judgment, the State shall make all reasonable efforts to obtain validating legislation at the next session of the Legislature empowered to consider such legislation, and within six (6) months after the close of such session, if such legislation shall have been enacted, the Agency shall submit this contract to a court of competent jurisdiction for redetermination of its validity by appropriate proceeding or action, which proceeding or action shall be diligently prosecuted to final decree or judgment.

  • Probes Network hosts used to perform (DNS, EPP, etc.) tests (see below) that are located at various global locations.

  • Technical Specifications 1. A procuring entity shall not prepare, adopt or apply any technical specification or prescribe any conformity assessment procedure with the purpose or the effect of creating unnecessary obstacles to international trade.