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Facility

ASC Facility

State-of-the-Art Global Cell Manufacturing Facility

Milpitas, CA Headquaters
Located in the heart of Silicon Valley, the Applied StemCell facility in Milpitas, CA is the core location of ASC’s scientific and production operations.

cGMP Facility
Our cGMP operations are performed in 5 dedicated, individually isolated, qualified clean rooms with electronic access control and continuous monitoring. Each ISO 7 cleanroom is equipped with ISO 5 biological safety cabinet(s), CO2/humidity controlled and remotely monitored incubators, and centrifuge. The cleanrooms can be individually configured and qualified with equipment specific to your process requirements, such as automated wash and separation units, cell sorters, bioreactors, filling equipment, etc.

Quality Control tests for cGMP projects are performed in a spacious, tightly access-controlled laboratory with dedicated and validated QC equipment such as automated cell counters, flow cytometer, ELISA plate reader, and qPCR among other equipment and instruments to support cell-based assays, safety testing, and a separate room for incubation of environmental monitoring samples.
In support of cGMP manufacturing, we have dedicated, controlled and monitored GMP storage areas with a range of storage temperatures from vapor phase LN2, -80°C, -20°C, 2-8°C, and controlled room temperature, as well as areas for receiving and quarantine of incoming materials prior to release. Released materials flow to a kitting room where their packaging is cleaned and assembled in kits for each custom project before passing-through to the cleanroom suites.

Our cGMP facility and operations are managed according to FDA and ICH regulations and guidance for cell and gene therapy manufacturing using a validated electronic quality management system (eQMS) and an automated monitoring and alert system to track environmental conditions in facilities and equipment, as well as room pressure differentials. Our facility is licensed by the California Department of Public Health, and our quality systems have been certified under ISO:13485 since 2017.

We have plans and space available to grow our cGMP operations to include 5 additional, EMA Annex 1 compliant cleanrooms, along with additional cGMP QC and materials management space.
Contact us to learn how we can support your GMP clinical manufacturing project!

CRO and Research-Grade Production Facility
Separate from our cGMP operations, our CRO and research grade production operations occur across multiple laboratories (~10,000 ft2) equipped for cell culture, molecular biology, analytical testing, controlled storage, and shipping. Our facility in Silicon Valley has a strong track record with over 15 years and thousands of successfully-completed projects supporting cell and molecular biology researchers and product developers from leading companies, prestigious academic institutions, and federal and state standard-setting bodies in the USA and around the globe.

Cell biology laboratories house equipment such as biosafety cabinets, electroporation systems, CO2 incubators, centrifuges, fluorescence imaging microscopes, FACS instruments, dry and water baths, etc. to support research production and analytical operations. Our high-throughput automation system for gene editing includes an imaging system and Hamilton liquid handler/colony picker.
Our molecular biology labs include 30 benches dedicated to molecular biology work. The laboratories have all the necessary equipment and tools including NGS, ddPCR, qPCR, gradient PCR, electroporators, centrifuges, gel electrophoresis and imaging systems, spectrophotometers, freezers and refrigerators.

US Animal Facility
Applied StemCell’s animal operations and expert team are based in facilities and vivariums operated by the Oklahoma University Health and Science Center (OUHSC) with veterinary oversight by the OUHSC Division of Comparative Medicine. Protocol review and approval is performed by the OUHSC Office of Animal Welfare Assurance, and program oversight by the OUHSC Institutional Animal Care & Use Committee (IACUC). The facility is registered with the United States Department of Agriculture (USDA), Animal and Plant Inspection Service (APHIS), Animal Care (AC) as a federally approved research facility, assured through the NIH Office of Laboratory Animal Welfare (OLAW) and accredited through AAALAC, holding full accreditation status since 1973.

MTA Agreement

Material Transfer Agreement

IMPORTANT! PLEASE READ CAREFULLY BEFORE SUBMITTING AN ORDER. THIS IS A CONTRACT.

This Material Transfer Agreement (“MTA”) is between you (“Purchaser”) and the Applied StemCell, Inc. a California company, having its principal place of business at 521 Cottonwood Drive Suite 111, Milpitas, CA 95035 USA (“ASC”). Purchaser must have an approved, current ASC account to place an order. This MTA is effective for a period of five (5) years as of the last date of execution by the parties and governs the purchase and use of all ASC Materials under the terms and conditions set forth below.

TERMS AND CONDITIONS

Definitions

“ASC Material(s)” means materials acquired from ASC as documented on an ASC Sales Order, such as iPS Cell lines.

"ASC Sales Order" means an order submitted for ASC Materials in a form and format as determined by ASC from time to time. "Biological Material(s)" means ASC Materials, Progeny, Unmodified Derivatives and Modifications, either individually or jointly. "Commercial Use" means the sale, license, lease, export, transfer or other distribution of the Biological Materials to a person or entity not party to this MTA for financial gain or other commercial purposes and/or the use of the Biological Material: (a) to provide a service to a person or entity not party to this MTA for financial gain; (b) to produce or manufacture products for general sale or products for use in the manufacture of products ultimately intended for general sale (c) in connection with ADME (Absorption, Distribution, Metabolism and Excretion) testing; (d) in connection with drug potency or toxicity testing (e) in connection with proficiency testing service(s), including but not limited to, providing the service of determining laboratory performance by means of comparing and evaluating calibrations or tests on the same or similar items or materials in accordance with predetermined conditions; or (f) for research conducted under an agreement wherein a for-profit entity receives a right whether actual or contingent to the results of the research. Commercial Use specifically does not include Industry Sponsored Academic Research.

“Contributor(s)” means an organization(s) and/or individual(s) providing original material to ASC for deposit.

"Industry Sponsored Academic Research" means research sponsored by a for-profit organization carried out at a non-profit organization and by the non-profit organization’s employees. "Investigator" means the Purchaser’s principal scientist or researcher using the Biological Material(s). "Modification(s)" mean substances created by Purchaser which contain and/or incorporate a significant or substantial portion of ASC Material. "Progeny" means an unmodified descendant from the ASC Materials, such as virus from virus, cell from cell, or organism from organism. "Purchaser(s)" means the organization purchasing and receiving ASC Material pursuant to this MTA. "Unmodified Derivative(s)" mean substances created by Purchaser that constitute an unmodified functional sub-unit or product not changed in form or character and expressed by the ASC Material provided by ASC. Unmodified Derivatives include, but are not limited to, subclones of unmodified cell lines, purified or fractionated subsets of materials provided by ASC, proteins expressed by DNA/RNA supplied by ASC, or monoclonal antibodies secreted by a hybridoma cell line.

Scope of Use

Subject to the terms of this MTA, Purchaser’s Investigator may make and use the Biological Materials provided to Purchaser by ASC for research purposes only in Purchaser’s Investigator’s laboratory only. The Biological Materials are not intended for use in humans. Purchaser agrees that Biological Materials designated as biosafety level 2 or 3 constitute known pathogens and that other Biological Materials not so designated may be pathogenic under certain conditions. Purchaser assumes all risk and responsibility in connection with the receipt, handling, storage, disposal, transfer and Purchaser’s use of the Biological Materials including without limitation taking all appropriate safety and handling precautions to minimize health or environmental risk. Purchaser agrees that any activity undertaken with the Biological Materials will be conducted in compliance with all applicable guidelines, laws and regulations, and that Purchaser will obtain all permits, licenses or other approvals required by any governmental authority in connection with purchaser’s receipt, handling, storage, disposal, transfer and use of the Biological Materials.

Purchaser shall not distribute, sell, lend or otherwise transfer to a person or entity not party to this MTA the Biological Material, as defined above, for any reason, without ASC’s prior written agreement.

Any Commercial Use of the Biological Material is strictly prohibited without ASC’s prior written consent. Purchaser acknowledges and agrees that Purchaser’s use of certain Biological Material may require a license from a person or entity not party to this MTA, or be subject to restrictions that may be imposed by a person or entity not party to this MTA (“Third Party Terms”). To the extent of ASC’s knowledge of the existence of any such applicable rights or restrictions, ASC will take reasonable steps to identify the same, either in ASC’s catalog of ASC Materials and/or through ASC’s customer service representatives, and to the extent they are in the possession of ASC, ASC shall make information regarding such Third Party Terms reasonably available for review by Purchaser upon request. Purchaser expressly acknowledges that if there is a conflict between this MTA and the Third Party Terms, the Third Party Terms shall govern. Use of the Biological Materials may be subject to the intellectual property rights of a person or entity not party to this MTA, the existence of which rights may or may not be identified in the ASC catalog or website, and ASC makes no representation or warranty regarding the existence or the validity of such rights. Purchaser shall have the sole responsibility for obtaining any intellectual property licenses necessitated by its possession and use of the Biological Materials.

The use permitted under this MTA for Industry Sponsored Academic Research extends only to the academic research carried out at the non-profit organization and the non-profit organization’s employees. Any non-profit Purchaser using the Biological Materials in connection with Industry Sponsored Academic Research agrees to notify the industrial sponsor that any use of the Biological Materials by the industry sponsor will require a separate license from ASC and/or its Contributors and that ASC and/or its Contributors are under no obligation hereunder to license any Biological Materials to any such industry sponsor.

Warranty; Warranty Disclaimer

ASC warrants that (a) cells and microorganisms included in the ASC Material shall be viable upon initiation of culture for a period of thirty (30) days after shipment thereof from ASC and (b) any ASC Material other than cells and microorganisms shall meet the specifications on the applicable ASC Material product information sheet, certificate of analysis, and/or catalog description until the expiration date on the applicable ASC Material’s product label (such thirty (30) day period, or period until the expiration date, referred to herein as the “Warranty Period”). Purchaser’s exclusive remedy, and ASC’s sole liability, for breach of the warranties set forth in this paragraph is for ASC to, at ASC’s sole option, either (i) refund the fee paid to ASC for such ASC Material (exclusive of shipping and handling charges), or (ii) replace the ASC Material. The warranties set forth in this paragraph apply only if Purchaser handles and stores the ASC Material as described in the applicable ASC Material product information sheet. To obtain the exclusive remedy, Purchaser must report the lack of viability or non-conformation to specifications to ASC’s Technical Service Department within the applicable Warranty Period. Any expiration date specified on the ASC Material shipment documentation states the expected remaining useful life, but does not constitute a warranty or extend any applicable Warranty Period. Except as expressly provided above, the ASC Material and any technical information and assistance provided by ASC are provided as-is, without warranties of any kind, express or implied, including but not limited to any implied warranties of merchantability, fitness for a particular purpose, typicality, safety, accuracy and/or non-infringement.

Purchaser acknowledges that the ASC Material and any technical information and assistance provided by ASC are developed and provided exclusively for research purposes, and Purchaser agrees to use the same at its sole risk. Purchaser agrees that ASC and its Contributors will not be liable for any loss, claim or demand made by Purchaser, or made against Purchaser by any other party, due to or arising from the use of the ASC Material by Purchaser, except to the extent permitted by law when caused by the gross negligence or willful misconduct of ASC.

Limitation of Liability

In no event shall ASC or its Contributors be liable for any use of the Biological Material by Purchaser, for any loss, claim, damage, or liability, of whatever kind or nature, which may arise from or in connection with this MTA or the use, handling, storage, or disposal of the Biological Material. ASC’s liability to Purchaser for any claim related to or arising from this MTA or the Biological Material, whether in contract, warranty, tort, or otherwise, shall be limited to the amount paid by Purchaser for the Biological Material. In no event shall ASC be liable for any indirect, special, incidental, consequential, or punitive damages, including without limitation, loss of profits or loss of use, even if ASC has been advised of the possibility of such damages. The limitations of liability set forth in this MTA shall survive termination or expiration of this MTA for any reason.