Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
post
page
product

cGMP Cell Manufacturing

Complete GMP iPSC & MSC Platform

GMP & ISO-compliant Cleanrooms

Working & Master Cell Banks

Scale-up Services

Clinical Drug Substance & Drug Product Manufacturing

Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support? 

Gene and cell therapies are paradigm changing, new therapeutic genomic medicine. This makes the CMC and regulatory landscape quite complex to navigate successfully compared to small or large molecule-based therapies. Especially in cell manufacturing, you may encounter various challenges, but you don’t have to face them alone. ASC’s GMP experts can guide you through every step of the process from technology transfer, engineering run, analytical method qualification, scale-up, and GMP production. We can help you develop your project outline and ensure you receive detailed updates as we collaborate on your project until it is completed.

At our cGMP-compliant facility, we offer custom cell therapy manufacturing service options, including:

  • Cell product development: iPSC genome editing and differentiation
  • iPSCs and differentiated cell lines: customer provided or ASC’s GMP-grade iPSC Master Cell Lines
  • Gene editing: a wide range of genetic modifications leveraging a variety of gene editing technologies such as our proprietary TARGATT™™™, MAD7 and Accubase; also includes GMP Plasmid DNA Production scaled for gene editing use
  • Scale-up and Cell banking: Seed cell banking, working cell bank and master cell bank services
  • Fill/Finish: Formulate, fill, and finish per your specifications
  • In-process and release testing: Wide range of QC capabilities available for GMP and characterization testing

Our team can help you overcome CMC challenges and has the experience to advise on operational, logistic, quality and regulatory considerations for successful IND / CTA submissions and clinical supply. Our cGMP facilities are compliant for:

  • FDA compliant cleanrooms per ISO standards (ISO 7 rooms with ISO 5 workspaces) with readily available space to expand
  • Continuous electronic monitoring and trending of key equipment and facilities
  • Dedicated GMP areas with electronic access control
  • Validated eQMS ensuring data integrity and traceability
  • Clinical drug substance and drug product manufacturing

Comprehensive iPSC-derived Cell Product Manufacturing

Our one-stop cGMP-compliant, iPSC Cell Product platform spans the whole range of iPSC related activities from iPSC generation, gene editing, differentiation and further to cryopreservation and cell banking.

GMP Service Options

GMP Service Options

  • GMP-grade, TARGATT™™TM iPSC Master Cell Lines: With landing-pad ready to knock-in your gene of interest and differentiate to isogenic, allogeneic iPSC-derived cell products
  • cGMP iPSC Line Generation: We can reprogram healthy donor or patient-sourced somatic cells to iPSCs using footprint-free episomal or sendai virus method under GMP conditions; we can use our high-efficiency protocols or a reprogramming method of your choice to generate novel iPSC lines.
  • gmp_targattipsc_ink_cell-product_generation_processGMP-compliant iPSC Gene Editing: with a plethora of gene editing technologies such as TARGATT™™™, MAD7, and Accubase, we leverage our established gene editing foundation in iPSCs to engineer mainstream to complex genetic modifications in iPSCs under GMP conditions to advance your cell and gene therapy pipeline
  • GMP-grade, off-the-shelf iPSC Master Lines: Choose for our GMP-grade master cell lines with proven gene editing and differentiation capabilities as a starting material for your product or as controls for your assay and analytical method development

MSC Cell Product Manufacturing

Mesenchymal stem cells are a popular choice for cell therapy starting material due to their potential to differentiate into multiple lineages. At ASC, we offer end-to-end stem cell solutions, including cell isolation, expansion and banking, characterization, and differentiation.

  • MSC isolation from different sources: From umbilical cord blood and stroma, adipose tissue, placenta, bone marrow & dental tissues in GMP clean rooms
  • MSC master cell banks and working cell banks: Fast turnaround times; includes 2D and 3D scale-up manufacturing
  • MSC gene editing: lentiviral mediated gene editing expertise
  • MSC drug product manufacturing: Technology transfer, method validation, cGMP controls and documentation for clinical IND filing
  • iPSC differentiated MSC product manufacturing: Custom differentiation of iPSC to MSC and further to osteogenic and chondrogenic lineages

Primary Cell Product Manufacturing

ASC also offers primary cell isolation, cell banking and cell product manufacturing, featuring primary T cells, NK cells, monocytes, hematopoietic stem cells, etc.

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.