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Product General Information

INCELL is dedicated to bringing quality products to biomedical applications and has the following types of kits, media, reagents, and cell products:

  • Products for sale: GMP manufactured culture media, cryopreservation media and supplements made by sterile liquid fill procedures and kits used to collect tumor cells and stem cells. Go to www.incellonline.com for more details.

  • Products for licensing or availability for collaborative research by Material Transfer Agreements: Cell lines and platform technologies can be licensed for a fee or are made available through MTAs. Send an email to MTACLA@incell.com to request information.

  • Products in its development pipelines: INCELL has products in its development pipeline in the areas of stem cells, cancer, regenerative medicine, non-needle and other vaccines, diagnostics, and therapeutics.

  • Products manufactured for customers: INCELL has GMP level manufacturing facilities for cells, cell-released products, sterile liquid fill, and microbiological products, including vaccines.

Business Numbers, Registrations and Certifications

DUNS#: 965420953

NAICS Codes: 325414, 325413, 325411, 541380, 541690, 541710, 541711, 541990

Registrations:

  • FDA as a manufacturer

  • Central Contractor Registry for US government

  • www.grants.gov for government grants from the National Institutes of Health (NIH), Department of Defense (DoD) and other entities

  • USDA for its animal facilities

Certifications:

  • SBA as a small, disadvantaged business (SDB) and a women-owned business (WBE)

  • SCTRCA as SBE/WBE #208035138

  • Statre of texas HUB Vendor #68402

  • ENV for manufacturing facilities and equipment


Frequently Asked Questions (FAQs) on Products

  1. How long has INCELL been manufacturing products and what are the company’s core areas of capability?

  2. How do I order products or inquire about products?

  3. Does INCELL have a Quality System in place?

  4. Where can I find product technical descriptions (i.e. Product data sheets, MSDS, Certificates of Analysis), and are any products in FDA Master Files?

  5. How can I receive product samples?

  6. What are the cost drivers for contract manufactured products?

  7. Can you provide information about number, size, and location of suppliers (vendors) used as sources of product raw materials?

  8. What is the production capability for specialty media or outsource manufacturing and how might other sales impact it?

  9. What are the packaging, handling, storage and transportation practices?

  10. What are the quality controls and statistical process controls?

  11. What are lead times for key components?

  12. What training is available at the site?

  13. Is there technical data package available for the products?

  14. What is the stability of the current products?

  15. Who uses the products and what types of entities are they?

  16. Are there independent test results or reviews from separate organizations?

  17. Are there minimum order quantities?

  18. What are the typical product purchasing terms?

  19. Is there a warranty?

  20. Is there customer service capability?

 

Frequently Asked Questions (FAQs) on Products

  1. How long has INCELL been manufacturing products and what are the company’s core areas of capability?

Manufactured products have been provided to the biomedical community by INCELL since 1993 in the company’s core areas of competency related to regenerative medicine, cancer, human cell biotechnology, and other fields.

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  1. How do I order products or inquire about products?

Products can be ordered online through www.incellonline.com or the button at the top of these web pages. Credit cards are accepted. They can also be purchased using a standard purchase order of your company or organization after it has been set up in the new customer database. Either call the company at 800-364-1765 or 210-877-0100 or email to info@incell.com.

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  1. Does INCELL have a Quality System in place?

Yes, INCELL has a Quality System that defines:

      • corporate commitment;

      • responsibilities;

      • quality assurance;

      • quality control;

      • safety; and

      • training components.

This is done in the context of manufacturing products, providing services, working with infectious microbes, analyzing human derived materials, doing tests in animals, and preparing for clinical applications of products and services.

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  1. Where can I find product technical descriptions (i.e. Product data sheets, MSDS, Certificates of Analysis), and are any products in FDA Master Files?

The product data and MSDS sheets can be found in the products section on-line at www.incell.com. Certificates of Analysis are provided by request to customers who purchase products. INCELL culture and cryopreservation media that are in FDA Device Master Files and FDA Drug Master Files include all of the M3™family of culture media, ACE™ media, and the cryopreservation media CPZ™ and EZ-CPZ™. A request for use of products in Master Files can be made by sending an authorized signed letter on letterhead to masterfiles@incell.com.

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  1. How can I receive product samples?

Request samples by sending an e-mail to info@incell.com and asking about a specific product. You will receive information about whether samples are available as well as specific ordering information and discounts. New customers receive a 5% discount on their first product order.

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  1. What are the cost drivers for contract manufactured products?

The cost drivers are highly dependent on the product and meeting appropriate quality standards for that product. In general, cost drivers include:

      • planning costs;

      • all aspects of time and materials costs;

      • reporting and regulatory costs/requirements;

      • equipment availability and use or preparation costs;

      • selection of technology options (e.g., disposable vs. fixed equipment asset);

      • numbers of samples to be tested;

      • method(s) to be used;

      • level(s) of training required of operator(s);

      • receipt and storage of test materials and product;

      • safety aspects of test and control components;

      • packaging, shipping, end-use of results (e.g., clinical vs. non-clinical);

      • overall costs including G&A, requirements for in-house performance only and/or interface or communications with other entities;

      • requirements for cGMP and pre-, process-and post-GMP tests;

      • requirements for cGLP and pre-, process-and post-GLP tests;

      • requirements for cGTP and pre-, process-and post-manufacturing GTP tests;

      • requirements for cGCP and pre-, process-and post-manufacturing GCP tests;

      • expected profits, discounting options or requirements; and

      • competitors’ pricing on similar products.

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  1. Can you provide information about number, size, and location of suppliers (vendors) used as sources of product raw materials?

INCELL has a large number of key suppliers, depending on the products or services requirements. All critical vendors are in the United States, and most have ready distribution to San Antonio. Some are large corporations such as national chemical and supplies vendors (e.g., Sigma or VWR). Others are smaller companies that provide components (e.g., solutions, chemicals, software) or services (e.g., testing, consulting, repairs, engineering). Vendors must meet specific selection criteria.

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  1. What is the production capability for specialty media or outsource manufacturing and how might other sales impact it?

This is highly dependent on the product or service. However, INCELL makes its best effort to begin a project within 10 business days after all contracts have been approved and signed, and all project materials and up-front payments have been received. Commercial sales are relevant only in cases where high volume sales deplete a product that may require 14-28 day testing, but maintenance of on-site stock reduces that risk.

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  1. What are the packaging, handling, storage and transportation practices?

This depends on the product, package or service and may be defined with the customer, with the following considerations:

      • standard and customized packaging options which must meet government regulations for national or international (if appropriate) transport;

      • customers pay for all shipping costs, fees, etc. unless otherwise negotiated;

      • handling, shipping, packing, storage, receiving, quarantine and release practices are defined for products, packages or materials coming into and going out of the company;

      • standards, legal requirements, and practices are adhered to for shipping human, microbiological or animal source materials;

      • staff members are trained at multiple levels to assure compliance and consistency in operations, quality and storage, as well as “chain of custody”, document handling and safety practices for receiving and sending packages;

      • outside areas of shipping containers or boxes have identifiers and labels that indicate storage conditions for the product, if appropriate, and a plastic envelope bearing the packing list is attached;

      • additional information may be included with the packing list or placed in a separate plastic envelope or sleeve inside the shipping container, depending on the requirements and components;

      • packing lists are generated through the business office and accompany shipped materials, which are tracked electronically with transporters (e.g., FEDEX, UPS) that have such systems in place and are thus the preferred vendors for the service; and

      • communications are sent by email and/or FAX to the client to indicate that a shipment has been sent and the tracking number to follow.

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  1. What are the quality controls and statistical process controls?

This is highly dependent on the product or service and may be defined with the customer. Some critical aspects are as follows:

      • product release criteria form the basis of specifications and the Certificate of Analysis for each product that is currently manufactured;

      • product manufacturing and batch record processes are in place with appropriate quality controls for testing and release post-manufacturing

      • for new client products processes, including product release criteria, are usually partially defined at the beginning of development then become more refined as the processes become known;

      • the parameters of product performance are clarified by comparative testing of replicate but separate lots of the product, to include repeat sample testing and follow-on stability testing to assess shelf life and other criteria; and

      • for services work replicate sample testing and statistical considerations are summarized and approved as part of the contract development and deliverables.

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  1. What are lead times for key components?

Most key components can be received within 2 weeks, but this depends on the type and quantity on the product or service as defined with the customer. Products are usually shipped at the beginning of the week in a customer-defined time period, with overnight or 2-day arrival most common. If the customer is providing key components, the customer will define the lead time. INCELL makes its best effort to begin a project within 10 business days after all contracts have been approved and signed and all project materials have been received.

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  1. What training is available at the site?

INCELL has an in-house training program for managers, staff and selected interns, and has provided contract-based training to others. Training elements relevant to cell, molecular, animal and clinical testing are provided, as needed, to appropriate laboratory staff, managers and administrators. Other training is focused on operational and documentation issues such as shipping and receiving, safety, GMP, GLP, GCP, GTP data management, information technology systems, equipment monitoring, communications, validation, databases, reporting, etc.

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  1. Is there technical data package available for the products?

Technical information materials on manufactured products include Information sheets, MSDS documents, and Certificates of Analysis. Kits include details on components, use and shipping.

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  1. What is the stability of the current products?

This is highly dependent on the product or service and may be defined, improved or modified with the customer. Current INCELL products have a conservative, defined shelf life indicated on their labels based on product testing showing performance beyond that time. Most media, supplements, and kit products have a 1 year shelf life post manufacturing.

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  1. Who uses the products and what types of entities are they?

INCELL’s product customer list includes scientists and product developers from government entities, large and small pharmaceutical and biotechnology companies, and academic institutions in the United States and at international sites. Kits for stem cell or cancer cell collection can be purchased by professionals or by patients and through standard or online ordering options. References on specific products and services can be requested in the context of confidentiality and with knowledge of the customer to be contacted.

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  1. Are there independent test results or reviews from separate organizations?

INCELL outsources certain types of testing to qualified vendors. References on specific types of products and services can be requested in the context of confidentiality and with knowledge of the customer to be contacted. Independent evaluators by other entities, auditors and government contract reviewers have generally reported 90% or greater overall ratings for INCELL.

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  1. Are there minimum order quantities?

Yes, but these are dependent on the product or service and the type of payment. Orders must exceed $50.00 US or $100 international for a product, excluding shipping.

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  1. What are the typical product purchasing terms?

Most products are purchased by credit card or by standard customer Purchase Orders and Net 30 days payment terms. Special orders, services and custom manufacturing generally require a 50% up-front payment with other terms negotiated depending on the scope of work through product manufacturing or project completion. Authorized signatures are required prior to the start date. Contracts may be negotiated or accepted according to various options: total funds transfer followed by deliverables, cost reimbursement, ID/IQ, standing order, monthly billings at fixed cost, credit card billings or other options.

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  1. Is there a warranty?

If customers experience a problem with a product manufactured by INCELL they can return it for an equivalent replacement product at no charge for the product or shipping. If a customer repeatedly has problems then every effort is made to troubleshoot the issue, especially when there are no other reports of problems. For distributed cell lines, there is one replacement allowed. After that, there is a replacement fee. For a new product manufactured for a customer or services provided to a customer the following language is in the contract agreement:

“INCELL makes no warranty or suitability guidelines for use of the client’s provided materials or any product that may be derived. INCELL makes no guarantee that the scientific results will specifically support or deny any hypothesis. Except as expressly set forth herein, INCELL and Client expressly disclaim any warranties or conditions, express, implied, statutory or otherwise, with respect to the test products, the current INCELL products, the current Client products, and other services and matters contemplated by this agreement, including, without limitation, the implied warranties of merchantability or fitness for a particular purpose.”

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  1. Is there customer service capability?

Yes, INCELL has on-site customer services. It uses common sense and QS components that deal with customer issues, including formalized Customer Input procedures and Corrective Action Preventive Action (CAPA) procedures. An active customer service hierarchy and capability are in place for the responding to the following issues or needs:

      • product and services orders;

      • technical support or questions;

      • communications;

      • material transfer agreements;

      • confidentiality agreements;

      • human resources and applications;

      • grants and contracts;

      • primary communications are sent by email, phone or FAX with appropriate individuals copied and archived information kept on file electronically and/or as hard copies;

      • training fundamentals for both technical and administrative staff include:

        • telephone etiquette;

        • taking messages and planning call-backs;

        • serving as a backup for answering the phone;

        • accepting orders by phone;

        • triaging calls;

        • defining operations levels of communications where they can provide expertise;

      • other aspects of attending to customer needs.

 

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