General Information

Description of Capabilities

INCELL is dedicated to bringing client-customized quality services to biomedical applications. On-time and on-budget are important to the contract services process. INCELL has capabilities in the following areas of expertise for contracts in product development and testing at the molecular, cellular, animal (pre-clinical) and clinical development levels. Release testing and characterization for potency and efficacy of new biological molecules are commonly done. INCELL is NOT a Contract Research Organization for managing or performing clinical trials. The company has in-house capabilities, an extensive network of Subject Matter Experts and consultants, collaborators, and Consultant Scientists.

Personalized Medicine: Next Big Hope or Next Big Hype? http://www.pharmamanufacturing.com/articles/2005

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 Contract Services

1. How long has INCELL been providing contract services and what are the company’s core areas of capability?

2. How do I start the inquiry process for client customized services?

3. Does INCELL have a Quality System in place?

4. What are the cost drivers for contract services?

5. How does INCELL implement its “Best Commercial Practices” for services?

6. Can you provide information about number, size, and location of suppliers (vendors)?

7. What is the production capability to meet requirements and how may commercial sales affect them?

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

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

10. What are lead times for key components?

11. What training is available at the site?

12. Is there technical data package availability?

13. What is the stability of the current configuration/technology?

14. Who uses INCELL services and what types of entities are they?

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

16. Who owns the intellectual property from a services agreement or contract?

17. What are the typical service contract terms?

18. Is there a warranty?

19. Is there customer service capability?

Frequently Asked Questions (FAQs) on Contract Services

1. How long has INCELL been providing contract services and what are the company’s core areas of capability?
   

Contract services 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 as described above.

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2. How do I start the inquiry process for client customized services?
   

Either call the company at 800-364-1765 or 210-877-0100 or email to info@incell.com.

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3. 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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4. What are the cost drivers for contract services?
   

The cost drivers are highly dependent on the service and meeting appropriate quality standards for that service based on the “client customized” need. 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., develop new test vs. use of a COTS test or kit);

• 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 current Good Manufacturing Practices (cGMP) and pre-, process-and post-GMP tests;

• requirements for current Good Laboratory Practices (cGLP) and pre-, process-and post-GLP tests;

• requirements for current Good Tissue Practices (cGTP) and pre-, process-and post-manufacturing GTP tests;

• requirements for current Good Clinical Practices (cGCP) and pre-, process-and post-manufacturing GCP tests;

• expected profits, discounting options or requirements; and

• competitors’ pricing on similar services.

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5. How does INCELL implement its “Best Commercial Practices” for services?
   

INCELL implements its “Best Commercial Practices” across many aspects of its business, with regard to the needs of the company and in making decisions important to the customer. A brief summary of key elements is as follows:

1. Requirements: Business case and project-driven requirements are based on:

   • strategic planning;

   • trained and qualified staff;

   • market analysis;

   • financial considerations;

   • life-cycle analysis;

   • availability of existing (e.g., Commercial Off The Shelf [COTS]) products and expertise;

   • vendor sources;

   • supportive documentation; and

   • needs for additional tools or expertise.

2. Vendor Selection: The overall goal in vendor selection is to use “Best-value” procurement techniques to obtain a quality product, process or service that meets the need at the most reasonable price. The approach and considerations are as follows:

   • do online research relevant to subject matter;

   • solicit multiple, qualified vendors for pricing and specified criteria;

   • cost criteria include: unit cost, discounts, lot size, preferred rates and shipping costs;

   • prior (long-term) relationship history and experience with vendor;

   • (heavily weighted) past performance from personal experience and trusted references;

   • review and evaluate supportive documents; and

   • make site visits to vendor, if appropriate
     

3. Development: Project needs drive development, are defined by dialog with the customer and, depend on multiple factors:

   • prototype and end-use;

   • formal and informal communications between individuals or teams;

   • project or product complexity;

   • industry standards and requirements;

   • specific or unique uses and level of flexibility;

   • defined milestones;

   • prototyping and clarification of final requirements;

   • proposed timelines and deliverables;

   • operational in-house testing or beta testing may be used;

   • management oversight and risk assessment commensurate with program complexity.
     

4. Business and Operations: Established relationships and associated oversight are key components to business and operations components which include:

   • formal and informal collaborations, contracting, and partnerships with mutual economic benefit, and a vested interest in joint “win-win” success;

   • integrated systems and collaborators-partners for products and services related to research, development, manufacturing, testing, packaging and delivery;

   • formal written agreements and contracts to assure integrity and clarity of understandings between parties, associated requirements and expectations, change orders framework, and payment terms;

   • vendors, managers and staff are sought for long-term relationships, but can be hired and fired at will;

   • multi-component maintenance operations include on-site and outsourced options after cost and risk evaluation;

   • projects are usually done by selected teams of managers, staff and subject matter experts with defined schedules and deliverables; and

   • projects or programs may be short-term or require multi-year funding.

5. Intellectual Property (IP): The status of project IP depends on the relationship and contracts according to the following general guidelines:

   • in-house development of IP by staff for INCELL is owned by INCELL;

   • IP development is managed by INCELL as part of weekly reporting system

   • custom project performance or development that results in IP for a client is generally owned by the client, with some exceptions –such as existing proprietary material or shared IP;

   • collaborative projects generally have shared IP and agreements in place to protect discovery; and

   • terms are noted in the individual contracts, from employees to business relationships.

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6. Can you provide information about number, size, and location of suppliers (vendors)?
   

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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7. What is the production capability to meet requirements and how may commercial sales affect them?
   

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 after 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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8. 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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9. 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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10. 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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11. 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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12. Is there technical data package availability?
    

There is technical information on products but most services work is client-customized so there is not a universal “data package” available.

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13. What is the stability of the current configuration/technology?
    

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.

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14. Who uses INCELL services and what types of entities are they?
    

INCELL’s 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 for use of the cells in cancer testing or for cryopreservation of adult stem cells or other applications. References on specific services can be requested in the context of confidentiality with INCELL.

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15. 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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16. Who owns the intellectual property from a services agreement or contract?
    

In a fee-for- service contract the intellectual property is wholly owned by the customer. In a collaborative agreement for product development, manufacturing or other services, where INCELL brings its unique intellectual property or capabilities to a project, then the intellectual property is usually shared.

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17. What are the typical service contract terms?
    

Most services are purchased by a standard customer Purchase Orders and Net 30 days payment terms. Services, special orders, 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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18. Is there a warranty?
    

If customers experience a problem with a service or deliverables provided by INCELL there are terms of responsibility for INCELL and the customer. With regard to a warranty, INCELL service agreements have the following language 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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19. 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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