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Thanks to our more than 40 years of experience in normal human cells and best-in-class cGMP compliance, Lonza Walkersville, Inc. is the industry leader in development, manufacturing and commercialization services for cell-based therapeutics. Utilizing the expertise and protocols devised in our Process Development organization, we partner with our clients to develop client-specific, custom protocols to meet each unique need, encompassing every aspect of the business from raw material requirements to final packaging and distribution. Open, consistent communications during the manufacturing process ensure optimal results and customer satisfaction.
We have extensive experience acquiring tissues for FDA-approved therapeutics. Our staff ranges from the lead scientist who serves on the Standards Committee of the American Association of Tissue Banks (AATB), to physicians with in-depth expertise in donor testing and eligibility criteria and specialists who handle logistics, control, and documentation. Lonza will:
- Help clients comply with current donor eligibility criteria by developing the informed consent and health questionnaire specific to the tissue needed
- Develop client-specific programs for acquiring tissues, including acquisition process flow that suits the donor and tissue specifications
- Train tissue coordinators at participating sites
- Oversee donor selection and screening and the tissue acquisition process
- Determine final donor eligibility
Lonza works with Organ and Tissue Procurement Organizations, hospitals and private physicians in the U.S. to collect tissues within the framework of the AATB standards and FDA regulations for manufacturing processes for clinical use. Lonza is also registered with the FDA as a tissue bank. Tell us what you need and we will employ our established, quality processes to obtain it for you.
Our state-of-the-art cGMP manufacturing facilities, located in the U.S. and in Europe, enable us to provide all the support services you might need to produce human cells for therapeutic use, including:
- autologous cells of varying shelf life for shipment to the US and Europe;
- allogeneic cells, including sourcing, production of cell banks, and expansion to product quantities;
- stem cell production via both master and feeder cell-banks.
We are equipped for and have experience with flasks, roller bottles, beads and cell factories, including tissue engineered formats to meet specific customer requirements.
Our U.S.-based suites currently comply with ISO Class 7 (Class 10,000) classification to meet U.S. requirements, and we will soon offer suites with ISO Class 5 (Class B) compliance for European needs. Our European suites meet all current European GMP regulatory standards. From the unidirectional flow design for materials and personnel to the equipment we utilize, the suites are engineered with exceptional quality in mind. Flexibility in design permits us to configure the suites to meet unique customer needs and optimize productivity. Each suite boasts a dedicated air-handling system, as well as a separate air-handling system for common areas, thus preventing cross-contamination. Additionally, every suite features its own dedicated cleaning and environmental monitoring equipment, as well as alarmed backup equipment.
We are exceptionally cognizant of the need to segregate projects, and are fastidious about protecting your product, as well as your process. At the conclusion of each project, validated changeover and cleaning procedures are implemented, culminating in the Quality Assurance organization releasing the suite for use for each individual project. All of this translates to ensuring the integrity of your product and consistently meeting customer expectations with efficient systems and high quality results.
We can help you throughout all stages of your product's life cycle, assist you in jump-starting clinical trials with cGMP-manufactured product, or provide commercial-scale production. We've been around the block, so we know what challenges lie along the path to commercialization. Talk to us about how we can help you successfully commercialize your product. |
Lonza works with Organ and Tissue Procurement Organizations, hospitals and private physicians in the U.S. to collect tissues within the framework of the AATB standards and FDA regulations for manufacturing processes for clinical use. Lonza is also registered with the FDA as a tissue bank. Tell us what you need and we will employ our established, quality processes to obtain it for you.
Our state-of-the-art cGMP manufacturing facilities, located in the U.S. and in Europe, enable us to provide all the support services you might need to produce human cells for therapeutic use, including: |
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