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1. How many suites are available?
At Lonza Bioscience, there are currently eight suites at the Walkersville facility including a suite with EU Class B certification. Our Verviers, Belgium facility has four suites.
2. What type of cells have you worked with?
Fibroblasts, keratinocytes, renal cells, umbilical cord cells, vascular endothelial cells, dendritic cells, myoblasts and mesenchymal stem cells are among the cell types with which we¡¦ve worked.
3. How are technicians qualified?
Qualification of a client's process is accomplished through Aseptic Process Validations (APVs). APVs simulate the client¡¦s process (with growth medium) and challenge the technician¡¦s aseptic technique. Successful completion of the APV with no bacterial or fungal contamination qualifies the technician to perform the client¡¦s process.
4. What other support functions are offered for Cell Therapy Manufacturing?
Tissue Acquisition, Process Development, including scale-up, assay development, equipment and process validation, materials and supplies sourcing, plus product storage and distribution are routinely part of our offering. We would be pleased to consider specific requests from customers.
5. What product storage options are available?
Available storage options include LN2 Liquid, LN2 Vapor, -80 °C, -70 °C, -20 °C, 2-8 °C, plus ambient and incubated temperatures.
6. What is involved with technical transfer of a manufacturing process?
The Tech Transfer process includes incorporating records (Master Batch Records, Standard Operating Procedures, Quality Control/Assurance procedures, Materials Requirements) into Lonza Bioscience¡¦s, validated Electronic Document Management System, Material Sourcing, equipment and process qualification, Technician Training, Aseptic Process Validations, Engineering runs, Validation/Consistency Runs.
7. What is the typical technical transfer time after a manufacturing contract has been signed?
The average technical transfer time is approximately three months, but can vary greatly depending upon the complexity of the project.
8. What product testing options are available?
Lonza Bioscience offers a comprehensive menu of testing services for assays including molecular biology, microbiology, virology, cell biology, sterility, endotoxin, mycoplasma and bioanalytical services.
9. What are Cell Therapy Manufacturing¡¦s hours of operations?
Cell Therapy is currently operating on 2 shifts, approximately 16 hours per day.
Click here to view a printer-friendly version of Cell Therapy FAQs.
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