Cord Blood Banking Services: CellSafe

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OPERATIONAL PLAN

  1. Services and Products

Cord Blood Banking Services

CellSafe offers a chance to the parents to protect their baby’s health by storing the cord blood with us. We realise the importance of cord blood for future medical use especially to treat blood-based illness such as blood cancer and anaemia. Our services will include procurement, testing, processing, and storage of the cord blood. We aware about the customer concern on the safety of the cord blood. Therefore, we guarantee that every procedure will take place in sterile condition, carried out by trained personnel and using the latest technologies such as the cryopreservation system with robotic function. This is the updated technology with good system integrity that can ease the storage, protection and retrieval of the units.

Products

CellSafe will sell three high-quality products to research institutes; fresh, unprocessed cord blood, CD34+ cell and differentiated cord blood cells. To avoid any ethical and legal issues, we will get parent’s consent to turn 20% of the cord blood cells collected into research products.

  1. CD34+ cell

CD34+ is a glycoprotein and found as hematopoietic stem cells (Civin et al., 1984). It can be further differentiated into more committed blood cells and endothelial lineages (Asahara et al., 1997). We will isolate the CD34+ population from cord blood using positive immunomagnetic method. CellSafe will provide CD34+ cell derived from cord blood of single or mixed samples. We only release the final product which contains 100,000 cells and a purity of more than 90%. The price of CD34+ cell offer by CellSafe is also much cheaper in comparison with our competitors.

  1. Fresh, undifferentiated cord blood cell

Cord blood is rich in stem cells and has been used to treat more than 80 diseases (Moise K., 2005). With the aim to support cellular therapies and transplantation, CellSafe will sell the fresh, undifferentiated cord blood cell at reasonable price. The freshly obtained cord blood offers a high rate of stem cell viability in comparison with the frozen ones (Beshlawy A.E. et al., 2009). We can prepare this product from single or mixed samples, with a volume containing 500,000 cells. Universities may ask for specific product characteristics depending on their research projects. Thus, we will try our best to meet their needs.

  1. Differentiated cord blood (neural stem cell)

Neural stem cells (NSC) have been greatly exploited for neurodegenerative and neuromuscular studies. Human fetal tissue is one of the sources of pluripotent stem cells that can differentiate into NSC (Vogel G., 2000). However, the use of fetal tissue for research is always associated with ethical issues. CellSafe would like to promote other alternative by turning the cord blood cells into neuron-like ones using a differentiation medium. The Quality Control Department will ensure that the production process is carry out based on the proper medical practice.

  1. Scope of Operation

CellSafe will follow the standard protocol mapped out by Human Tissue Authority (HTA) in United Kingdom. The scope of operation will cover:

  1. Access to cord blood cells

The CellSafe liaison officer will contact the corporate vice president of NHS clinics and The British Pregnancy Advisory Service main office to reach potential customers in a more personal way. Our target is to collect 13,244 samples each year.

  1. Parent’s guide and consent

We encourage the customer to consult with their obstetrics and gynaecology (OB/GYN) first and contact CellSafe for registration before her 34th week of pregnancy. We will then contact the OB/GYN to inform him or her about the customer’s decision. We will try to get the enrolment form, medical record and written informed consent from at least one parent (preferably both parents) or a legal guardian prior to the onset of labour.

  1. Procurement of cord blood

CellSafe’s team will collect a blood sample from the mother before labour. The cord blood collection will take place after the placenta is delivered, ideally after clamping the umbilical cord. Next, the obstetrician will place the placenta in a sterile container and pass it to our trained personnel. They will bring it to the collection area aseptically, wash and disinfect the umbilical cord with 70% alcohol and iodine swab. 21 G needle will be used to puncture the cord and enter the umbilical vein. The cord blood will be placed in a 200 mL sterile bag (MSC1206DU, Macopharma) containing 21 mL anticoagulant solution. We need to collect at least 50mL and maximum 200 mL of cord blood. The cord blood will be stored at 4oC until processing (Hubel et al., 2003).

  1. Transportation and Testing

Our team will load the samples into the refrigerated truck. It is equipped with a temperature monitoring device to deliver safely the content into the processing site. In the BioPark, the next procedure will take place within 48 hours after the collection to preserve the stem cell viability (Parents Guide to Cord Blood, 2007). As the samples reach the Processing Centre, our technicians will enter the new units into the database.

A small aliquot (450-500 µL) will be used for a number of tests such as the total nucleated cells (TNC) count, CD34+ cell count and viability, blood testing, Cytomegalovirus (CMV) test and test for infectious and inherited diseases. The mother’s blood sample will be tested promptly for HIV, HTLV-I/II, anti- HCV, hepatitis B surface antigen, CMV infection and syphilis.

  1. Processing

80% of the cord blood will be transferred from the collection bag into sterile, disposable processing bag sets using a sterile-docking device. AXP® (AutoXpress) processing platform will centrifuge the unit twice. The first centrifugation will separate the blood components from the plasma. While the second spin will stratify the blood components into three different AXP bag set: red blood cell (RBC) bag, freezing bag (stem-rich buffy coat component) and plasma bag. The removal of RBC and plasma is necessary to get a uniform volume (20mL) and consistent freezing conditions for all units. Besides, the RBC may compromise the buffy coat as it can burst during thawing (National Cord Blood Program, 2004). Another 20% will be processed and sold to the Higher Education Institute (HEI).

  1. Freezing

The freezing process must happen slowly to avoid cell damage. Dimethylsulfoxide (DMSO, 5 mL of a 50% solution), will be used as a cryoprotectant to avoid membrane rupture. The freezing bag will be carefully transferred from room temperature to storage temperature using an automated controlled rate freezer. Once they reach the appropriate temperature, the units will be stored in BioArchive® Cryopreservation System.

  1. Storage

BioArchive® Cryopreservation System is a storage container with liquid nitrogen that keeps samples at a constant temperature of -196oC. This advanced freezer can store over 3,600 blood bags. It is equipped with a robotic arm that aids in the retrieval of a particular unit without disturbing the others, thus avoid temperature fluctuation. Within two weeks, parents will get a certificate of ownership and the test results.

Figure 1: Workflow diagram of cord blood banking. A) 200 mL sterile bag will be used to collect cord blood. B) After testing, the cord blood will be transferred into AXP ® Processing System. Centrifugation of cord blood will give three components; (i) red blood cells, (ii) buffy coat and (iii) plasma. C) This unit will be placed into metal cartridge and ready for freezing stage. D) After frozen, the unit will be transferred into a permanent storage system.

  1. Supplying

From 20% of the cord blood collected, 5% will be sold as fresh unprocessed cord blood based on the order that is placed a week before cord blood collection. Temperature monitoring data tracking will be provided to maintain the temperature during delivery. Our staff will reduce the volume of another 15% of cord blood and store the unit. Once the order is placed, the robotic arm of BioArchive® cryogenic storage will select the cord blood unit and guide it through a slow thaw process. After thawing, our supplying team will prepare the mononuclear cell suspension and isolate the CD34 cells using CD34+ isolation kit (Figure 2).

Figure 2: Isolation of CD34 cell through positive selection using EasySepTM isolation kit (Stem Cell Technologies, 2014).

If there is order for NSC product, our staff will isolate the mesenchymal stem cell from cord blood (Figure 3). Then, they will use the differentiation medium to induce direct differentiation of cord blood-mesencymal stem cell into NSC.

Figure 3: Mesenchymal stem cell isolation from cord blood (Irvine Scientific, 2015)

  1. Regulation

The collection and storage of cord blood cells in the United Kingdom are subjected to strict regulation enforced by HTA under Human Tissue Act 2004. Parents can only store the cord blood in the licensed facilities that accredited by HTA. The duration of the license is three years with fee of £4,650.00. Every cord blood bank must follow the guidance document issued by HTA on 29 November 2010 to minimize the risk faced by the mother and the babies. To achieve the quality standards and maintain the company longevity, CellSafe will ensure that the cord blood samples meet the criteria stated by HTA. We will try to get the accreditation from Medicines and Healthcare Products Regulatory Agency (MHRA) for our laboratories by fulfilling the minimum standard of ISO 9001 with good laboratory and manufacturing practices. CellSafe is confident that by following the HTA regulation, we can give the best service to our potential customers and clients. CellSafe will refer any legal issue to Bonnacord.

  1. Quality control

High-quality products and great services is our top priority. Therefore, CellSafe will establish a Quality Control Department to monitor the safety and regulatory issue in all areas of operation.

Table 3: The important aspect that require thorough quality control

Personnel

  • CellSafe will only hire qualified staff.
  • All staff needs to undergo training programme based on HTA training policies and procedures.
  • Training provided will be vary depends on the role of staff in the CellSafe.

Materials and facilities

  • The materials should follow the specifications and requirements to manufacture desired products.
  • The specifications and standards have been set down by HTA Directions 003/ 2010 and UK Guidelines.

Cord blood collection

  • The collection bag must have FDA approval and CE mark that meet the requirement of Medical Devices Directive.
  • To minimize the contamination risk, only one bag will be assembled at a time.
  • Samples must be correctly labelled and the label number for each collection bag should be recorded.
  • The collection bag must be transferred within 48 hours to the processing centre to maintain the temperature.

Processing and storage

  • To prevent mix-up, only one set of cord blood samples will be processed at a time.
  • It is important to always monitor the temperature of storage system. A backup system should be prepared for unexpected mechanical failure.

Supplying

  • Assigned staff will verify every order and record the supplying item.
  • A team will do final inspection and ensure that the products meet the customer’s specification.

Data protection

  • All computers are protected by password to protect the files and only authorized personnel can have an access to the confidential records.
  • We will prepare backup files in hardcopies and softcopies form.

Complaint and feedback

  • Customers can give complaints and feedbacks regarding our services, staffs or products.
  • All complaints will be recorded for corrective action.
  1. Memberships and Affiliation

Memberships

Cord Blood Europe

Consist of European private organisations that active in the cord blood banking industry. By becoming member of Cord Blood Europe, CellSafe can get consultation about the regulation of cord blood banking and seek an opportunity to widen our network.

British Association for Tissue Banking

The Association is developed to open the opportunity for discussion about tissue banking. CellSafe can get information from other members about the tissue banking practices.

Affiliation

Parent’s Guide to Cord Blood Foundation

The first aim of this foundation is to educate parents about the benefits of cord blood in regenerative medicines. It also trying to expand the use of cord blood for research. This is a good platform to convince parents about our service.

University partnership

CellSafe plan to make partnership with five universities which are University College London (UCL), University of Oxford, University of Cambridge, Imperial College London (ICL) and King’s College London. We will supply the processed and unprocessed cord blood to these institutes for 5 years.

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