Questions and Answers
Cell therapy can be classified as ______ or allogeneic.
autologous
Fresh frozen plasma (FFP) must be used within ______ hours if thawed and stored at 4ºC.
24
Platelets have a shelf life of ______ days from donation.
5
Storage of blood products can be built into the ______ site.
Signup and view all the answers
The ______ method determines the transportation of cell therapy products.
Signup and view all the answers
Red blood cells (RBCs) have a shelf life of up to ______ days when refrigerated.
Signup and view all the answers
Short-shelf life of products impacts the business model's ability to carry out ______.
Signup and view all the answers
Contamination risks can include leaky bags/vials and ______ nitrogen.
Signup and view all the answers
The challenge of transport is understanding the impact on the product, including ______ and shelf life.
Signup and view all the answers
To preserve cells over the medium to long-term, methods such as cryopreservation and ______ are utilized.
Signup and view all the answers
During transport, changes in ______ can affect the viability of the cells.
Signup and view all the answers
An ideal preservation method should be widely applicable and maintain the cells’ key ______.
Signup and view all the answers
Specialized clinics may focus on 'cell ______' or disease-specific therapies.
Signup and view all the answers
A significant challenge in the clinic is matching the availability of ______, surgeon, and patient.
Signup and view all the answers
Hypothermia is a short-term preservation strategy for certain types of mammalian cells and ______.
Signup and view all the answers
When considering transportation, using dry ice and dry shippers can be ______ and laborious to prepare.
Signup and view all the answers
GMP compatibility is essential in ensuring that the preservation method is suitable for ______ use.
Signup and view all the answers
Cell recovery after preservation requires minimal ______ in order to ensure high viability.
Signup and view all the answers
The process of ______ is known for removing moisture by sublimation of ice into water vapour.
Signup and view all the answers
The use of ______, such as trehalose, is required during the lyophilisation process.
Signup and view all the answers
Hypothermia is a preservation method based on cold storage of organs, where cells are preserved at temperatures greater than ______ºC.
Signup and view all the answers
Cells can proliferate during mild hypothermia, typically maintained between ______ and 33ºC.
Signup and view all the answers
Desiccation methods enable transport at ambient temperatures, impacting the ______ of cell preservation.
Signup and view all the answers
The process of uncoupling cell-culture from cell-based assays/QC testing enables transport at ______ temperatures.
Signup and view all the answers
In cell harvesting, a media change with ______ is required before processing the cells.
Signup and view all the answers
Cryopreservation involves a slow freeze rate of ______ per minute.
Signup and view all the answers
Cells can be harvested from various types including hepatocytes, MSCs, and ______ cells.
Signup and view all the answers
Cell pausing can occur at ______ or 4°C.
Signup and view all the answers
The processing centre performs characterisation and quality tests along with safety and ______ tests.
Signup and view all the answers
Transport to the medical site is typically done at ______ temperatures.
Signup and view all the answers
Cryopreservation is the most widely used method of cell __________.
Signup and view all the answers
Cells harvested are processed to ensure they meet ______ standards.
Signup and view all the answers
Hypothermic storage is becoming widely used for cell __________.
Signup and view all the answers
Liquid nitrogen is used for cell preservation, particularly in the vapor phase at ______.
Signup and view all the answers
Transportation and storage challenges often require innovative ______ methods.
Signup and view all the answers
Desiccation provides an alternative long-term storage solution but is in its __________.
Signup and view all the answers
Recovery can be variable, despite the use of specialized __________.
Signup and view all the answers
The impact of __________ on cell function is a concern in hypothermic storage.
Signup and view all the answers
Lack of research into the __________ process poses challenges in cell preservation.
Signup and view all the answers
Iron chelators and apoptosis inhibitors are examples of other components tested for cell __________.
Signup and view all the answers
The ability to preserve cells in __________ is crucial yet lacks widespread reporting.
Signup and view all the answers
Variable results in the literature indicate challenges in maintaining cell __________.
Signup and view all the answers
Understanding the impact of storage and __________ is essential for cell therapies.
Signup and view all the answers
Study Notes
Transport and Banking of Blood Products
- Consistent starting materials in banking reduce the need for continuous culture, saving costs and time, while minimizing contamination risks.
- Blood products include different types of components, each with unique storage requirements:
-
Red Blood Cells (RBCs):
- Refrigerated with a shelf life of up to 42 days.
- Stocks maintained in hospitals to balance supply and minimize wastage; infusion must occur within 30 minutes of removal from fridge.
-
Fresh Frozen Plasma (FFP):
- Stored frozen, needs onsite defrosting.
- Must be used within 24 hours if thawed and stored at 4ºC.
-
Platelets:
- Shelf life of about 5 days; usually closer to 3 days.
- Requires requests from hospitals and is stored at blood banks.
-
Red Blood Cells (RBCs):
Factors Influencing Cell Therapy
- Types of cell therapy include autologous and allogeneic methods which require consideration of scale.
- Business model decisions involve single or multi-site manufacturing, and on or off-site production.
- Preservation methods influence transportation logistics, flexibility of the system, and onsite processing capabilities.
Challenges in Storage and Transport
- Storage can be a challenge due to short shelf life affecting business models and quality control efforts.
- Contamination risks include issues related to liquid nitrogen and leaks in storage containers.
- Transport challenges focus on ensuring product viability:
- Requires both refrigerated and frozen transport (e.g., dry ice).
- Important factors include delays, vibrations, and temperature fluctuations impacting product integrity.
On-Site Processing and Investment Needs
- On-site processing decisions encompass thawing, washing, and recovery periods, which affect cell viability and function.
- Significant investments required for equipment and training of healthcare staff, especially in specialized clinics.
- Preservation methods like cryopreservation, desiccation, and hypothermia play roles in medium to long-term storage solutions for different cell types.
Ideal Preservation Methods
- Preservation methods sought should be broadly applicable and maintain key characteristics of cells or organisms.
- Must comply with Good Manufacturing Practices (GMP) and withstand fluctuations in storage conditions.
- Cell recovery should require minimal manipulation, and methods should be cost-effective including storage and shipping considerations.
Specialized Media in Hypothermic Storage
- Recovery of cells in hypothermic conditions can vary based on the medium used; clinical trials produce mixed results.
- Example: Hepatocytes maintained in specialized media (e.g., HypoThermosol-FRS) show around 70% viability but decreased metabolic function compared to fresh isolates.
Emerging Alternatives in Preservation
- Cryopreservation remains the most common method for cell preservation, with increasing use of hypothermic storage.
- Desiccation, particularly lyophilisation, allows for longer-term storage at ambient temperatures but is still in early development.
- Concerns exist regarding the impact of desiccation on cell function and the need for extensive studies on variability in storage conditions.
Future Directions and Research Needs
- Knowledge of product handling and preservation methods must be enhanced to improve efficiency and outcomes in cell therapies.
- Development of processes that decouple cell culture from testing may facilitate transport and handling of products at ambient temperatures.
- Ongoing evaluation of various cell types for preservation effectiveness is crucial to advancing methodologies in the field.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
This quiz covers essential information on the banking and transport of blood products, including Red Blood Cells, Fresh Frozen Plasma, and Platelets. Understand their storage requirements, shelf life, and the importance of consistent starting materials in maintaining quality. Test your knowledge on factors influencing cell therapy and related business models.
