Single Use packaging
Bioprocessing
Biopharm market
Containment 1
Containment 2
Lucky Dip - a Wylie
100
Primary function of a single-use powder transfer bag
- To transfer liquid formulations
- to transfer powders in a contained manner
- to hydrate bulk powders, in the bag, before dispense
to transfer powder in a contained manner
100
Which step(s) in bioprocess manufacturing should we target for single use powder bags?
- Buffer prep
- Media prep
- Final fill
- Cell culture feeds
- All of the above
All of the above
100
Upstream Improvements is a Biopharmaceutical market driver. True or False - this leads to the following;
- higher product titres
- smaller operating footprints
- increase in the use of single use technologies
True
100
Customer wants to complete a powder transfer within an explosive atmosphere with a UV sensitive product - what transfer method do you propose?
- P2 ChargeBottle
- ChargeBag
- PuroVaso OW (Translucent)
- PuroVaso CB
- PuroVaso CB
100
What are acceptable methods of sterilisation for a ChargeBag with SUP?
- Gamma Sterilisation
- Autoclave out of Place
- VHP Decontamination
- Steam in Place
- Gamma Sterilisation
100
Who crossed first?
John
200
What would you recommend the following bag be used for?
Buffer and Media preparation - large volume
200
Which part of the bioprocess might you find these?
Which target application is associated with the step
Downstream processing - chromatography steps
Buffer preparation
200
Which modality has the following definition?
....... are derived from a single source or clone of cells that recognize only one type of antigen. They are used for various therapeutic process is including treating cancers autoimmune diseases and infections.
- vaccines
- recombinant proteins
- monoclonal antibodies
Monoclonal antibodies
200
Can you name the following valve?
PharmaSafe Pro
200
Can you name the valve shown below?
AseptiSafe Bio
200
What sport is this - if you can call it a sport!
Tag rugby
300
What is a key advantage of using single use bags over stainless steel containers?
- reusable and durable
- more resistant to high temperatures
- eliminate the need for cleaning and sterilization
They eliminate the need for cleaning and sterilization
300
Why is bioreactor size and titre important (maybe more than one correct answer)
- it isn't really important
- Helps determine opportunity size
- titre tells us process concentration
- They are common terms used in API manufacture
Helps determine opportunity size
- titre tells us process concentration
300
What is a characteristic of a small molecule pharmaceutical
- they are chemically synthesized
- they are derived from living organisms
- they are chemically synthesized
300
An Active, which will be directly exposed to pressure can be docked via which of the following methods;
- Docked via an Assisted Manual Raise Lower
- Manually docked in place
- Docked via a PowerDock
- Docked via a Lifter and in-process Compensator
- Manually docked in place
300
What is the purpose of the external seal on a Single Use Passive?
- To allow for a 6BarG pressure rating
- To allow for Steaming in Place
- To allow for VHP decontamination of the disc faces
- To centralise the valve during docking
- To allow for VHP decontamination of the disc faces
300
How many hearts does the following have?
Three
400
What is a common application for single use powder bags in the biopharmaceutical industry?
- Transferring raw materials, like API's
- transfer of small volume cell culture media feeds
- transfer of bulk powdered buffer chemicals
- all of the above
all of the above
400
A bioreactor of 2000L, in a process with a 5g/L titre, produces how much drug per run?
- 10g
- 10Kg
- 1000g
- 10Kg
400
Which biopharmaceutical modality involves the use of monoclonal antibodies?
- Gene Therapy
- Cell therapy
- Protein therapeutics
- RNA therapeutics
- Protein therapeutics
400
Which of the following statements is true?
- A 100mm Active half is capable of holding 10BarG when coupled with a PR Plug.
- A 200mm Active valve half is capable of holding 6BarG when uncoupled and fitted with a PR Plug.
- A 150mm Non-PR Passive valve half, when coupled to an Active valve can be exposed to pressure within the system.
- A 250mm DL Active valve can be exposed to a low level 500mBar pressure.
- A 100mm Active half is capable of holding 10BarG when coupled with a PR Plug.
400
Which of the following statements is incorrect?
- For high-level containment we would recommend the use of a PharmaSafe pro valve with extraction.
- For high-level containment we would recommend the use of a bio valve with VHP decontamination.
- For high-level containment we would recommend that the transfer of product is followed by a liquid flush through prior to uncoupling.
- For high-level containment we would recommend that the transfer off an Isolator is completed with use of a dispensing funnel.
- For high-level containment we would recommend the use of a bio valve with VHP decontamination.
400
When was this founded?
1997
2001
2009
2015
1997
1000
Thinking about upstream and downstream processing, which has the higher rate of single use adoption, and what is the % adoption (within 10-15%)?
DSP
77%
1000
What are the keywords in this statement that indicate an opportunity for us;
- R&D and manufacturing - scale up
- bioreactors
- cell culture based vaccines
1000
Which companies are the odd ones out in the groups below?
Genmab
Pfizer
Galderma
1000
Who is this - and why is he known in South Wales
John Toshack (Liverpool and Swansea)