FPS Flashcards
What is the benefit of Continuous Manufacturing?
More efficient
Safer, due to no manual handing
Smaller equipment and facilities
Smaller ecological footprint
Lower costs
What are the 3 levels of State Control Requirements for Continous Manufacturing?
Level 1 –> Active control systems with real-time monitoring of quality attributes (Flexible CPPs to allow for variability in CMAs)
Level 2 –> Reduced end product testing and operation within established ranges and confirmed with final tests
Level 3 –> Inability to test for quality without end product testing. Not very flexible
Why is Hybrid Continous Manufacturing done?
As the API needs to be made via batch manufacturing as they’re made in free trade zones (to avoid tax)
Once the API is in the country/factory, then the rest of the process is done via continous manufacture
Explain what Portable Continuous, Miniature and Modular (PCMM) Manufacturing is….and the benefits that it brings
A modular factory with standardized ‘plug and play’ equipment
This allows a rapid changeover of drug production (different drugs), flexbile batch sides and production-on-demand
Also give more real-time monitoring with multiple analysers incorprated
Fully automated
What are the main benefits of having a greater Sigma Process in manufacturing?
Less defects (ppm), greater yields and decreased cost for quality!
The Pharmaceutcial world are currently operating at 2-3 Sigma….what does this mean?
Treating symptoms and not the route cause (of quality)
Measurments that are done are done because they can be….not because they should be (meaning that some measurments just aren’t done)
Lack of understanding as to why things are done…but just acceptance that they are
What is Quality by Design?
Aligned with Kaizen principles
Aim is to create products with quality built into them by planning, and not by chance –> If this is done then end-product testing isn’t needed as we know that it is of quality
Enables continuous improvement
What are the benefits of QbD?
Reduces development time
Minimises product cost
Useful when troubleshooting
More efficinent timing of product releases
Allows maintainence of the product life cycle with greater ease
What is the The Quality Triology?
Quality Planning –> Plan and define the quality requirements of the end product
Quality Control –> Variability in product and proccesses need to controlled by scientific tools and risk-based statistical tools for monitoring end-product quality
Quality Improvement –> A contiunous process throughout the drugs lifecycle by regulating controls
What are the 5 steps of implementing QbD?
Define the Quality Target Product Profile (QTPP) –> Planning quality before production has even started
Identifiy the Critical Quality Attributes (CQAs) –> The key quality attributes for the drug
There are final and intermediate CQAs
Identify the Critical Material Attributes (CMAs) and Critical Processing Parameters (CPPs) –> These are vital in ensuring that the CQAs are met
Design Space Development –> Explores the relationship between material/process inputs and CQAs
Allows manufacturers to prove to authorities that they understand their process
Quality Control and Continous Improvement –> These control can include in-process measurments and end-product testing
What is Olaparib?
And what are the major issues with it?
A PARP inhibitor (inhibiting cell repair) for those with BRCA1/2 mutations
Issues –> Solubility and permability
Led to it having to be formulated as a Hot-Melt Extrusion (HME) tablet
What are the 4 reasons for poor asthma control in general?
Therapy resistent disease
Social Factors –> Environment
Behavioural Factors –> Adherence and inhaler technique
Psychological Factors –> Anxiety and depression
What 3 things do people with asthma need in order to increase adherence?
To realize the neccesity of the medication
To negotiate their concerns about treatment
Support for the emotional aspects of their disease
What is disruption?
A radical change in industry or a business strategy
Eg, 3D printing
Why is the rate of synthesis of monoamines relatively slow?
As after entering the synaptic cleft they can be reuptaken into the neurone
So they are reused!
What is the transporter that allows dopamine to be reuptaken into the neurone, and also has an allosteric binding site that cocaine can bind to?
Dopamine Reuptake Transporter (DAT)
Also could be how amphetamines are released into the synaptic cleft
How do monoamine releasing agents actually decrease the amount of monoamine that is reuptaken?
Via competitive inhibiton!
They are uptaken instead of monoamines, meaning that naturally less monoamines can be reuptaken
Explain the process of CAR T therapy
T cells are removed from the patient via leukapheresis
They are then genetically altered by adding the Chimeric Antigen Receptor (CAR) to their surface, which contains CD3 and CD28 (and other co-stimulatory signals)…..this enables the cells to target the specific cancer cells and kill them
These recombinant cells are then cultured in the lab until there are billions, before being injected back into the patient for treatment
