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Printable Handouts
Navigable Slide Index
- Introduction
- New processes for new vaccines
- Old technology: NOT how to make new products
- Best available technology: Making new products
- Manufacturing facilities: Basic considerations
- Manufacturing facility: Separate air systems
- Raw material testing (Dr. Jekyll and Mr. Hyde)
- How are vaccine products made?
- Bulk antigen production
- How do we make vaccine products? (1)
- The vaccine vial
- Sterile filling of vaccines
- Label requirements
- Packaging requirements
- What vaccine regulations do we need to follow? (1)
- What vaccine regulations do we need to follow? (2)
- What vaccine regulations do we need to follow? (3)
- The mechanism for regulatory compliance
- Standard elements of quality systems
- Raw materials & manufacturing process control
- Documentation control
- Quality system: Responses to unexpected events
- Quality system dynamics
- SOP revision cycle
- Product is vaccine AND Information
- How do we make vaccine products? (2)
- Warehousing of vaccine product
- Example: vaccine warehouse configuration
- Cold chain distribution
- Vaccine delivery to customers and patients? (1)
- Vaccine delivery to customers and patients? (2)
- Summary
Topics Covered
- New vaccines & the need for up-to-date technology
- Considerations for manufacturing facilities
- Quality systems (The mechanism for regulatory compliance)
- Large scale, routine manufacturing
- Warehousing and distribution of vaccine product
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Gerson, D. (2023, June 12). Vaccine manufacturing 2 [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 24, 2024, from https://doi.org/10.69645/WLKG3273.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Don Gerson has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Vaccine manufacturing 2
Other Talks in the Series: Vaccines
Transcript
Please wait while the transcript is being prepared...
0:04
Is another kind of topic
that has caused
vaccine manufacturers
and other biopharmaceutical
manufacturers
a great deal of difficult. Over, say,
the last 30 or 40 years, especially
in vaccine business
since it first got
born as a major worldwide
activity, a lot of things
have changed.
We have enormously better
scientific understanding.
We know about the pathogen. We
know about protective epitopes.
We know exquisitely about
molecular biology and immunology.
We know huge amounts about
bio-chemical engineering.
And if we put all this
knowledge together,
we can apply it to
make new vaccines,
and we can do it
fearlessly, and with success
because we know what we're doing.
On the other hand, there's a
strong tendency in the industry
to retain traditional
methods of manufacturing
thinking that like making wine
some characteristic of the vaccine
is imparted by the tradition and is
beyond the scope of modern science.
1:13
And so even fairly
recently developed
vaccines, as you can see in the
next slide use eggs for instance.
And fertilized egg is a nice
source of dividing chicken cells.
They are susceptible
to growing viruses,
and the egg looks like a very
nice container that probably
is kind of sterile on the inside.
The reality is it isn't
quite sterile on the inside.
You can't define where it came from.
You can't really sterilize
it on the outside.
So it's always got some amount
of microbial contamination.
And you have no idea what's going
on inside, so you can't control it.
So to make a brand new manufacturing
process that's based on fertilized
eggs is in the same
category as making
a brand new electronic device
that's based on using vacuum tubes.
And vacuum tubes have some
utility in the universe today,
but if you're making a piece
of electronic equipment,
practically no one would go and
use an electron vacuum tube such as
the one on the right in this slide.
So you have to think
about this carefully.
We want to use today's
best available technology
to make today's best vaccines.
And the way you do that
is in the next slide.