"Where there is life, there is DNA, where there is DNA, there is biotechnology." Biotechnology, as the word suggests, is combination of biology and technology. So the importance of biotechnology and biotechnology products in our life is increasing day by day. That's why we have to produce biotechnology products in a safer manner and also maintain that through it's shelf-life.We have also research on improving methods of improving it's stability. In this topic, I also tried to discuss bioinformatic-driven strategies that are used to predict structural changes that can be applied to wild type proteins in order to produce more stable variants. The most commonly employed techniques PEGylation, stochastic approaches, empirical or systematic rational design strategies.

1. Presentation On:
Designing of Drug Delivery System
for Biotechnology Products
Considering Stability Aspects and
Monitoring Methods of Improving
Stability.

2. Name: Reg. No.:
1. Laboni Das Prome 15103056
2. Hazeratull Jannat 15103071
3. MD. Shahadat Hossain 15103082
4. Smaranika Rahman 15103092
5. Zobaida Mostarin 15103094
Group No.: 08

3. Contents:
• What is biotechnology and biotechnology products?
• Routes of drug delivery.
• Designing of drug delivery system for biotechnology products.
• Stability parameters.
• Methods of improving stability.

4. Any technological application
uses biological system to
produces modified product.
Example:
•Recombinant DNA
• Stem cell therapy
•Cloning.
Biotechnology:

5. Product which are manufactured by
Modified Genetic Materials of living
cell at molecular level.
Example:
• Antibiotics
• Vaccines
• Genetically Modified
Organism(GMO)
• Insulin
Biotechnology
Product:

6. Nasal
Rectal
Oral
Transdermal
Parentaral
Buccal
Routes of
Drug
Delivery
Routes of Drug Delivery

7. Designing of Drug
Delivery System for
Biotechnology Products:
Gene Therapy.
Monoclonal Antibodies.
Protein and Peptide Technology.
Encapsulation Methods.2.
3.
4.
5.
Recombinant DNA Technology.
1.

8. A technique to deliver DNA
or RNA molecules to cells/
tissues for the treatment of
genetic disease.
Gene Therapy:
Identification
of affected
gene.
Cloning
identical
healthy
gene.
Loading the
vector with
therapeutic
gene.
Vector
reaches
the target
cell.
Delivering the
therapeutic gene
into the nucleus of
the target cell
Genetic material
integrated into
DNA & performs.

9. Mechanism of
Gene Therapy:

10. Viral
amplification
Viral Expansion Purification Polishing Fill-finish
Viral Methods:
Including adenovirus,
retrovirus, lentivirus,
adenoassociated virus,
herpes simplex virus.

11. Non-viral vectors are
molecules of circular
DNA.
Non-Viral Methods:
Physical
methods:
Laser irradiation,
electroporation,
magnetoporation,
ultrasound.
Mechanical
methods:
Necked DNA
injection,
microinjection, gene
gun.
Chemical &
synthetic
methods:
Liposomes,
polymers, inorganic
nanoparticles.

12. Microencapsulati
on:
Microencapsulation
products do not interfere
with other ingredients.
Microencapsulated
ingredients can be added at
any time in the processing
and remain unaltered.
Sensory properties
remain unaltered.
Increased self-life
and consumers are
able to taste the
added capsule.

13. Nanotechnology:

14. Protein and
Peptide
Technology:
Vaccine Hormone

15. Recombinant
Technology:
Humuline.
Recombinant
Alteplase (Activase).
Lepirudine
(Refludan). Figure: Recombinant Technology

16. Monoclonal
Antibody:
1. Immunization of mice &
isolation of splenocytes.
2. Preparation of myeloma cell.
3. Fusion.
4. Clone screening & picking.
5. Functional characterization
6. Scale up & wean.
7. Expansion.

17. Light
Humidity
Temperature
Stability Parameters:
Environment Condition

18. Proteins
&
Peptides
Reaction:
Deamidation
Proteolysis
Oxidation
Disulfide
Exchange
Racemization
Chemical Stability:

19. Storage Conditions:
Bioreactor
Container
Labeling
Shelf-Lives of
Biotech
Products

20. Improving Stability:
PEGlylation
Empirical
Rational
Design
Stochastic
Approach

21. Improving Stability:
PEGylation
Improving the safety and
efficiency of many
therapeutic
macromolecules such as
Protein and Peptides
Example:
Pegademase Bovine
Pegaspapargase
Pigvisomart etc.

22. Improving Stability:
• Developed to produce
enzymes with improved
functional properties
including stability.
Stochastic
laboratory
techniques
• Sequence and structure
analysis.
• Example: Design Protein,
Unveiling Protein Folding.
Empirical
rational design

23. Conclusion:
By overcoming the current
obstacles, including government
regulations, financial support, and
large-scale production and
manufacturing will lead us to a day
where all biotechnology products
are delivered in a targeted and safer
manner.

24. References:
Ansel, H.C., Allen, L.V., Popovich, N.G. Products of Biotechnology. In: Troy, B.D., Hauber, M.J. editors. Pharmaceutical
Dosage Forms and Drug Delivery Systems. Baltimore: Lippincott Williams and Wiikins; 2005: 600-651.
Orive, G., Ndez, R.M.H., Gasco, A.R.G., Gily, A.D.N., Perdraz, J.L. Drug Delivery in Biotechnology: Present and Future.
Current Opinion in Biotechnology, 2003, 14; 659–664.
Rafe, M.R., Ahmed, Z. Liposomal Drug Delivery Systems Have Opened a New Window in Pharmaceutical Sciences: A
Literature-based Review. Asian Journal of Pharmaceutics, 2017: 11(4); 250-254.
Saini, R., Saini, S., Sugandha, R. S. Biotechnology: The Novel Drug Delivery System. International Journal of Nutrition,
Pharmacology, Neurological Diseases, 2011: 1(1); 82-83.
Suplatov, D., Voevodin, V., Svedas, V. Robust enzyme design: Bioinformatic tools for improved protein stability.
Biotechnology Journal, 2015: 10(3); 344-355.