Presentation On:

Designing of Drug Delivery System

for Biotechnology Products
Considering Stability Aspects and
Monitoring Methods of Improving
Stability.
 Group No.: 08

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

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.
 Biotechnology:

Any technological application

uses biological system to
produces modified product.

Example:
•Recombinant DNA
• Stem cell therapy
•Cloning.
 Biotechnology
Product:

Product which are manufactured by

Modified Genetic Materials of living
cell at molecular level.

Example:
• Antibiotics
• Vaccines
• Genetically Modified
Organism(GMO)
• Insulin
Routes of Drug Delivery

Oral

Transdermal
Routes of Nasal
Drug
Delivery

Parentaral Rectal

Buccal
 Designing of Drug
Delivery System for
Biotechnology Products:

1. Gene Therapy.

2. Encapsulation Methods.

3. Protein and Peptide Technology.

4. Recombinant DNA Technology.

5. Monoclonal Antibodies.
 Gene Therapy:

A technique to deliver DNA

or RNA molecules to cells/
tissues for the treatment of
genetic disease.

Cloning Loading the Vector Delivering the

Identification identical Genetic material
vector with reaches therapeutic gene
of affected healthy integrated into
therapeutic the target into the nucleus of
gene. DNA & performs.
gene. gene. cell. the target cell
Mechanism of
Gene Therapy:
 Viral Methods:
Including adenovirus,
retrovirus, lentivirus,
adenoassociated virus,
herpes simplex virus.

Viral
Viral Expansion Purification Polishing Fill-finish
amplification
 Non-viral vectors are
molecules of circular
DNA.

Non-Viral Methods:
Physical Mechanical Chemical &
methods: methods: synthetic
Laser irradiation, Necked DNA methods:
electroporation, injection, Liposomes,
magnetoporation, microinjection, gene polymers, inorganic
ultrasound. gun. nanoparticles.
 Microencapsulation
products do not interfere
with other ingredients.

Increased self-life
and consumers are Microencapsulati Sensory properties
able to taste the on: remain unaltered.
added capsule.

Microencapsulated
ingredients can be added at
any time in the processing
and remain unaltered.
Nanotechnology:
 Protein and
Peptide
Technology:

Vaccine Hormone
Recombinant
Technology:

Humuline.

Recombinant
Alteplase (Activase).

Lepirudine
(Refludan). Figure: Recombinant Technology
1. Immunization of mice &

Monoclonal
isolation of splenocytes.

2. Preparation of myeloma cell. Antibody:

3. Fusion.

4. Clone screening & picking.

5. Functional characterization

6. Scale up & wean.

7. Expansion.
Stability Parameters:

Light

Humidity

Temperature

Environment Condition
Chemical Stability:

Deamidation

Proteins
Racemization Proteolysis
&
Peptides
Reaction:
Disulfide
Exchange Oxidation
 Storage Conditions:

Container

Labeling

Shelf-Lives of
Biotech
Products Bioreactor
Improving Stability:

PEGlylation

Empirical
Stochastic Rational
Approach
Design
 Improving Stability:

Improving the safety and

efficiency of many
therapeutic
macromolecules such as
Protein and Peptides

Example:
Pegademase Bovine
Pegaspapargase
Pigvisomart etc.

PEGylation
 Improving Stability:

Stochastic • Developed to produce

enzymes with improved
laboratory functional properties
techniques including stability.

• Sequence and structure

analysis.
Empirical • Example: Design Protein,
rational design Unveiling Protein Folding.
 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.
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.