Helixate® FS

(Antihemphilic Factor)

Md. Nazrul Islam

Roll: 1280
 Objective

• To manufacture & sell antihemophilic factor

in Bangladesh.
 Hemophilia??
• Haemophilia is a mostly inherited genetic disorder
that impairs the body's ability to make blood clots.

• This results in people bleeding longer after an

injury, easy bruising, and an increased risk of
bleeding inside joints or the brain.

• 13 coagulation factors are involved in blood clot

formation ranging from factor-I to factor-XIII.
 Types of Hemophila
• There are two main types of haemophilia:
1. haemophilia A, occurs due to not enough clotting
factor VIII, &
2. haemophilia B, occurs due to not enough clotting
factor IX.

• Haemophilia A affects about 01 in 5,000–10,000 males at

birth.

• According to WFH, 10000 people are affected in hemophilia

in Bangladesh
 Antihemophilic Factor
• also known as Factor VIII (FVIII)
• A 300KD heterodimeric glycoprotein that is produced
naturally in the body.
• helps blood to form clots to stop bleeding.
• Encoded by F8 gene
• Produced in Liver & secreted
in plasma
• Undergoes posttranslational
modification.
 Types of FVIII
• Mainly of Two Types. Namely
1. Antihemophilic factor human
2. Antihemophilic factor, human recombinant

• This product is available in the powder form (for

Solution)

• Though FVIII can be produced both from blood

plasma and mammalian cell culture using rDNA
technology, the latter technology is superior.
 Production Process of rFVIII
Production Process of rFVIII
• Two types of rFVIII are being produced. Such as-
1. rFVIII (with albumin) and
2. sucrose-formulated rFVIII (rFVIII-FS)
• The trade name of the latter is Helixate FS
• A continuous perfusion fermentation system rather
than batch is being used to produce BHK-derived
rFVIII.
Production Process of rFVIII
 Affinity Purification

• Small peptides such as

1. Trp-His Tyr-Tyr-His-Gly (WHYYHG),
2. His-Ile-Gln-His-Tyr-His (HIQHYH), and
3. His-Gln-Tyr-Gly-Tyr-His (HQYGYH)

can be used to purify rFVIII Bead

• Three types of buffer will be used in this

affinity purification step.
Affinity Purification
Affinity Purification
Global FVIII Market Size
 Market Size in Bangladesh
• According to World Federation of Hemophilia
(WFH), more than 10,000 people in Bangladesh are
affected in Hemophilia.
• Most of them are hemophilia A affected.
• Population number is also increasing day by day.
• Available treatment:
1. Anti Hemophilic Factor (Factor VIII) Injection (10,000TK)
2. Cryoprecipitate
3. FFP (Fresh Frozen Plasma) (4,000-6,000TK)
4. Fresh Blood
 SWOT Analysis
STRENGTH OPPORTUNITIES

•Treatment of choice •Lack of effective medication in the

•Offer higher purity and safety market
•No side effects & less complication •Number of diseased population is
•Most effective treatment than rising day by day
cryoprecipitate and fresh frozen
plasma (FFP)

WEAKNESS THREATS
•Because it is a new product some
•Expensive
lack of knowledge may lead to
•frequent intravenous injection
rejection
•putative demand of product cannot
•Appearance of competitors in a
be determined
short time
 Summary

1. Hemophilia with its types

2. Antihemophilic factor
3. Production and Purification
4. Global & local Market Size
5. SWOT analysis
 Summary
1. https://patents.google.com/patent/US5994310A/en?oq=US5994310
2. https://www.nature.com/articles/nrd.2018.54
3. https://www.ncbi.nlm.nih.gov/pubmed/12098089
4. https://www.ncbi.nlm.nih.gov/pubmed/27841041
5. https://en.wikipedia.org/wiki/Haemophilia
6. https://www.mayoclinic.org/drugs-supplements/antihemophilic-factor-intravenous-
route/description/drg-20068497
7. https://en.m.wikipedia.org/wiki/Factor_VIII
8. https://www.prothomalo.com/bangladesh/article/1552461/%E0%A6%B9%E0%A6%BF%E0
%A6%AE%E0%A6%BE%E0%A6%95%E0%A7%87-
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%E0%A6%A6%E0%A6%BF%E0%A6%A8
9. https://boishakhionline.com/18651/%E0%A6%A6%E0%A7%87%E0%A6%B6%E0%A7%87-
%E0%A6%B9%E0%A6%BF%E0%A6%AE%E0%A7%8B%E0%A6%AB%E0%A6%BF%E0%A6%B2
%E0%A6%BF%E0%A7%9F%E0%A6%BE-
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%E0%A6%B9%E0%A6%BE%E0%A6%9C%E0%A6%BE%E0%A6%B0
10. https://www.banglanews24.com/health/news/bd/443565.details
Let’s make a change..