BIOTECHNOLOGICAL ASPECT

OF PRODUCT DEVELOPMENT.
CONCEPTS AND TECHNIQUES
GROUP 1;
• AYESHA IMRAN
• RANA MUHAMMAD AWAIS
• AHSIN IQBAL
• SYEDA GULL-E-FATIMA
 INTRODUCTION TO
BIOTECHNOLOGY, BIOLOGICS
AND BIOPHARMACEUTICALS

CONTENTS INTRODUCTION TO THE

CONCEPT OF BIOSIMILARS

ROUTE OF ADMINISTRATION
OF BIOLOGICS
INTRODUCTION TO BIOTECHNOLOGY,
BIOLOGICS AND BIOPHARMACEUTICALS

BIOTECHNOLOGY
• It is defined as ‘the manipulation of biological organisms to make products benefiting
human beings.
BIOLOGICS AND BIOPHARMACEUTICALS
• A biopharmaceutical (biological or biologic), which consists of sugars, proteins, nucleic
acids, living cells or tissues, is a medicinal product manufactured in extracted or semi-
synthesized from biological sources like humans, animals, or microorganisms. Transgenic
organisms, especially plants, animals or microorganisms that have been genetically
modified, are potentially used to produce biopharmaceuticals.
BIOLOGICS AND
BIOPHARMACEUTICALS
Major sources of biopharmaceuticals
 BIOSIMILAR

A biosimilar, also known as ‘follow-on biologic’, is a biologic

medical product that is almost identical to a copy of an original
product manufactured by different pharmaceutical companies.
BIOLOGICS AND
It is highly similar to a licensed reference product in spite of
BIOPHARMACEUTIC minor differences in clinically inactive components.
ALS
There are no clinically significant differences between the
biosimilars and the reference products in terms of safety, purity
and potency.

Biosimilars can be manufactured when the original innovator

product’s patent expires, and are officially approved versions of
the original products.
COMPARISON BETWEEN GENERIC DRUG AND BIOSIMILAR
 Unlike conventional small molecule drugs, biological drugs
may exhibit lower stability and a greater sensitivity to
enzymatic degradation, making oral delivery problematic.
Hence, the majority of biologics are currently administered
through subcutaneous (SC), intramuscular (IM) injection or
via intravenous (IV) infusion.
ROUTES OF IV ROUTE
ADMINISTRATI • Intravenous delivery has traditionally been the standard
ON OF route of administration for biologic drugs such as antibody
BIOLOGICS or recombinant protein therapies.
• IV delivery of biologics provides the principal advantages
of
(1) achieving 100% initial bioavailability with no loss of drug
at the point of entry into the body and
(2) the immediate dissemination of the drug through the
systemic circulation, rapidly accessing all vascularized
tissues throughout the body.
 Clinically Approved Biologics for Intravenous
Delivery
• Monoclonal antibodies (mAbs) comprise the
majority of the biologic drugs currently approved
ROUTES OF for IV administration.
ADMINISTRATI • These include basiliximab, daclizumab,
ON OF infliximab, and a large number of other mAbs
that have been developed predominantly for the
BIOLOGICS purpose of cancer therapy
Limitations of Intravenous Delivery of Biologics
• One of the primary limitations of IV delivery: the
potentially toxic side effects in nontarget organs
that can be subjected to high levels of
intravenously administered biologic drugs.
 SUBCUTANEOUS ROUTE
• IV infusion is accompanied by the risk of catheter-
mediated infection, causes significant pain and
discomfort, and requires supervised inpatient
administration. For more patient-friendly administration
ROUTES OF and to enable self administration, SC delivery of biologics
ADMINISTRATI is of great interest.
ON OF • Another context in which the use of SC injection is able to
BIOLOGICALS improve on IV delivery is in the case of biologic drugs
with severe toxicity after systemic infusion.
Clinically Approved Biologics for Subcutaneous Injection
• For biologic drugs that have short half-lives in vivo, the
availability of a formulation for self administered SC
injection provides an obvious benefit to patient quality of
life.
 ROUTES OF ADMINISTRATION OF
BIOLOGICS
• For example, Anakinra therapy of rheumatoid arthritis requires a daily injection of 100mg per
dose. Similarly, a number of TNF-a antagonists have been developed and licensed for self-
administered SC injection in the treatment of rheumatoid arthritis.
• Although SC injections can be used to achieve a flatter pharmacokinetic profile (a lower peak
plasma concentration but a more prolonged duration at an efficacious level),
• Limitation
• a limitation of the SC route is the injection volume that can be administered without pain in
humans, at a maximum of approximately 2 to 2.5ml of fluid.
ORAL ROUTE
• Particle Carriers for the oral Delivery of Biologics; Microparticle and nanoparticle carriers have
been investigated extensively for the encapsulation and oral delivery of proteins for the dual
purposes of protecting their cargo from the degradative environment of the GI tract as well as
enhancing uptake across the intestinal epithelium.
ROUTES OF ADMINISTRATION OF
BIOLOGICS
• Co-delivery of Modulatory Agents to Improve Absorption from the
Gastrointestinal Tract
A second general strategy for improving the oral delivery of biologics
involves the co-administration of modulatory compounds aimed at either
directly enhancing uptake into epithelial cells, increasing the permeability of
the epithelial layer (to allow paracellular absorption), or inhibiting
proteolytic activity in the GI tract. Using a diverse array of agents such as
cell-penetrating peptides, detergent-like molecules, or mucoadhesive
polymers, these effects have been demonstrated in both in vitro models of
epithelial cell layers and in vivo animal models.
References
Routes of Delivery for Biological Drug Products, DARRELL J.
IRVINE, XINGFANG SU, and BRANDON KWONG

Skalko-Basnet N. (2014). Biologics: the role of delivery

systems in improved therapy. Biologics : targets &
therapy, 8, 107–114. https://doi.org/10.2147/BTT.S38387