Learn about what are biopharmaceutical molecules, antibodies as an example, their manufacturer and production details.

1. By
ManishaThakur

2. Biopharmaceuticals
 Biopharmaceuticals are medical drugs produced using biotechnology.
 These also referred as “Biological Products” or “ Biologics” contain an
active substance derived from or extracted from a biological system.
 They are often administered as an injection or infusion.
 The first such substance approved for therapeutic use was
recombinant human insulin.
 A potentially controversial method of producing biopharmaceuticals
involves transgenic organisms, particularly plants and animals that
have been genetically modified to produce drugs.

3. Examples of Biopharmaceuticals
 Hormones
 Growth factors
 Antibodies
 DNA and RNA
 Enzymes
 Blood protein
 Clotting factors
 Stem cells

4. Monoclonal Antibodies
 These are identical immunoglobins, generated from a single B-cell
clone.
 They recognize unique epitopes or binding sites on a single antigen.
 Some myeloma cells synthesize single monoclonal antibodies
naturally.
 In 1986, first monoclonal antibody, Orthoclone OKT3 was licensed by
FDA.

5. HUMIRA/ADALIMUMAB
 Adalimumab is a fully human monoclonal antibody targeted toward tumor
necrosis factor alpha (TNF-alpha).
 The brand name Humira stands for “HUman Monoclonal
antibody In Rheumatoid Arthritis",
 It was named by one of Abbott's employees, Richard J. Karwoski, who was
also responsible for leading the effort to get Humira FDA approved.
History
 It was the first fully human monoclonal antibody approved by the U.S. Food
and Drug Administration.
 It was discovered as a result of a collaboration between BASF Bioresearch
Corporation and Cambridge Antibody Technology U.K. , which began in 1993.
 Initially named D2E7.

6. What is the most important information you should know about
HUMIRA?
HUMIRA is a TNF blocker medicine that can lower the ability of your immune
system to fight infections.
 Serious infections : tuberculosis (TB) and infections
 Cancer : For children and adults taking TNF blockers, including HUMIRA, the
chance of getting lymphoma or other cancers may increase.
Biological function
 Directly binds to TNF-alpha molecule in blood and diseased tissue.
 Block its interaction with the p55 and p75 cell surface TNF receptors.
 Stops the inflammatory cycle of psoriatic disease and prevent from causing
inflammation that result in psoriasis plaques.

7. Applications
HUMIRA is a prescription medicine used to reduce the signs and
symptoms of
 Rheumatoid Arthritis (RA)
 Polyarticular Juvenile idiopathic Arthritis (JIA) .
 Psoriatic Arthritis (PsA)
 Ankylosing Spondylitis (AS)
 Crohn's disease (CD)
 Hidradenitis suppurativa (HS)
 Ulcerative colitis (UC)
 Plaque psoriasis (Ps)
 To treat non-infectious intermediate (middle part of the
eye), posterior (back of the eye), and panuveitis (all parts of the
eye) (UV)

8. Production
 The production process of adalimumab is complex and it is based in the
called phague display technology.
 Phage display technology allows the isolation of human antibodies
against almost any antigen through the clonal selection of antibody
fragments in a prokaryotic system, thus facilitating both
immunotherapy and in vivo diagnosis.
Manufacturer
 Abbott Laboratories' new Barceloneta, Puerto Rico, manufacturing facility
will be the primary production facility for the TNF inhibitor Humira
On January 1, 2013, Abbott split into two companies, one retaining the Abbott
name and the other named AbbVie.
 As a result, AbbVie took over development and marketing of Humira

9. Abbott Laboratories
 It is an American health care company
 Headquarters : Lake Bluff, Illinois, United States.
 Founded : 1888 (as Abbott Alkaloidal Company)
 Founder : Dr. Wallace Calvin Abbott
 Revenue : US$ 27billion (2017)
 It split off the research-based pharmaceuticals into AbbVie in 2013.
 Products : Branded generic drugs
Medical devices
Diagnostic assays
Dietary supplements

10. Trastuzumab (Herceptin)
 Trastuzumab is a targeted cancer drug also known by its brand name,
Herceptin.
 It is a treatment for cancers that have large amounts of a protein
called human epidermal growth factor receptor 2 (HER2).
 Source : Humanized (from mouse)
 Target : HER2/neu
 It may be used by itself or together with other chemotherapy medication.
Trastuzumab is given by slow injection into a vein and injection just under the
skin.

11. History
The drug was first discovered by scientists including Dr. Axel Ullrich and
Dr. H. Michael Shepard at Genentech, Inc. in South San Francisco, CA.
Adverse effect : Cardiac toxicity, birth control.
Applications
 Trastuzumab is used to treat metastatic (spread) breast cancer.
 It is effective against tumors that overexpress the HER2/neu protein.
 As part of chemotherapy regimen for adjuvant treatment of lymph-node
positive, HER2/neu protein positive breast cancer.
 Treatment of gastric (stomach) cancer.

12.  Genentech, Inc., is a biotechnology corporation which became
a subsidiary of Roche in 2009.
 Type : Wholly owned subsidiary of Roche
 Industry : Biotechnology
 Founded : 1976
 Headquarters : South San Francisco, California, United States
 Products: Avastin
Herceptin
Rituxan
Perjeta
Kadcyla
Gazyva
Genentech Biotechnology