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Yashraj Biotechnology Ltd Volume 6, Issue 3, September 2019 www.yashraj.com
INSIDE THIS ISSUE High Pure Native Antigens
High Pure Recombinant
Antigens
Stem Cell and Preclinical Drug
Discovery
Welcome Aboard:President
(R&D)
Glimpses of AACC, USA-2019
Upcoming Meet-MEDICA 2019
ADVISORY BOARD Shri. Arvind K. Bhanushali
Shri. Bharat T. Dagha
Dr. G. Padmanaban
Dr. Paresh Bhanushali
EDITORIAL BOARD Chief Editor
Dr. Chander P. Puri
MEMBERS Dr. Shweta Bhatt
Dr. Gauri Awasthi
Dr. Anuj Kumar Gupta
Dr. Kunal Shukla
Dr. Mukesh Mani Tripathi
Mrs. Prerana Rathod
Mr. Nikhil Rautela
Dr Anjali Karande
Yashraj Biotechnology Ltd. (YBL) has earned itself a prestigious place as one
of the top 10 biotechnology companies in 2019, in India, as per Silicon India.
The company has created a mark as a research and innovation driven
biotechnology company, manufacturing a wide range of high pure
biomarkers from Native, Recombinant and Cell-derived sources as well as
monoclonal antibodies.
These remarkable accomplishments are a testimony to YBL’s commitment for
quality and innovation which underscores its robust quality and safety
management systems that have ISO 13485:2016, ISO 9001:2015 and OHSAS
18001:2007 certifications and its steep growth and global presence across
several continents (Europe, USA, Asia).
Over fifty high pure antigens have been developed that are used as controls,
calibrators, immunogens and bio-markers for infectious diseases, cancers,
cardiac, renal, liver, neurological and autoimmune disorders. Inflammation
marker CRP, cancer markers such as CA15-3, CA125, CA19-9, CA72-4, and
markers for HBV infection such as HBsAg-Ad and HBsAg-Ay are amongst the
flag-ship products of YBL that have captured global markets over the years.
In this issue we bring some of our immunogen grade (CIE cleared) Native
antigens - Azurocidin, PSA, RBP, Ferritin and B2M and some of Recombinant
antigens – rSLO, rProlactin, rCRP, rSHBG and rHIV-1 p24 .
The strength and uniqueness of YBL’s scientific activities for the
manufacturing of biomarkers lies in its recombinant DNA technology and
mammalian cell culture division that largely complement and provide an
alternate route of development of its unique native products derived from
biomedical fluids.
YBL has also expanded its presence in the biotechnology sector by venturing
into drug discovery, screening and toxicology space. The stem cell program
has received accolades and endorsement from the Technology Development
Board, Ministry of Science and Technology, India. YBL has developed many
unique products and services to aid in the pharmaceutical drug discovery
research.
1
Yashraj Biotechnology Limited.
C-232, TTC Industrial Area, MIDC,
Navi Mumbai- 400705, India.
Website: www.yashraj.com
Email: [email protected]
Telephone: +91 22 62166800
YBL NEWSLETTER Volume 6, Issue 3, September 2019
Yashraj Biotechnology Limited Has Been Chosen as One of the 10 Most
Pro isi g Biotech ology Co pa ies 9
Azurocidin is a ~29 KDa protein also known as cationic antimicrobial or
heparin-binding protein (HBP). It is an inactive homolog of serine proteinases
(Pseudoenzyme) residing in azurophilic granules of human Poly-
Morphonuclear Neutrophils (PMN). It is a promising biomarker for
identification of patients who are at risk of developing sepsis with circulatory
collapse, hypotension, and organ failure. YBL manufactures high
immunogenic grade Azurocidin stable for more than 1 year at 2-8°C.
High Pure Native Antigens
Prostate-specific antigen (PSA) is a ~29 KDa glycoprotein produced by
normal, as well as malignant cells of the prostate gland. It is a serine
protease enzyme, the level of which increase in prostate cancer. Due to
continuous demand of the PSA in the market, YBL has developed high pure
immunogenic grade PSA with real time stability of 2 years at -20°C.
AZUROCIDIN
PROSTATE-SPECIFIC ANTIGEN
RETINOL BINDING PROTEIN
Retinol-binding protein (RBP) is a ~21 KDa lipocalin which serves as a retinol
transport vehicle in serum. As it plays a crucial role in overall development of
an embryo, it is used as a biomarker for early embryo mortality or
developmental malformations. RBP is one of the emerging biomarkers in
diagnostic world and to cater to the growing demand, YBL has developed
high pure immunogenic grade RBP stable at 4°C for 1.5 years.
Ferritin is a ~450 KDa intracellular protein complex that consists of 24 protein
subunits. These subunits store iron and in humans they act as a buffer against
iron deficiency and iron overload. Serum ferritin levels are measured in
medical laboratories as part of the iron studies workup for iron-deficiency
anemia. The ferritin levels measured usually have a direct correlation with
the total amount of iron stored in the body. At YBL, we manufacture high
pure immunogenic grade Ferritin that is stable for 3 years at 2-8°C.
FERRITIN
BETA-2-MICROGLOBULIN
Beta-2-microglobulin is a ~12-kDa globular protein recognized as the light-
chain component of the MHC-I molecule and is a biomarker for monitoring
the progression of renal disease to chronic renal failure. It is one of the
trusted biomarker in medical world and YBL manufactures high pure
immunogenic grade B2M with real time stability of 3 years at 2-8°C.
SDS PAGE of Azurocidin (~29 KDa)
SDS PAGE of PSA (~29 KDa)
SDS PAGE of RBP (~21 KDa)
SDS PAGE of Ferritin (~450 KDa)
SDS PAGE of B2M (~12 KDa)
2
KDa
66
43
29
21
14
B2M ~12 KDa 6
www.yashraj.com Volume 6, Issue 3, September 2019
STREPTOLYSIN O (SLO) Streptolysin O is a 69 KDa toxic enzyme produced by group A Streptococcus bacteria. YBL
supplies different forms of Recombinant Streptolysin O i.e. 1) Recombinant Streptolysin
O: This preparation has high enzymatic (hemolytic) activity (> 150000 HU/ml). 2)
Recombinant & Stabilized Streptolysin O (Glutaraldehyde stabilized); 3) Recombinant
& Stabilized Streptolysin O (Glutaraldehyde stabilized contains free amino group): This
preparation has recombinant purified Streptolysin O protein, stabilized with
Glutaraldehyde and blocked with an amino group containing compound. So it has free
amino group for coupling reaction with latex particle. Antigenic activity of all 3 products
is determined by Turbilatex indirect method. Source: Transformed E.coli, Acc# Q8P2T7,
Mol. Weight: ~66.4 kDa (FrSLO-29).
PROLACTIN Prolactin (PRL) is a 23 KDa is a peptide hormone produced by the pituitary gland
and various extra pituitary sites. PRL has been shown to be associated with the
modulation of a variety of actions in the immune and inflammatory processes in
several pathological conditions. Concentration of purified recombinant Prolactin
protein is determined by CLIA (Bayer Centaur). Source: Transformed E. coli BL21
(DE3) ply.S, Acc# Q5THQ0, Mol. Weight: ~23 kDa (without tag).
SEX HORMONE BINDING GLOBULIN (SHBG)
SHBG, is a 47 KDa glycoprotein that binds to estrogens and androgens. Decreased
concentrations of SHBG in women have been associated with hyperandrogenism
and endometrial cancer due to heightened exposure to androgens and estrogens,
respectively. Recombinant SHBG is high pure and the concentration of purified
protein is determined by CLIA (Roche). Source: Mammalian Cells, Acc# P04278,
Mol. Weight: ~47 kDa (without tag)
C-REACTIVE PROTEIN (CRP)
C-reactive protein (CRP) a 25 KDa is well known inflammation marker.
Immunoturbidimetry, ELISA, Nephelometry and Rapid Immunodiffusion are
common methods to determine CRP concentration. Recombinant CRP is high pure
and concentration of purified active CRP is determined by Immunoturbidimetry
(Spinreact). Source: Mammalian Cells, Acc# P02741, Mol. Weight: ~25 kDa
(without tag)
HUMAN IMMUNODEFICIENCY VIRUS -1 p24
Early detection is crucial in HIV diagnosis. HIV-1 P24 antigen appears in the
blood as early as 14 days after probable infection. Concentration of purified
protein is determined by ECLIA (Roche). Product is high pure with high
antigenicity as per Abbott (CMIA), Biomerieux VIDAS (ELFA) and Ortho (ECLIA)
assays. Source: Transformed E. coli, Acc# P12497, Mol. Weight: ~26 kDa
(without tag).
SDS PAGE of rSLO (~66.4 KDa)
SDS PAGE of Prolactin (~23 KDa)
SDS PAGE of SHBG (~47 KDa)
SDS PAGE of rCRP (~25 KDa)
SDS PAGE of HIV1 p24 (~26 KDa)
High Pure Recombinant Antigens
3 www.yashraj.com Volume 6, Issue 3, September 2019
Stem Cell and Preclinical Drug Discovery:
New Products and Services
We have ventured into preclinical drug discovery space using unique technology of induced pluripotent stem cells
(iPSCs) that received a Nobel Prize in Medicine in 2012. This technology opened up a plethora of possibilities for
clinical discovery in the oncology space. Our core research objectives in the stem cell program are, 1) Bio-banking
of human clinical samples, 2) Use of iPSCs and it derivatives for Drug Discovery and Disease Modeling, 3) Use of
iPSC Derived Differentiated Lineages such as Cardiomyocytes and Hepatocytes for Drug Toxicology, and 4)
Regenerative Medicine and Therapy.
Our stem cell program has developed various primary cancer cell and stem cell derived platforms from human
subjects (healthy volunteers and/or patients with cancer originating in different tissues), for use in preclinical drug
discovery, screening and toxicology.
Well characterized products being developed and likely to be made commercially available soon are:
1. Primary human cancer epithelial cells (e.g. from patients with Breast Cancer, Ovarian Cancer, Prostate
Cancer etc.) useful for preclinical drug (efficacy testing) discovery research.
2. Primary human PBMCs (Peripheral Blood Mononuclear Cells) for research and development.
3. Human induced pluripotent stem cells from healthy subjects, breast cancer patients, ovarian cancer
patients etc. for clinical discovery.
4. Human iPSC derived Cardiomyocytes (Beating cardiomyocytes, showing positive expression of Troponin T,
Nkx2-5 etc.) useful for preclinical drug screening and toxicology.
5. Human iPSC derived Hepatocytes (showing positive albumin expression and secretion, LDL uptake etc.)
useful for preclinical drug screening and toxicology.
6. Human adipose derived Mesenchymal Stem Cells (MSCs) showing >99% expression of CD90, CD105, CD73
etc., useful for research and development.
MAJOR ACCOMPLISHMENTS
FLAGSHIP PRODUCTS FOR PRECLINICAL CANCER RESEARCH
4 www.yashraj.com Volume 6, Issue 3, September 2019
CUSTOMISED SERVICES FOR DRUG SCREENING & TOXICOLOGY
Well strea li ed services developed and likely to be made commercially available soon are:
1. Bio-banking and collection of human bio-specimens for various disease indications such as cancer.
2. Customized development of primary human cancer epithelial cells collected from patients with Breast
Cancer, Ovarian Cancer, and Prostate Cancer.
3. Oncology Drug Screening Services: Use of a panel of primary cancer epithelial cells and established
immortalized cancer cell lines for customized drug screening and efficacy testing including dose and time
response studies using novel drug candidates and their combinations.
4. Customized development of primary human PBMCs (Peripheral Blood Mononuclear Cells) or other cell
populations derived from human blood.
5. Customized development of human iPSC from healthy subjects and patients with specified disease
indications.
6. Customized development of human iPSC derived cardiomyocytes (Beating cardiomyocytes, showing
positive expression of Troponin T, Nkx2-5 etc.) useful for preclinical drug screening and toxicology.
7. Customized development of human iPSC derived hepatocytes (showing positive albumin expression and
secretion, LDL uptake etc.) useful for preclinical drug screening and toxicology.
8. High-throughput Drug Toxicology Services: Use of iPSC derived cardiomyocytes and/or hepatocytes for
customized drug screening and toxicology portfolio development including cell viability, cell proliferation,
cell migration, mitotic indices, cell apoptosis, molecular gene and protein profiling, cell signaling and
electrophysiological analyses in response to dose and time response studies using novel drug candidates.
9. Customized development of human adipose derived Mesenchymal Stem Cells (MSCs) showing >99%
expression of CD90, CD105, CD73 etc., their differentiation into desired lineages useful for research and
development.
5 www.yashraj.com Volume 6, Issue 3, September 2019
WELCOME ABOARD: PRESIDENT R&D
We welcome emeritus scientist Professor Anjali Anoop Karande who has joined
our company as President, Research and Development. Professor Karande
holds PhD degree from Cancer Research Institute, Mumbai and had post-
doctoral training at the Department of Tumor Biology, Karolinska Institute,
Stockholm. She has served as faculty in the Department of Biochemistry, Indian
Institute of Science, Bengaluru for almost three decades, has published 160
research papers in national and international peer reviewed journals and
guided 29 PhD scholars. Her vast and rich experience in the development and
characterization of antibodies to a wide range of biomolecules, making
recombinant proteins employing various expression systems, purification of
proteins and glycoproteins from different sources and establishing bioassays
would contribute to the growth of Yashraj Biotechnology.
Our company had recently participated in the Annual Meeting and Expo organized by the American Association of
Clinical Chemistry (AACC) at Anaheim, California, USA as exhibitors in August, 2019. Our marketing team
interacted with top IVD companies at the Expo and discussed business synergies and other aspects of diagnostic
industry.
Its a matter of great pride that our colleague Dr. Gauri Awasthi, Manager, Techno-Commercial was bestowed with
the honor of being the AACC Artery Community Ambassador (India Section).
Glimpses of Yashraj Biotechnology Ltd booth at the recently conducted AACC EXPO 2019 at Anaheim, USA
AACC Artery Ambassadors sharing a light moment
at the 2019 AACC Expo at Anaheim, USA
Dr. Gauri Awasthi, Manager, Techno-Commercial
with Dr. Pradip Dutta, Senior Scientist, Siemens
Healthcare Diagnostics at the 2019 AACC meet
6 www.yashraj.com Volume 6, Issue 3, September 2019
Dr. Anjali Karande
SCIENTIFIC & BUSINESS NETWORKING AT AACC, USA 2019
7
INTERNATIONAL AWARDS
SPONSORED BY YBL
UPCOMING INTERNATIONAL EXPO AT
MEDICA-2019, DUSSELDORF, GERMANY
Yashraj Biotechnology Ltd has sponsored two distinguished international awards namely: IFCC
DISTINGUISHED CLINICAL CHEMIST AWARD , AND IFCC DISTINGUISHED WOMEN SCIENTIST
AWARD FOR CONTRIBUTION TO IN VITRO DIAGNO“TIC“ . This initiative of our company will not
only honor the recipients for their outstanding work but in addition stimulate and encourage
other scientists to accelerate their efforts in advancing clinical chemistry and laboratory medicine
for improved medical and healthcare.
These distinguished awards will be conferred to scientists and clinicians working in the field of
clinical chemistry and laboratory medicine or related disciplines during the World Lab Congress
planned in Seoul, South Korea, 24-28 May 2020, for which the International Federation for
Clinical Chemistry and Laboratory Medicine and its Award Committee will call for nominations
and identify the recipients.
Yashraj Biotechnology Limited will be participating in MEDICA-2019 at Dusseldorf, Germany
from 18-21 November, 2019 during which we can be reached at Hall 3 Booth H41
Our marketing and technical teams will be happy to meet you and discuss synergies.
For appointments please contact :
www.yashraj.com Volume 6, Issue 3, September 2019
Come and partner with us at Yashraj Biotechnology Limited in our
quest to make diagnostics affordable and easily accessible!
ADDRESS
YASHRAJ BIOTECHNOLOGY LTD.
Plot No. C232, TTC Industrial Area, MIDC,
Navi Mumbai – 400705, Maharashtra, India.
Phone No : +91 22 6216 6800
Mr. Bharat T. Dagha (Director, Business Development)