CBCC Biorepository capabilities

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USA ● INDIA 1

Transcript of CBCC Biorepository capabilities

Page 1: CBCC Biorepository capabilities

1 USA ● INDIA

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CBCC Group - Journey at a glance

1984 Founded by Dr. Ravi Patel with small cancer clinic of 12,000 Sq. ft.

1990 Expanded into a larger facility with several stations

Began to participate in oncology clinical trials with affiliation to UCLA.1995

1996 Renamed clinic to Comprehensive Blood & Cancer Centre (CBCC).

2007 Opened a new 70,000 sq ft cancer centre becoming the largest centre on west coast, USA.

2008 Inaugurated a brand new centre CBCC CyberKnife® Center.

2011 Acquired an HDXT MRI for expanding diagnosis for Breast Cancer.

2015

Started operation in Gujarat, India.

Started operation in other Indian states Chaatisgadh, Madhya Pradesh and Andhra Pradesh.

Started operation in Tamilnadu, India.

2012 Acquired Vibgyor Research India to manage India Operation.

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• Purpose-built, state of the art Bio repository facility for receipt, processing, storage and archival of human bio specimens in India and the US

• Seven (7) Oncology sites managed by CBCC in India in addition to a network of > 80 sites across India

• Our experienced team trains the Investigators and site staff to ensure high quality specimen collection & handling

• Compliance with Ethics committee approved protocol and National & International guidelines (ICMR, ISBER, NCI, HIPAA)

• Processed over 80,000 specimens for Oncology in the US till date• Processed over 4,000 specimens across multiple sites for Oncology in India in a

span of over a year• Robust systems in place to ensure Quality compliance at all levels

About CBCC’s Biorepository

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Infrastructure at our Biorepository

Short to long-term specimen storage

• State-of-the-art banking facility

• Custom designed LIMS complying with all regulatory requirements

• Qualified, Trained and experienced staff led by a Pathologist

Safety & Security

• Storage equipments with monitoring system to monitor temperature and humidity - 24/7

• Emergency back-up (72hrs) generators for total support coupled with 24/7 emergency response services

• 24-hour restricted access facility with security surveillance

• Secured data access to authorized personnel via log in and password protection.

Flexibility & Scalability

• Range of frozen storage conditions including ambient, 2 to 8°C, -20°C, -40°C, -80°C, and -190°C vapor phase liquid nitrogen & dipin LN2 (-196°C)

• Adaptable storage options e.g. freezer assignment for larger containers / dedicated single shelf to cater to individual requests

• Capacity to store broad sample types including plasma, serum, whole blood, DNA, PBMC and tissue

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Specimens we can source

• Tissue samples with well preserved RNA and proteins• Samples from a wide variety of organs, diseases, cancers and

adjacent normal tissue• Tissue samples available with matched serum

Human Tissue

• FFPE samples from various diseased and adjacent normal tissuesHuman, Formalin-Fixed,

Paraffin-Embedded Tissue (FFPE)

• Samples from several disease types and disease-free normal controls

• Collected by validated protocols Human Serum

• Fresh, whole Blood & Peripheral Blood Mononuclear Cells (PBMCs)• Plasma & Serum• Buffy Coat & Circulating Tumor Cells (CTCs)

Blood Products

• Saliva, Cerebrospinal and other fluids• Urine, Nail clippings & hair• Semen & cervical swabs

Others

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Therapeutic areas

• Breast Cancer, Lung Cancer, Thyroid cancer• Head and neck cancers• Prostate cancer, Gynecological Cancer, Colorectal Cancer

Oncology

• Acute and Chronic Myeloid Leukemia; Acute and Chronic Lymphocytic Leukemia

• Multiple Myeloma Thalassemia• Myelodysplastic Syndrome

Hematology

• Rheumatoid Arthritis• Systemic Lupus ErythematosusImmunology

• Type I & II Diabetes• Cirrhosis of liver

Metabolic diseases

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Our sample collection process

Protocol development

Training of Investigators/site staff/BR monitor

on protocol

IEC approval and Patient consent

Specimen collection &

labeling using project specific collection kits

Review & monitor patient

consent and data collection

procedures

Storage at sites, packaging and

shipping to CBCC Biorepository

under controlled conditions

Customized case report forms as per the collection protocol to capture the exact type of data needed e.g. clinical, molecular, demographic, lifestyle, family history etc.

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Why select us for your Biorepository requirements?

Project Management

Project delivery on-time to accelerate your

research programs

Project visibility – Open & Honest

communication

Comprehensive project management plans & updates at each stage

High Quality

100% consent and 100% monitoring

Collection according to uniform validated

protocols across all sites

All our operations abide by the ISBER

Annotated samples

Detailed demographic information, including

family history

Clinical diagnostic information

Complete medication history & full pathology

report

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Why select us for your Biorepository requirements?

Logistics

Logistics partners capable of shipment

compliance management

Real time shipment tracking

Temperature monitoring

Customized sample

sourcing Site selection as per

specimen requirements

Feasibility assessments to estimate accurate

timelines

Project specific collection kits

Ethical consideration

Adherence to all applicable ethical, legal & regulatory guidelines

IEC approved protocols for sample collection

Sample identification only by Unique codes

to protect patient privacy

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THANK YOU