Boca Biolistics, LLC.

Human tissue and matched sets are collected under strict collection protocols and patient consent. BBL has exclusive collection sites in Peru, Nigeria, USA as well as Ukraine. Our tissue network can provide cancer tissues (Lung, Colon, Breast, Prostate, GEJ, Renal, etc.) and prospectively collect matched tissue and plasma sets. BBL's CDx division can assist pharma and biotech clients with companion diagnostic development.

Through the IVD CDO Services division, BBL offers a full suite of clinical trial management services from initial study design to final regulatory submission. As a full service BBL has successfully completed clinical validation studies in the United States, Africa, Europe, Asia and South America. BBL offers a full ’turnkey’ approach to outsourcing clinical validation studies. Our proprietary network of principal investigators allows us to rapidly identify some of the most significant and rare global patient populations and decreases the time to market of products. BBL’s access to central laboratory services, provides the value‐added testing necessary to demonstrate clinical efficacy.

OVERVIEW OF IVD CDO SERVICES

✔ Full‐service performance diagnostic and pharmaceutical trials
✔ The development of HIPAA‐compliant informed consents, collection protocols and CRFs
✔ Institutional Review Board (IRB), Independent Ethics Committee (IEC) and Ministry of Health (MOH) submissions, both

DOMESTIC AND INTERNATIONAL

✔ Site selection, initiation and monitoring, utilizing BBL’s proprietary Investigator Network
✔ On‐site sample management and logistical support
✔ Short‐ and long‐term storage of samples
✔ Access to central laboratory services, including parallel testing and data transmission
✔ Management and analysis of data collected during the study
✔ Consulting services to prepare submissions to relevant regulatory bodies, such as the US Food & Drug Administration (FDA)

OVERVIEW OF BOCA BIO’S INVESTIGATOR NETWORK

✔ The reach of BBL’s Investigator Network extends to 5 continents and to over 50 countries around the globe
✔ Our Principal Investigator Network (PIN) is comprised of over 250 investigators, globally
✔ Members of the PIN are partners of Boca Bio and critical enablers of BBL’s clinical trial and biological sample services
✔ BBL leverages the reach and expertise of its Global Investigator Network to enable the recruitment of hard to find patient populations
and procure rare biological materials.
✔ Boca Bio has managed IVD Clinical Trials for some of the largest IVD companies, including Roche, Abbott, Ortho‐Clinical Diagnostics, Bayer, Gen‐Probe and others
✔ BBL has the capability, though this network, to collect a wide variety of patient populations and various matrices.

Match patient sets and longitudinal sets are also available upon request. With our Central Laboratory Service, we can also provide any testing needed on any of our over 250,000 inventoried specimens or prospectively collected samples.

• Hepatitis/HIV
• Autoimmune
• Cardiac Disease
• Thyroid/Endocrinology
• General Chemistry
• Normal/Healthy Donors
• Therapeutic Drug Monitoring
• Cancer
• Drugs of Abuse
• ToRCH IgG & IgM
• Diabetes
• High Risk Population

✔ Samples are obtained by clinicians who are part of the Boca Bio’s Global Investigator Network, received and processed by BBL sample processing technicians and then archived in our Bio‐Repository.

✔ Sera and urine sample sizes ranging from 0.5 to 1,000mL. FFPE tissue ranging from individual slides to complete blocks. ‘Snap Frozen’ and fresh tissue ranging from several to hundreds of grams.

✔ Samples are stored at BBL’s Bio‐Repository facility in Coconut Creek at temperatures as cold as ‐80º C to ensure product integrity.

✔ Specimens are accompanied by a case report form (CRF) or clinical data that can include a donor’s demographic and case history (testing, therapy and family) information.

✔ Every sample is procured under IRB, IEC and/or MOH approved collection protocols.

✔ Each biological sample is characterized by various laboratory tests to obtain qualitative and quantitative data related to biochemistry, hematology, infectious disease serology, antigen/antibody detection and viral RNA and DNA presence.

Boca Bio can accommodate almost any request for specimen needs for your Discovery or Development phases of your product life cycle. Please contact us to discuss your current or near future needs.

BBL offers Histology Services to complement our tissue products. Using state-of-the art technology, BBL can process tissue samples that will meet your needs and accelerate your research. Boca Bio’s staff has extensive expertise and is available to discuss your custom needs. These services include general and complex histological procedures.

Pathology Service for Researchers

• Pathology lab services
• Evaluation of tumor tissues
• Consultation services

Sectioning of Human Tissue Samples

• Paraffin Tissue
• Frozen Tissue

Custom Histology

• H&E stain
• Other stains and services

Clinical and Anatomic Pathology Services

BBL is an international collection network organization with PI's and qualified sites in over 30 countries and 5 continents. BBL has over 20 years experience in managing ex-US clinical trial collection studies, interacting with relevant MOH, IEC and other regulatory bodies in the completion of studies.

Medical Devices & Diagnostics Services

Cells and Tissues Services

Biology Services

Clinical Trials, Consulting, and Management Services

BBL biostorage services, (biobanx), deliver precise specimen management including:

21 CFR 11-compliant inventory management system
Centralized specimen storage
Trial-specific repositories and specimen registration
Electronic temperature monitoring of storage locations at all thresholds
In-place disaster recovery/business continuity plans:
Redundant temperature storage chambers
Emergency power supply
Web portal secure repository access and management
Certified distribution and shipping logistics

Our comprehensive biobanking services provide:

Logistics Management: BBL ensures that your assets are accessible for on-demand retrieval and shipment while maintaining required temperatures and chain of custody as specified in your protocol.
Storage Features
State-of-the-art cGMP-compliant, ISO 13485:2016 accredited storage facility
Fully validated and mapped backup freezers
Onsite storage capacity of more than 5,000,000 specimens
Security and Control
Backup generators and redundant HVAC systems
21 CFR 11-compliant 24/7/365 monitoring system and alarm response
Controlled access to all storage units
Redundant security systems for entire facility and The Biobanx repository.
Clinical Trial Sample Management: Precise sample management is a vital component of today’s clinical trials. The post-trial contribution of study samples may include retesting for data or regulatory compliance, or serve as the vital resource in the development of a companion diagnostic (CDx). A comprehensive specimen management plan, including centralized biostorage, should be a part of your initial trial plan.
Cell Banking: Storing the cells of specific genomes for future use requires precise bioprocessing, handling, and inventory controls to ensure cell identity, purity, and viability

Human Tissue Services

Human Biospecimens Services

INNOVATION. PERFORMANCE. QUALITY. IT’S IN OUR DNA.
Boca Biolistics Reference Laboratory is a research-driven organization dedicated to being a leading specialty laboratory partner by
acquiring, evaluating and implementing the latest technologies to pioneer the advancement of diagnostic medicine.

We provide test results and support services to health systems, hospitals, doctors and commercial reference laboratories needed to improve patient health outcomes. Our strategic collaborations with diagnostic and research companies help solve difficult problems while supporting diagnostic innovations.

We have a specialized test menu and pride ourselves in our industry-leading turnaround times and unparalleled client support.

www.bocabiolab.com