CLINICAL PACKAGING AND LOGISTICS

​

Pacific BioPharma Logistics was founded in 2017 in Poway, nearby to the entire San Diego area biotechnology community. PBL is the foremost and most cost-effect provider of clinical trial material depot, packaging and logistics services, including: packaging, labeling, kitting, storage, distribution and returns/reconciliation. Our services support biotechnology, pharmaceutical, vaccine, and medical device applications.

PBL understands the customer focus, responsiveness and attention to detail required for successful clinical trial material logistics support. We can create customized Study Kit designs for all dosage forms, label and package clinical materials and store finished product at specified controlled temperatures. PBL ensures that clinical trial materials are reliably delivered to clinical sites worldwide through established relationships with qualified carriers.

PBL offers the highest level of customer focus, quality, reliability, responsiveness and cost effectiveness. PBL offers customized, tailored, solutions to match unique clinical trial needs. PBL supports studies from pre-clinical stage through to Phase III clinical trials. We are unsurpassed in our ability to assist small and virtual companies requiring third-party clinical packaging and logistics services.

PBL clinical trial material packaging and logistics services include:

· Primary and secondary labeling

· Study Kit design, sourcing and packaging

· Secondary packaging

· Cold chain distribution

· Long-term storage

· Returns, reconciliation and destruction

· Labels able to maintain adhesion at temperatures of LN2, -80 to -70 °C, -20 °C, 2-8 °C and CRT

· Multi-panel labels, booklet labels, blind/double blind labels either produced in-house or source locally

· Ancillary supplies sourcing

GMP Storage

PBLI’s cGMP storage facility offers multiple conditions to accommodate your clinical trial supply needs.  We can handle small-scale Phase I studies to large Phase III studies.  Standard USP conditions include:

​

          Ambient Storage

          Controlled Room Temperature (20° to 25° C)

          Refrigerated (2° to 8° C)

          Frozen (-20° C)

          Ultra-Frozen (-80° C)

          Cryo Storage (-196° C)

          Other non-standard conditions available

          We can handle cytotoxic, highly potent and DEA Scheduled Materials (Category II-V).

          All storage areas are monitored 24/7.  Our facility includes a security system with motion sensors as well as restricted access throughout our facilities.

Global Distribution

We can prepare and ship your materials to any clinical study sites around the globe in the most cost-effective manner. Our partners are strategically positioned around the world, allowing for smooth shipping and customs release of your clinical supplies.  We deliver !

          Shipment of Temperature-Controlled Products Worldwide

​

          Pre-qualified shippers for up to 120 hours, at temperatures of -20°C, 2-8°C, and CRT

​

          Dry Ice (-70°C) or Gel Pack Shippers (2-8°C)

​

          Cryogenic Shippers

​

          Qualified Global Depots

​

          Temperature monitoring using the most advanced USB devices

​

          Web-based 3PL Inventory Monitoring System

Aliquoting Services

In addition to storing material, we can aliquot samples from bulk product while maintaining your GMP chain of custody. Drug Product Drug Substance (API)
Reagents Raw Material Powder, Lyo or Liquid