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cGMP pharmacy

A 2,500 square-foot cGMP-compliant compounding pharmacy inside our Phase I unit, DEA-registered to handle and store Schedule I-V controlled substances.

Discuss your study drug needs

What we deliver

  • Study drug preparation across multiple routes of administration, including injectable formulations (intravenous, intramuscular, subcutaneous), nasal insufflation, powder-in-capsule, powder-in-solution, over-encapsulation and others
  • Secure storage of controlled and non-controlled study drugs, backed by DEA registration for Schedule I-V substances
  • Sterile and non-sterile compounding in USP 797 and USP 795 compliant rooms
  • Continuous, web-based temperature monitoring throughout

Experience snapshot

2,500 sq ft+

cGMP-compliant compounding pharmacy

5

Distinct preparation and storage areas

50+

Years combined early phase pharmacy experience

Schedule I-V

DEA-registered for controlled substances

Our pharmacy approach

Our pharmacy is organized into five distinct areas that supports the storage and handling of study drugs from receipt to destruction or return. A main pharmacy area with closed-cell insulation maintains environmental controls for ambient storage, with locking floor-to-ceiling cabinetry for non-controlled substances. Dedicated areas supporting study drug preparation include a USP 795 compliant negative-pressure extemporaneous compounding room, a USP 797 compliant ISO 8 anteroom and a USP 797 compliant ISO 7 cleanroom, along with a separate room for cold storage units.

Integration of the pharmacy within our Phase I unit allows prepared doses to reach the clinic quickly and under controlled conditions, which keeps dosing on schedule and reduces handoffs to maintain a strict chain of custody.

Your pharmacy leadership

Our Pharmacy Operations team is led by experienced professionals with more than 50 years of combined expertise in early phase research, including nasal insufflation, powder-in-capsule and over-encapsulation dose preparation. The team provides consistent pharmacy leadership and maintains rigorous preparation and handling standards for investigational products across various routes of administration.

Todd Janssen

Director, Pharmacy Operations

18 years of experience

Donnie Keeney, PharmD

Manager, Pharmacy Operations

9 years of experience

Technology, tools and systems

Our pharmacy is built for controlled conditions and secure handling:

  • Cloud-based automated continuous monitoring of temperature and humidity, as well as pressure differential and particle count monitoring in positive-pressure rooms
  • Cold storage units ranging from +4°C, −20°C and ultra-low −80°C, monitored 24/7/365 by the Thermo Scientific™ SmartVue Pro™ temperature monitoring system
  • A 350 lb. steel-constructed safe, securely bolted down, with approximately 18 cubic feet of storage and an electronic locking mechanism for secure controlled substance storage
  • A semi-micro analytical balance for weighing API powder, housed within a Type B PowderSafe® enclosure on an anti-vibration table to improve balance performance
  • Two stainless steel Class II, Type A2 biological safety cabinets
  • Independent narrow spectrum 570 nm amber LED lighting for handling photosensitive study drugs
  • Dedicated rooftop units providing HEPA filtration throughout the pharmacy
  • Biometric facial screening controls access into the pharmacy
Pharmacy Team in the lab

Quality, standards and compliance

The pharmacy is cGMP-compliant, and its preparation spaces are built to USP 795 and USP 797 standards, including an ISO 7 cleanroom and ISO 8 anteroom. DEA registration covers the handling and storage of Schedule I-V controlled substances, and continuous environmental monitoring means the conditions behind every prepared dose are recorded and available for review. The pharmacy team has robust Standard Operation Procedures (SOPs) that dictate proper handling of products from receipt at the site until the product leaves the clinical pharmacology unit after study completion. 

Connected across the full study lifecycle

Our pharmacy is one part of a full-service early phase model, working seamlessly with our Phase I unit, and broader CRO services.

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Featured study

Challenge

During a double-blind clinical study, the active investigational product (IP) was a visibly different milky-white solution, while the placebo was clear. Because the IP was administered by infusion, additional masking measures were required to prevent the appearance of the solutions from compromising the study blind.

Approach

The Pharmacy Team proposed that one member of the clinic’s dose administration team be unblinded. This staff member primed the infusion lines before the Pharmacy Team covered them with an amber overlay, concealing the solution’s appearance from blinded study personnel and subjects. The sponsor approved the approach, and the process was incorporated into the pharmacy manual.

Outcome

The approach preserved the blind throughout the study, safeguarded study integrity and enabled the successful execution of blinded dosing from start to finish.

Related resources

Evaluating a pharmacy for your early phase study?

Talk to a pharmacy team built for complex formulations including controlled substances.

Learn how our compounding spaces, storage and monitoring support your
study drug from receipt through dosing.

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