cGMP Pharmacy

In order to successfully conduct complex clinical pharmacology studies, extensive pharmacy capabilities are required. DVCR’s pharmacy team has over 50 years’ experience in early clinical development, with expertise in the handling and manipulation of investigational products across various routes of administration. These include, but are not limited to:

  • Injectable formulations (e.g., intravenous, intramuscular, subcutaneous)
  • Nasal Insufflation
  • Powder-in-Capsule (PIC)
  • Powder-in-Solution
  • Over-encapsulation
  • Many others

In order to successfully conduct complex clinical pharmacology studies, extensive pharmacy capabilities are required. DVCR’s pharmacy team has over 50 years’ experience in early clinical development, with expertise in the handling and manipulation of investigational products across various routes of administration. These include, but are not limited to:

  • Injectable formulations (e.g., intravenous, intramuscular, subcutaneous)
  • Nasal Insufflation
  • Powder-in-Capsule (PIC)
  • Powder-in-Solution
  • Over-encapsulation
  • Many others

Housed within our Phase 1 unit, the 2,500 square foot cGMP compliant compounding pharmacy contains five distinct areas for the preparation and storage of study drugs:

  • Main pharmacy area with closed cell insulation for maintaining environmental controls for ambient storage of study drug(s)
  • KLocking custom floor-to-ceiling cabinetry for non-controlled substances
  • USP-795 compliant negative pressure extemporaneous preparation room
  • USP 797 compliant ISO 8 (Class 100,000) Anteroom
  • USP 797 compliant ISO 7 (Class 10,000) Clean Room
  • Spacious storage room with cold storage units

Pharmacy Features and Equipment

New Thermo Fisher cold storage units including three refrigerators, one -20°C freezer, and one ultra-low freezer monitored 24/7/365 by the Thermo Fisher SmartVue Pro temperature monitoring system

350lbs. steel-constructed safe, securely bolted down with approximately 18 cubic feet of storage space and an electronic locking mechanism for secure storage of controlled substances

Semi-micro analytical balance for weighing powder API

Housed within a Type B PowderSafe™ enclosure on an anti-vibration table to improve balance performance

Class II, Type A2 Biological Safety Cabinet

Independent narrow spectrum 570nm amber LED lights for handling photosensitive API