The Pharmaceutical Development Institute (PDI)  https://uripdi.thinkific.com/ is a multi-functional operation that supports the biopharmaceutical industry, entrepreneurial academic researchers, and student education. The main PDI operations take place in a 7,000 sq ft pharmaceutical cleanroom manufacturing/training facility in the lower level of the URI College of Pharmacy (Avedisian Hall), where solid oral dosage forms (e.g., tablets, capsules, powders, etc.) are developed and manufactured. The PDI has high-tech equipment, three separate manufacturing suites, and a team of highly experienced veteran scientists and engineers from the pharmaceutical industry. The fundamental goal of the PDI is to enable established and start-up pharmaceutical firms, including entrepreneurial academic and medical researchers, to bring new innovative drugs into necessary development studies and first-in-human clinical trials. A separate 1,500 sq ft analytical development/quality control laboratory is also an integral part of the PDI, where all raw materials and final products undergo rigorous quality testing. The facility operates under Good Manufacturing Practices (GMPs), and the staff team is highly experienced and well-versed in the guidance and requirements for submissions to regulatory authorities (e.g., INDs, IMPDs, CTAs, NDAs, BLAs, etc.).

Another key mission of the PDI is to train individuals, both students and external professionals, for advanced careers in biopharmaceutical manufacturing. To date, the PDI offers beginner, intermediate, and advanced training programs for employees in the biopharmaceutical industry. Individuals are given the opportunity to gain hands-on experiences with equipment used in cleanroom environments meeting ISO 5 to ISO 8 specifications. Emphasis is placed on aseptic processing (from inoculation in shaker flasks through bioreactors transfers), viable and non-viable environmental monitoring, cell culture, cell harvest, and purification. Currently, internships are available for URI students to work side-by-side and hands-on with the PDI staff, and the PDI expects to offer one or more courses related to “real-world” pharmaceutical development and the biopharmaceutical industry, taught by PDI staff and other experienced biopharmaceutical industry professionals.

PDI services include:

Contract Development and Manufacturing

A 6,000 sq ft manufacturing facility, including 3 independent GMP process suites, provides formulation/process development and manufacturing of solid oral dosage forms (e.g., tablets, capsules, powders, etc.). The equipment and capabilities assist clients to achieve product quality expectations and meet clinical development milestones with adequate supplies for development, stability, animal/toxicology studies, and human clinical trials.
Major equipment/instrumentation includes:

• Tablet Presses (Natoli and Vanguard) – the PDI has three tablet presses (single-station manual, single-station automatic, and 16-station rotary) with a capability of up to 28,000 tablets/hour.
• Encapsulation Machine (Vanguard) – a semi-automatic encapulator is available to manufacture powder-filled two-piece gelatin and HPMC capsules.
• Tablet Pan Coater (Vanguard) – coating equipment is able to apply non-functional (g., aesthetic, color, etc.) and functional (e.g., taste masking, enteric, etc.) coatings to the surfaces of tablets.
• Roller Compactor (Freund Vector) – facilitates densification of fine powders into flowable and compressible granules without the need for granulating solutions.
• High Shear Granulator (Freund Vector) – facilitates densification of fine powders into flowable and compressible granules using aqueous- or solvent-based granulating solutions.
• Fluid Bed Systems (Glatt) – the PDI has two small-scale fluid bed systems, which are capable of granulation, drying, and coating.
• Powder Blending (Vanguard) – V-blender that operates on diffusion blending of powders.
• Mills (Vanguard, Globe Pharma, Freund Vector) – several mills available to reduce particle size of large granules for downstream processing.
• Testing Instruments – tablet hardness tester, friabilator, powder loss-on-drying, sieve analysis (particle size distribution), etc.

Analytical, Quality Control, and Stability Testing

A 1,500 sq ft analytical, quality control, and stability testing laboratory offers full analytical and quality control services, including method development and qualification, raw material and compendial testing, drug substance and drug product testing for development, release, stability, and method transfer. Major instrumentation includes:

• Ultra-Performance Liquid Chromatograph (Waters) – UPLC equipped with Photodiode Array Detector (PDA) and Charged Aerosol Detector (CAD) is available for quantitative analysis of components in a complex mixture. The PDA detector allows for multi-wavelength measurement and generation of spectra for each component. The CAD detector is useful for quantitating compounds that do not contain chromophores.
• Gas Chromatograph (Agilent) – GC capabilities with Flame Ionization Detection (FID) is targeted for installation in 1Q/2023. The GC/FID permits analysis of residual solvent levels in pharmaceutical products.
• Automated Dissolution System (Apparatus I & II) (Distek) – Instrument is utilized to evaluate drug release characteristics and consistency of drug products. Apparatus I (rotating basket) and Apparatus II (rotating paddle) methods are routinely used for release and stability testing of solid oral dosage forms, such as tablets and capsules.
• Disintegration System (Pharmatron) – Instrument is utilized to measure the amount of time it takes a sample (usually a tablet or capsule) to totally disintegrate inside a liquid medium.
• Coulometric KF Titrator (Metrohm) – Coulometric KF determines the water content (bound and unbound water) in a sample using classic titration. The instrument can determine low water levels (g., 0.001 – 1% water) and is routinely used for release and stability testing of solid oral dosage forms, such as tablets and capsules.
• Stability Chambers – several stability chambers will be available (target installation 1Q/2023) for controlled temperature and humidity storage of pharmaceutical drug products.

Customized Training

The PDI offers specialized biopharmaceutical training to specific industry segments and utilizes a 1,000 sq ft training facility. The PDI works collaboratively with client firms to customize training to their unique and detailed process-specific requirements, thereby enhancing employee capabilities and expertise. Taught exclusively by industry professionals, the workshops include: Introduction to BioPharmaceutical Manufacturing, Cell Harvesting, Aseptic Processing, Introduction to Validation, Quality Assurance and Compliance, Advanced Chromatography, and other specialized topics.
Major equipment/instrumentation includes: