Pharmatek offers full development services for highly-potent compounds including:
- Analytical methods development
- Preformulation testing
- Formulation development
- GMP manufacturing of phase I/II clinical supplies
- Stability storage and testing services (all ICH storage conditions)
- Technical transfer for commercialization
- Clinical distribution and fulfillment
Handling highly-potent compounds requires highly specialized facilities and controls. Pharmatek’s focus on pharmaceutical chemistry development, combined with dedicated facilities, ensures your molecule moves efficiently from discovery to clinical trials.
Highly-potent development services are carried out in Pharmatek’s dedicated, state-of-the-art facility. Our 18,000 ft2 facility, specifically designed and built for the development and manufacturing of highly-potent drug products, includes formulation and analytical labs, and high-containment manufacturing suites, certified and validated to ISO Class 8, US Class 100,000. Pharmatek uses a combination of exposure control systems and facility design elements to prevent cross contamination and to ensure the safety of personnel, according to the Pharmatek Control Banding System.
The Pharmatek Control Banding System, shown below, is based on the results of surrogate monitoring and airborne particulate testing of the work spaces within the highly-potent development and manufacturing facility. The results demonstrate the engineering controls and practices at Pharmatek are effective at controlling airborne particulates down to a 0.1 µg/m3 level, but when combined with respiratory protection factors and process specific enclosure systems, particulate levels are much lower. The facility and systems position Pharmatek as an industry leader in the development and manufacturing of New Chemical Entities (NCEs).
From analytical method development to early phase clinical trial material manufacturing, all of your highly-potent development needs are handled under one roof, which allows us to create a streamlined solution for your development goals.
The facility includes a dedicated development lab with the following design aspects:
- Type II/Class IIb containment hoods
- Separate and dedicated powder rooms
- UPS and generator backup systems for stability chambers
- Dedicated nitrogen, argon and purified water systems
- Separate and dedicated R&D washroom
Manufacturing suites are certified and validated to ISO Class 8, US Class 100,000 high-containment. Suites are designed with barrier technology for cGMP manufacturing of final form drug products. Suite design aspects include:
- Airlock control and alternating “serpentine” pressure design system to prevent cross contamination, monitored by digital pressure system.
- Single-pass, non re-circulated air with filtered low-wall returns
- Uni-directional equipment and personnel flow
- Dedicated HVAC and HEPA filtration systems
- Hard-lid ceilings, epoxy painted walls and welded sheet vinyl flooring
- Controlled access to highly-potent handling areas
- ILC Dover soft-wall equipment and process enclosure system to ensure containment
- Temperature and humidity monitored by Rees computer system
- Personnel protected through strict gowning and control procedures
- Routine assessment of viable and non-viable air particulates performed to ensure best-working practices and operation within assigned Occupational Exposure Band (see below)
- Argon and Nitrogen gas capability for inert/dry environment control
- Clean dry air system for automated equipment
- GMP manufacturing washroom and equipment & product storage integrated within cleanroom facility
Pharmatek Control Banding System & Categorization Service
In order to conform to the specific needs of our facilities, processes, and personnel, Pharmatek has developed its own compound classification scheme. Active pharmaceutical ingredients are categorized according to their inherent toxicity characteristics and pharmacological potency.
A compound’s placement in the Pharmatek Control Banding System is risk-based and takes into consideration the challenges of limited data availability at the pre-clinical and phase I/II development stages. For instance, many compounds in the early post-discovery phase lack acute and long-term potency data, but often the structure of the molecule is known. Based on this limited information, we can compare your compound to other exemplar molecules and get a predictive range of its likely potency.
Find out where your compound falls, Let Pharmatek categorize your NCE
Contact us to learn more about our highly-potent drug development services, schedule a site visit, or to see where you compound lies in the Pharmatek Control Banding System.