Manufacturing

Our High Containment Operations (HCO) handle highly potent compounds through a closed manufacturing system with a capability of handling substances down to an occupational exposure level (OEL) of 0.1 µg/m3 or less. We currently have multiple dedicated processing suites and supporting infrastructure, along with a dedicated packing room, remote data acquisition system & documentation room. For each chemical moiety introduced, aggressive assessment studies are performed to ensure there is no contamination.

Our analytical testing labs are furnished with appropriate equipment such as safety workbenches for sample preparations, containment hoods and isolators for testing samples, and separation from the normal lab areas and with limited access. Stason complies with all applicable laws with respect to the environment, occupational health and safety, public health & safety, waste disposal, and holds all current and applicable governmental licenses, approvals, permits & authorizations.

Stason currently references the SafeBridge® categorization scheme and works with SafeBridge® Category 1-4 compounds. The SafeBridge “Occupational Health Toxicity/Potency Categorization and Handling Practices” system (copyright SafeBridge Consultants, Inc., Fifth Revision – January 2002, pp.12), is a four-category system to characterize compound potency.

Located in Irvine California, Stason’s cutting-edge cGMP manufacturing capabilities include facilities from pilot plant and clinical scale production, through to commercial batch manufacturing. The manufacturing facility resides within a sprinkler-equipped, concrete building that encompasses approximately 37,0000 sq. feet, and is capable of producing over 2 billion oral doses per year, with a batch size capacity of 0.5 kg – 600 kg. The clean rooms (Class 100,000/ISO Class 8) have a minimum of 12-foot ceilings. The manufacturing room environments are designed to maintain a temperature of 18-24°C. The air-handling system provides a minimum of 20 changes of filtered air per hour. The air quality (air particulate & microbial levels) is monitored periodically according to Stason SOP.
Stason also operates a dedicated High Containment facility, which is segregated from our Non-High Containment operations, and consists of multiple processing suites, a dedicated packaging room, a documentation room, and field support offices. The air handling system provides a minimum of 40 changes of filtered air per hour.

In addition to our solid dosage manufacturing capabilities (tablets & capsules), Stason offers injectable & liquid manufacturing through our partnership with Standard Chem. & Pharm. Co. Ltd. in Tainan, Taiwan. The Taiwan GMP facility located at Campus2, accommodates both liquids and ointments. The GMP facility on Campus1, is devoted to injectables and offers: lyophilization, suspension, powder filling, and liquids. For more information regarding our manufacturing partnerships in Taiwan, please inquire with us, inquiry@stason.com.

Stason works with virtual start-up companies/inventors, through to mid-size, and top-20 pharma companies. We’re able to enter the development & manufacturing arena at any stage, providing services through to your commercial expectations, and producing up to 2 billion oral doses per year. For semi-solid dose formulations, we typically handle bench-top through phase 2 clinical trial production.

• Bench-Top (0.5 – 1 kg)
• Pilot (3-5 Kg)
• Commercial (50-600 kg)

The future of CMC regulatory review is based on Quality-by-Design (QbD), and the CMC Regulatory Decision is based on CMC Quality & Performance. Stason has quality control systems, which require strict adherence to cGMP regulations. Total system quality is monitored from sample receipt to report generation. Stason offers quality control (QC) testing for Active Pharmaceutical Ingredients (API’s), pharmaceutical intermediates, excipients, and finished products.

Stability storage conditions meet ICH guidelines. Each cGMP environmental chamber operates independently, with separate temperature controls, and monitored continuously through a validated environmental monitoring system. All storage chambers are supported by full generator back-up, in case of power failure.

ICH Stability Chambers:

• 25°C/60%RH
• 30°C/65%RH
• 40°C/75%RH
• Customized Conditions (for example: Zone IV).

Stason performs release & stability testing for small molecule drugs (brand, generic) and diagnostic products. Appropriate sampling and testing methods are determined, documented and executed. Analytical services supporting stability programs include: long-term stability testing, accelerated stability testing, comparative stability testing, and forced degradation studies.

Stason offers the ability to package solid, and semi solid non sterile and sterile dosage forms into a variety of final packages which include bulk, bottle, or blister.

Our capacity includes:

• Multiple automatic encapsulation machines with capacity of 50,000 capsules per hour. Capable of filling powder, granules, pellets, and minitablets from Size 00 to 04
• Automatic packaging line with capacity of up to 100 bottles/minute
• Induction Cap sealing machine
• Unit dose blister design & development

Our global integrated network of affiliates and distribution sites allows us to package and distribute supplies worldwide. Multiple automatic and semi-automated packaging lines are used for clinical and commercial packaging processes. Manual packaging is available for custom configurations. Our global distribution network adheres to the strict rules and regulations necessary for global transfer.