SubscribeCarboGen and AMCIS' Center of Excellence in Highly Potent API Supply provides state-of-the-art containment chemistry services. Together, we support the manufacture of highly potent active pharmaceutical ingredients (APIs) for both clinical trials and commercial use.
Our service is backed by an infrastructure that includes process research and development facilities and a kilo-scale manufacturing facility.
The specialized laboratories and kilo-scale manufacturing equipment are designed to operate at or below an OEL of 0.3 g/m3 allowing safe handling of highly potent compounds of all categories including cytotoxics / cytostatics. We also offer manufacturing capability on a larger scale with equipment that can operate at or below an OEL of 10 g/m3.
Worker Safety and Product Quality
Our “protection cascade” of containment technology, systems and procedures ensures that we never compromise worker safety or product quality. In addition to the levels of containment described below, a rigorous system of Standard Operating Procedures (SOPs) and Unit Operation Procedures (UOPs), supplemented by extensive worker training, enhance safe working processes and awareness of potent compound safety.
Level 1: Sealed Processing
Wherever possible, all processes are contained within sealed process envelopes such as reactor systems, filtration and drying systems. When this is not possible, we consistently apply supplementary containment to ensure the presence of a first level of containment.
Level 2: Containment
Our second level of protection is achieved with our state-of-the-art containment equipment. This equipment enables us to handle highly potent raw materials, intermediates and APIs in liquid or powder form with a specialized dispensing, charging, liquid/solid separation and drying system.
Level 3: Room and Associated Environment
The infrastructure for our third level of containment applies to the containment facility itself and employs a “building within building” concept. All operations, equipment, supplies and even the building’s infrastructure are dedicated to containment activities. Air locks fully segregate our containment facilities within the building. All utilities such as vacuum, ventilation, and waste disposal systems, are separate from our general systems, and our HVAC (Heating, Ventilation, and Air Conditioning) system delivers high efficiency filtration, in and out. Access to the containment facility is restricted to the containment team who works exclusively on these projects by a swipe card entry system. We also have in place a clearly defined, auditable waste management plan and rigorous emergency procedures and plans.
Level 4: Personal Protective Equipment and Occupational Health Monitoring
Personal Protective Equipment (PPE) serves only as our final backup at the end of the protection cascade. Occupational Health procedures ensure an ongoing, well-defined health monitoring program for all our employees who have contact with our containment activities.
True Center of Excellence
A true Center of Excellence within CarboGen and AMCIS’ chemistry practice, our containment capability fits with our scale of operations for APIs to support non-potent parts of the synthesis process.
Oncology Drug Development
We specialize in helping our pharmaceutical customers bring oncologic drugs to the market. Our containment capabilities allow the safe handling of highly potent compounds of all
categories including cytotoxics /cytostatics.
