Clinical Manufacturing

GMP Manufacturing Capabilities and Capacity

Our filling capabilities include vials, syringes, and cartridges for both liquid and lyophilized formulations with a high accuracy for both aqueous and viscous solutions. Automated filling capabilities allows us to offer a wide range of batch configurations and sizes.

• 1 – 100 L batch volumes depending on product characteristics and filling volumes
• Max liquid batch size: 20,000 vials (CAM) and 7,500 (GLA)
• High potency formulations
• Controlled substances
• Cytotoxics

Our fill/finish suites have independent HVAC systems that allow us to handle cytotoxic and noncytotoxic materials. Our manufacturing philosophy is based upon the use of single use, fully disposable fluid pathways.

All our manufacturing spaces are within traditional EU classification:

• Aseptic filling – Grade A closed RABS cabinet within Grade B background
• Bulk formulation – Grade C
• Washing/Loading of Autoclave – Grade C

We offer a wide array of drug container closure systems for your liquid/lyophilized drug product including:

• Syringes (1 mL – 2.25mL)
• Cartridges (1.5 – 3 mL)
• Vials (2mL – 20 mL) or GLA (2 mL – 50 mL)

Regulations Followed

Current Good Manufacturing Practices (“cGMPs”) – Applicable regulatory requirements with respect to a country or regulatory jurisdiction in the USA and UK as amended from time to time, for the then-current standards under Applicable Law for the Manufacturing, preparation, processing, labeling, packaging, and distribution of pharmaceutical and/or biological products (and components thereof), including as set forth in (a) 21 U.S.C. Section 501(a),21 C.F.R. § 11, 210, 211, EU GMP Volume 4, and the guidance documents issued by the FDA and MHRA.

Registrations/Licenses

Camarillo

The company has carried and maintained a Drug Manufacturing License from the State of California Department of Public Health Food and Drug Branch since 2012.

The company is registered on the FDA Drug establishment site. The FDA Facility Establishment Identifier Number (FEIN) is: 3006188248.

Glasgow

The company holds an Investigational Medicinal Products Authorization licensed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).  MIA (IMP) Number 19124.