You have received funding for a drug development project, and have an innovative idea, full of unique technology and intellectual property, although challenges to commercialisation are yet to be solved.
QuaDPharma offers small to mid-scale current good manufacturing practice (cGMP) manufacturing services for the pharmaceutical industry.
Filling of semi-solids and liquids
QuaDPharma provides clients with a more collaborative style of manufacturing by combining innovative formulation and packaging technology.
The company’s team is a group of pharmaceutical professionals experienced in drug and device manufacturing for the pre-commercial and commercial life science markets.
QuaDPharma’s manufacturing capabilities include the formulation and filling of semi-solids and liquids under bioburden-reduced or aseptic conditions.
The company produces packaging for semi-solids, liquids and solid dosage forms at its FDA-approved facility, which operates under ‘Quality before Delivery’ (QuaD).
Pharmaceutical support services are available, including analytical development and validation laboratory facilities, as well as the ICH-compliant stability programme.
QuaDPharma provides clinical supply management and research and development services for various dosage forms.
Formulation of semi-solids and liquids
QuaDPharma offers formulation capability of up to 1,000l and has fill and finish services for short and long-term commercial runs.
Primary containers such as bottles, jars, tubes, sprayers, single-use plastic ampoules and vials can be handled in the manufacturing facility.
The company provides additional value through its expertise in difficult formulations, including nano-emulsions and biologics.
QuaDPharma’s flexible manufacturing suites meet ISO: 8 and ISO: 7 standards to optimise a bioburden-reduced environment.
Solid dosage packaging
QuaDPharma has a high-speed, fully automated tablet and capsule blister packaging operation to serve clients’ clinical and commercial drug supply requirements.
Short-run semi-automated blister packing can be supported as QuaDPharma has short cycle times for supplying packaged drug products for clinical trial pack-outs / kitting and commercial manufacturing.
Customisable tooling allows QuaDPharma to adapt to the dynamic process clients go through when moving drug products through the commercialisation process.
QuaDPharma also operates a high-speed, full colour blister printer with a 100% automated visual inspection.
The company’s production areas and compliance systems support safe handling of cytotoxic finished solid dosage forms and provide an integrated set of manufacturing options.
QuaDPharma has a dedicated suite for short-run developmental aseptic liquid processing.
The company can formulate and fill liquids into vials and bottles within an environmentally controlled and monitored ISO: 5 (Grade A) space, which is optimised for manufacturing pre-clinical and early clinical drug supply.
Sterility assurance is supported through the maintenance of a robust environmental monitoring programme, United States Pharmacopeia (USP) and microbial bioburden testing. Sterility is ensured through a rigorous facility cleaning and disinfection programme.
Various types of filling, stopper and capping equipment can be set up for a client’s manufacturing campaign if required. All operators are qualified in aseptic techniques.
QuaDPharma was founded in 2010 as a unique platform for servicing small and large pharmaceutical clients with more collaboration and technical expertise.
The company’s personnel add value through project planning grounded in scientific processes and accurate risk management.