San Diego, US
Althea Technologies has launched a commercial-scale GMP manufacturing facility in Sorrento Valley area, a major biotechnology hub in San Diego, California. Althea Technologies is involved in contract development and manufacturing.
It offers services in the field of plasmid DNA, recombinant proteins and sterile products.
The new $15m facility was launched in April 2009 in response to the rising demand for outsourced manufacturing capacity, especially by San Diego-based drug and biotechnology companies that put a greater focus on R&D than production.
The facility has been designed to support the company’s rising demand in its drug product and biologics manufacturing business units.
The facility complies with the US and European manufacturing regulations. It received FDA approval to start commercial manufacturing in June 2011, following a pre-approval inspection in April 2011.
The facility is the third on Althea’s San Diego campus, bringing the total area occupied by the company on the site to 80,000ft2. The site has five GMP production suites, designed for the development of plasmid DNA, proteins and carrying out lyophilisation as well as vial and syringe filling for pre-clinical and clinical products.
The state-of-the-art facility spans 30,000ft2 and has been designed with flexible capacity. It accommodates laboratories for good laboratory practices (GLP) testing and separate suites for fully compliant GMP plasmid DNA and protein manufacturing and aseptic vial and syringe filling.
The laboratories have been designed for a host of gene quantification and expression services. Separate laboratories have been made available for biodistribution studies, adventitious virus testing and integration studies.
The facility also houses warehousing and materials management facilities. A custom design has been used to facilitate the movement of material and people and reduce the risk of cross-contamination.
Several airhandling systems and a water-for-injection water purification system have been installed. All production processes and unit operations can be scaled-up to commercially viable levels to support any future expansion.
The space dedicated for GMP production and fill / finish operations totals approximately 12,000ft2 (1,100m2). It houses a cellbanking production suite and four fermentation and purification suites equipped with microbial fermentors ranging in capacities from 30l, 100l to 1,000l.
There are six fill and finish suites, equipped with fully automated and semi-automated vial and syringe filling, inspection and labelling equipment and a formulation suite. The syringes vary in size between 0.5ml, 1ml long, 1ml and 20ml. The vial sizes range between 0.5ml and 100ml.
A new NOVA H3-5 high speed syringe filling line was installed within the facility in October 2010. The line operates under a restricted access barrier system (RABS) which enables handling of viscous products that require minimal head space.
The line accommodates nested syringes from different suppliers and is capable of generating batch sizes of more than 100,000 units. It began production of GMP batches in the first quarter of 2011. The syringes can be filled under vacuum.
The facility is equipped to undertake production from the pre-clinical development stage through to Phase III and commercial stage. It can develop recombinant proteins, plasmid DNA therapeutics and vaccines. It has been licensed to produce and package a commercial parenteral product for the US market.
The construction has been funded through multiple credit facilities. The company received $12m worth of credit facility from City National Bank, a wholly owned subsidiary of City National Corporation. The credit facility was used to finance the equipment for the facility.
Althea technologies also partnered with San Francisco based private equity company, Telegraph Hill Partners, for a $23m funding deal.
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