San Diego, California, USA
NextPharma’s San Diego facility in California, USA, is a cGMP contract manufacturing facility serving companies in the biotechnology, medical device and pharmaceutical industries. It is FDA-certified for drugs and medical devices, as well as ISO-certified for medical device manufacturing.
The facility includes a fill / finish unit, a cold chain storage and logistics unit and a unit for medical device manufacturing. New clinical trial capabilities were added to the facility in October 2009.
NextPharma cGMP services
The NextPharma facility is custom-designed to accommodate a wide range of cGMP manufacturing services. Separate cGMP-compliant cleanroom suites are available for formulation and filling. Several cleanroom suites are housed within the aseptic area.
The suites include class 10,000 (class 7 or class C) formulation rooms and class 100 (class 5 or class A) filling rooms. The class 5 cleanrooms are installed with a 48ft2 hull lyophiliser that can accommodate 2ml vials to 100ml bottles and dry up to 6,500 5ml vials. The external condenser of the lyophiliser can sublime 45l of water.
The facility includes extensive suites for primary and secondary packaging as well as for labelling of clinical trial products. An exclusive suite is dedicated for secondary packaging of high-potency drugs. The suite is also used for primary packaging under inert gas conditions. Packaging of humidity-sensitive investigational medicinal products is conducted in a separate suite.
The facility also houses an extended, cold chain storage and logistics space that operates at controlled room temperatures and provides for distribution of products involved in phase I-IV clinical trials.
Temperatures at the validated and monitored cold chain storage area range between 15°C and 30°C, 2°C and 8°C, and -20°C and -80°C.
The manufacturing space for medical devices includes certified class 100,000 (class 8 or class D) suites. The suites can undertake custom bulk formulation and compounding for up to 1,250l.
The facility develops clinical products for the pre-clinical, phase I and phase II trials. Clinical products that contain biologics or small molecules in lyophilised, powdered semi-solid and liquid form are manually or semi-automatically filled into vials, bottles, IV bags, tubes and syringes under aseptic or non-aseptic conditions.
The size of the vials ranges between 2ml and 100ml. The size of bottles and bags ranges 2ml and 500ml, and 20ml and 500ml respectively. The syringes vary between 1ml and 20ml in size.
New clinical trial services such as randomisation, double-blinding, emergency letters generation, kitting and labelling, cold-chain storage, distribution, return and destruction of products used in phase I-phase IV trials, were added to the facility in 2009.
Analytical services offered at the facility include pre-formulation and formulation development, development and validation of analytical methods, release and stability testing, and compendial analysis. It involves small molecules, peptide, protein and oligonucleotide drug molecules in all dosage forms.
Medical device manufacturing at the facility involves clarifying or sterile filtration, liquid or powder filling, custom bulk and vials lyophilisation, labelling and packaging as well as kit assembly of diagnostics, medical devices, electronics and cosmetics. A range of logistics services including goods receipt, storage, administration of orders, processing of returns, picking, packing, shipping and dispatch of goods is also done at the facility.
The facility can fill and pack between 10 and 10,000 vials and between 100 and 10,000 syringes. Lot sizes for lyophilisation and finishing depends on the configuration of vials. Standard vial configuration used at the facility is 10,800 vials at 2ml and 1,120 vials at 100ml.
Outsourcing: Advantar Laboratories
The San Diego facility outsources its analytical services to Advantar Laboratories as part of a strategic agreement entered into in 2009. Advantar Laboratories, a contract product development services provider for the biotechnology and pharmaceutical industries, operates a large laboratory suite at San Diego.
Under the agreement, the San Diego facility also provides aseptic and non-aseptic fill and finish services to Advantar customers.
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