GenWay's Core Compentencies:
As a protein and antibody solutions provider, GenWay has a multi-functional technology platform specialized in using genes, proteins, antibodies, and their applications in cells, tissues and animal models, for functional genomics and proteomics. GenWay’s core competencies enable the Company to carry out bioinformatic analyses of protein targets, produce high-quality protein antigens and ligands, and develop domain-specific IgY antibodies for immunoaffinity capture, partitioning, detection and analyses. The Company can also provide downstream proteomic analyses, target validation, and diagnostic product development.
The GenWay Facility:
GenWay’s headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area. The corporate facility is a 12,000 ft two story building, equipped with state-of-the-art systems and equipment for our operations.
The laboratory and manufacturing space is 6,000 sq. ft. equipped with all appropriate safety equipment.
The laboratory area is adjacent to manufacturing and is designed to support several departments including: analytical, molecular biology, virology, cell biology, process development and viral clearance. State of the art equipment specific to each discipline is found in each of the laboratories. Custom protocols/methods are routinely developed on a project basis in collaboration with the customer. Process development uses equivalent upstream and downstream equipment platforms enabling highly efficient technology transfer to production operations that are substantially in compliance with GMP standards.
GenWay maintains an extensive equipment program. Periodic calibration is performed by certified companies. There are written procedures for control, calibration, validation, cleaning and preventive maintenance of all equipment. Equipment used for GLP and GMP services is calibrated and 24-hour alarm-monitored. IQ, OQ and PQ procedures are performed where appropriate on equipment to ensure that specified operational requirements are met and equipment instructions for use are available. Calibration and equipment record manuals are kept current and testing of equipment is conducted using nationally or internationally established standards. Equipment calibration/testing schedules are maintained and updated regularly. A sticker labeling system is employed to identify the last calibration and maintenance date or if equipment is designated for non-use due to performance or mechanical issues. Equipment is cleaned according to corresponding SOPs on a regular basis, and such cleaning is documented.
Flow hoods are validated and certified on a regular basis by a certified company. Accurate records of hood validation and certification are kept on the premises.
Air quality is maintained by having 15 air changes/hr, and air filters are changed monthly.
Production areas are currently separated at GenWay. There are separate enclosed areas for eukaryotic and prokaryotic manufacturing. These areas are separated by a distance of 60 feet.
There is restricted access to the production areas. Every visitor has to be accompanied by GenWay staff. There is a sign-in procedure before entrance to the premises.
Temperature control is maintained in the production areas.
Pest control is performed on an annual basis by a professional contractor.
The Company has a designated Safety Officer, who administers the Safety Program, including training, SOPs, inspections, etc. GenWay is inspected by the San Diego Fire Department annually, and there is a written Bio-Hazardous materials Plan.
There is a written contract that details the specific tasks involved in cleaning the entire facility twice a week. The cleaning crew fills out a checklist at the end of each cleaning visit, documenting the cleaning performed, and the work of the cleaning crew is periodically inspected.
Handling one Product at a Time:
GenWay produces only one product at a time, in accordance with GMP Standards.
Hygiene and Health Control:
The following hygiene/health control systems are in place:
- First Aid kits/stations
- Emergency eye-wash/emergency shower
- Mandatory lab coat dressing
- Mandatory safety goggle use
The following training is conducted on a regular schedule:
- Lab staff procedural training
- Safety training
- QC/QA training, including analytical methods training
- GMP training, including SOP training
Hands-on training is performed using training documents that are exact copies of protocols, SOPs or Master Batch Records, to ensure training is consistent with the test procedure. At the conclusion of training, an assessment is made by the Laboratory Manager, Trainer and Trainee as to whether or not laboratory personnel are qualified to perform testing on the client’s test articles.