Biotest Laboratories Pty Ltd (Biotest)

 

 

 

 

Biotest was established in 1989 to provide expert scientific services to food, pharmaceutical and biological manufacturers.

Biotest believe its sucess is based on strong service delivery, oustanding people and knowledge of the technical and regulatory challenges facing manufacturers.

We believe our broad customer base and 100's of contract arrangements with clients with many enduring relationships, attests to our performance.

Biotest offers analytical chemical and microbiological testing services, cGMP auditing, consulting and training services.  Through our Clean room facility we provide cGMP production of biologicals including stem cells.

Analytical Testing Services - Our laboratories are TGA licensed (licence No.524) and APVMA licensed (Licence No. 6036 ) and NATA accredited analytical laboratory offering high level testing services and contract manufacturing services applicable to biological products, including cGMP manufacture, sterility, BP chemistry, LAL pyrogen and cell toxicity studies.

cGMP Auditing, Consulting and Training - Biotest have qualified and experienced auditors and trainers able to support manufacturers.  Biotest have helped manufacturers in the review and development of SOP's, validations, process improvements and regulatory submissions.

With Over 25 years expeprience, Biotest has in excess of 35 staff actively employed in the delivery of scientific sercives in microbiological, chemical and biological testing areas providing for the control of raw materials, inprocess QC and finished product monitoring.

Biotest laboratory Brisbane

 

cGMP Manufacture

 

 

 

 NiomicGMP Production

Biotest have an APVMA cGMP licence (1089) for the manufacture of "Autologous Equine Mesenchymal Stem Cells from Bone Marrow".  Biotest have dedicated cleanroom facilities, cell incubators, microscopes, Class II hepa filters and refrigerated centriffuges supporting cGMP stem cell production.

With a 240l PLV and controlled rate freezer, Biotest provide a validated cryopreservation and cell storage system.

Relevant testing includes:

Product Bioburden, Cell Contamination, Cell viability, LAL Pyrogen, Near Infrared screening of raw materials, Cell Phenotype (staining & Cell flowcytometry).