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Nov 03

SFN

Nov 03, 2018

San Diego, CA, USA

          

MP Biomedicals New Zealand Limited   

 

                  

A specialized manufacturer of high quality biological products, MP Biomedicals New Zealand Limited has gained an international reputation in providing bovine plasma proteins such as Bovine Serum Albumin (BSA), Transferrin, Fibrinogen, Thrombin, and IgG to bio-pharmaceutical, animal health and diagnostics industries.  New Zealand sourced bovine plasma coupled with an ISO 9001 and cGMP audited quality system, that are further endorsed by EDQM TSE Certificates of Suitability (CEP) for key products, aim at the highest product quality standard in the bovine blood plasma industry. 

 

Quality Assurance

 Quality is an integral part of every step of MP Biomedicals New Zealand’s operations – right from sourcing of raw materials to the manufacture of finished product ready to leave the site.

All products are manufactured using New Zealand sourced raw materials. The European Food Safety Authority (EFSA) publishes a Geographical BSA-Risk Assessment (GBR), in which New Zealand is classified as Negligible BSE Risk, the lowest category possible. No BSE or List A animal diseases are present in the raw materials that we use.

MP Biomedicals has an ISO 9001 certification, and its Quality Systems are audited to cGMP standards. MP Biomedicals are also an Approved Exporter and have a Risk Management Programme (RMP/HACCP) in place, approved by New Zealand’s Ministry of Primary Industries (MPI). This gives customers the assurance of complete traceability of the products that MP Biomedicals supply.

Documentation standards at MP Biomedicals are of the highest order and can cater to the exacting standards that are often sought by the pharmaceutical industry, which operates in a highly regulated environment.

 

State of the Art Chromatographic Technique

MP Biomedicals New Zealand uses the chromatographic technique for separation and purification of its proteins, as opposed to the traditional methods of cold ethanol (Cohn) fractionation and BSA stabilised heat shock. This technologically advanced process leaves the protein molecules fully intact, and in turn leads to a higher cell culture and cell expression performance in the bio-processing applications for our customers. Higher performances in cell growth and production titres result in substantial savings in terms of time and process efficiencies, thereby leading to lower costs.

 

Minimal Risk

 As a manufacturer of the highest quality of bovine plasma proteins for the global market, MP Biomedicals New Zealand minimizes your risks due to the following factors:

  • Bovine Plasma sourced only from within New Zealand, which has a negligible BSE risk status
  • State of the art chromatographic extraction ensures high purity, intact proteins, processed without the compromising effect of traditional methods.
  • Assured and secure supply chain
  • An ISO 9001 certificate, and a Quality System audited to cGMP principles, ensure the highest level of process control and consistent product quality.
  • Ministry of Primary Industries (MPI) approved manufacturing facility that ensures complete traceability.
  • Highly flexible operations to enable better product mix and customized product offerings

 

 

Uncompromised Reliability, Tangible Benefits, Minimum Risk