About Seratec NZ
Seratec NZ’s specialty is in the manufacture, purification and supply of polyclonal antibodies and other serum proteins for research use. Founded in 2012 by Chris O’Loughlin, BSc, MSc(Hons), dip Mol Med, the company has exported research use proteins and antibodies to a range of research institutions and resellers. Locally, we are a preferred supplier of antisera and standards for the New Zealand dairy industry and provide bulk serum filtration and consultation services to raw materials exporters of Bovine origin blood products.
Prior to 2012 Chris spent 18 years in commercial bio-pharmaceutical research beginning his career as a Research Associate under the late Professor Wayne B Watkins at the Professoral Unit, Dept of Obstetrics and Gynaecology, National Women’s Hospital, Auckland, NZ. Work involved developing pre-clinical ELISA assays for detecting pre eclampsia by identifying and quantifying the expression of markers including heat stable placental alkaline phosphatase in patients. In the late 1990s he worked alongside Professor Watkins in the early commercial pilot scale manufacturing and validation of a human use, caprine polyclonal anti HIV therapeutic for Watpa Enterprises Ltd. Chris has held positions of Assay Development Manager and Product Development Manager for Virionyx Corporation and Innate Immunotherapeutics Ltd, now Amplia Therapeutics Ltd (ASX, ATX) during FDA approved human trials of the polyclonal anti HIV drug HRG214 (HIV Reactive Gamma Globulin 214), or peptide enhanced PEHRG214, and the Secondary Progressive Multiple Sclerosis drug MIS416 (Microparticle Immune Stimulant 416) under Virionyx/Innate’s founding director and inventor, Dr Frank B Gelder.
Work at Virionyx Corporation and Innate Immunotherapeutics in Auckland, New Zealand centered around the GMP manufacture of the polyclonal antibody based anti HIV drug HRG214. This drug was administered under compassionate human trial use in AIDS afflicted individuals in NZ, and in FDA approved multi center clinical trial use in the U.S.A, and TGA approved trials in Australia. Chris was responsible for the development and manufacture of pharmacokinetics assays to quantify HRG214 drug levels in trial pateints and monitoring patients for potential antibody responses to the HIV Neutralising drug HRG214. He was also responsible for all antigen/vaccine conjugation chemistry and animal immunisations for the generation of the multiple anti HIV specificities required to formulate HRG214. As Product Development Manager, Chris was responsible for GMP based biological process and manufacturing validation. Work also included the manufacture of other research use antibodies against SARS, West Nile Virus, Anthrax, Pestis, Botulism, Hepatitis and other disease markers for collaborators.
During the early 2000s Virionyx Corporation and Innate Therapeutics used a proprietory microparticle adjuvant termed Induct315 to assist as a carrier molecule to present all antigens including those of peptide, lysate and recombinant orgin in all animal immunisations. This adjuvant assisted in the generation of high titer antibodies used in the manufacture of HRG214 and other research use antibody preparations. In 2009, Innate Immuotherapeutic's PE (peptide enhanced) HRG214 clinical trial program was ceased due to a lack of funds and a perception that competitor's newly FDA approved protease inhibiting drugs for the treatment of HIV infection would be a less expensive and easier to administer option for those individuals afflicted by HIV/AIDS infection.
Attention was subsequently focused on how Induct315 could be used as a therapeutic immune stimulant in humans. A slight change in the Induct315 manufacturing process, and subsequent NZ Medsafe GMP approval allowed for the first compassionate use trials of MIS416 on secondary progressive multiple sclerosis patients in New Zealand in 2009/10. With the development of MIS416 to successful clinical use, and the completion of animal toxicity studies in 2011, Chris left his role as Product Development Manager.
Seratec NZ have now amassed an extensive catalgoue of polyclonal antibodies and associated antigens to a range of disease markers including HIV, SARS coronavirus, West Nile Virus, Pestis, Anthrax and Botulism. The resultant polyclonal antibodies have been raised against combinations of viral lysates, recombinants, synthetic peptides and highly purified antigens all conjugated to a muramyl dipeptide like p. acnes bacterial cell wall extract adjuvant. Additional purifications including pepsin digested Fab fragments and antibody labelling services are available upon request.
Seratec NZ has provided contract bulk filtration expertise to the bovine serum supply industry, and endotoxin testing and assay development services to New Zealand based raw materials producers.
Seratec NZ is currently developing assay technologies surrounding the detection and quantification of milk proteins and the refining of manufacturing systems for the production of bacterial cell wall based microparticle adjuvants.