Tips on Buying Human Biologicals

Buying human biologicals for research purposes as well as having patent right to them has been accompanied by lots of ethical questions for as long as they have been used..

Human biological fluid research materials are also accompanied by another issue, who is the rightful owner of a particular human biological material?  Issues like this make it necessary for buyers to have information on when purchasing so that they do not fall prey to inadequate information that compromises valuable research.

What do we mean when we are discussing human biological research materials?  In section four of the Health Research Act it defines human biologics as parts of organs, cells, tissues or other components of any material sourced from a human being whether they are alive or dead.

Tip #1 – Understand the property rights that are common to the human biological you wish to purchase.

To know the right of ownership of any human biological materials (such as the human biological fluid research material) is essential because it will evade you from unnecessary legal injunctions.  This is particularly important when using materials in research.  The last thing that is needed when doing research is complications on the research materials that are used.

A standard reference to such issues is seen in the case of Doctor Fremont and Simon. Doctor Fremont applied for a patent right to Fremont’s DNA and got approved but there was no legal precision on ownership of the molecular pathology materials. For more information and details on this case take a look into “the taking of human biologicals”.

The point is this: before you apply for a patent or buy any human biological you should have adequate knowledge about the property right of such human biologicals. Just a hint here! For human biologicals such as human biological fluids materials, the legal position on it is that patents do not cover it when they are still in the human body, but when they are outside the human body, the patent holder can exercise an exclusive right to such materials.

Tip #1 – Understand the requirements of the particular human biological fluid research materials you want to purchase.

Human biological fluid research materials such as blood, serum and plasma have standard requirements for the buyer.  First, the blood will need to be stored in a refrigerator.  This is a standard requirement for you as a buyer.  Blood storage refrigeration is unlike traditional domestic refrigeration equipment.  The following refers to some specifications that are unique to a blood storage refrigerator.

• Must have an all round heavier insulation, which enables it to hold the required temperature in any case of power failure. With such insulin, it should be able to maintain temperatures between +2⁰ and +6⁰
• A blood storage refrigerator should have a cooling fan that enables it to distribute air in the cabinet evenly.
• It should have a good temperature monitoring device, which should comprise of an external temperature display and an alarm system for abnormal temperature or in the event of power failure.

In our next installment on buying human biological we will continue to look more in depth at the requirements of the particular human biological fluid research materials.

Learn more about Innovative Research and our high quality research materials including human, plant, and animal biological, ELISA & Assay Kits, proteins, antibodies, cell cultures, blood, serum, plasma, and more.  More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.

Animal biologicals include whole blood, plasma, serum, hormones, body fluid, glands, and tissues. The objective of collecting the biologicals is to ensure that they are free of every form of contamination. The principles that determine the collection of high-quality animal biologicals are determined by the animal source, the collection process and the storage of the products.

The animals in question should be antibiotic and anti-parasitic-free. The feed and water given to the animals must be certified to be free of any form of contamination. The animals should be healthy in every ramification, without merely the absence of disease. Sick or diseased animals should not be used as sources of biologicals. Any antibiotics to be administered to any animal should be certified by a veterinarian and must be given at least 21 days before the biologicals are collected. Antibiotic contamination limits the use of the biologicals and skews results. Parasitic contamination affects the integrity of tissue samples.

The samples should be collected when the animals are least stressful, as stress affects the quality of the samples. Sometimes, the biologicals have to be collected from genetically modified and pregnant animals for specific studies of such diseases as endocrine disease, diabetes, cancer and Alzheimer’s. The samples should be collected in the least painful manner. The conditions for the collection process must be aseptic in line with regulations for research. These regulations guide the restraint of the animals, the disinfection of the collection site, and the use of proper equipment. Collection sites should be shaved, and disinfected with 70% alcohol before and after the collection of blood.  New syringes should be used for each animal, and used syringes should be disposed immediately and appropriately. Biological products may be collected at abattoirs pre-slaughter or from donor animals on farms.

Blood is collected though a vacutainer and then transferred into vials, bottles or bags. It is more preferable to use a vacutainer instead of a syringe. To collect sera for serological analysis, no anti-coagulants are used. The blood sample should be made to stand at ambient temperatures for 1-2 hours. If the collection of whole blood is the goal, then the collecting receptacle would contain one of the following anti-coagulants: Sodium Heparin, Alsevers Solution, Sodium EDTA, or Sodium Citrate. The different anticoagulants have different properties and are suitable for different laboratory procedures. Whole blood samples should be transported to the laboratory at 4⁰C and not frozen.

Blood collection without fluid replacement is restricted to 10% of the total blood volume on a single occasion. Where blood collection would be regularly repeated, a canula may be used to reduce stress. At least 2.5ml and at most 10ml of blood should be collected per animal for an analysis.

Tissue harvest should be started immediately after euthanasia to prevent bacterial contamination through intestinal seepage. Organs should be observed in situ before tissue samples are removed. Tissues may be immediately fixed to prevent decay, autolysis and putrefaction, and thus preserve cells for examination. 10% buffered formalin is best for fixing tissues. The downside to preserving tissue with formalin is that it ruins the examination of the tissue for certain tests, such as microbial examination.  Alternatively, tissue may be refrigerated at 4⁰C for short periods or frozen at -10⁰C for longer periods.

Learn more about Innovative Research and our high quality research materials including human, plant, and animal biological, ELISA & Assay Kits, proteins, antibodies, cell cultures, blood, serum, plasma, and more.  More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.

Our ѕосіеtу is on thе brіnk оf dеvеlорmеnt and advancement where the word ‘advanced’ is thе tag for еvеrу ѕрhеrе оr field. There are various соntrіbutоrу factors fоr thіѕ аnd bіоlоgісаl рrоduсt іѕ one such fасtоr thаt demonstrates thе very аdvаnсеd ѕtаgе of our dеvеlорmеnt, аnd раrtісulаrlу, іn thе field оf science. Thеѕе рrоduсtѕ are used іn аlmоѕt all іmроrtаnt ѕесtоrѕ lіkе рhаrmасеutісаl іnduѕtrу, fооd іnduѕtrу, аgrісulturе, аnd оthеrѕ which аrе bесоmіng mоrе оr less a dаіlу nесеѕѕіtу.

Bіоlоgісаl рrоduсtѕ are thоѕе ѕubѕtаnсеѕ, obtained frоm lіvіng beings (humans, animals, plants, аnd mісrо-оrgаnіѕmѕ), whісh аrе uѕеd for prevention or fоr thе treatment of diseases. These рrоduсtѕ clone thе nаturаl аnd essential ѕubѕtаnсеѕ like hоrmоnеѕ, еnzуmеѕ, аnd antibodies in оur bоdу.

Examples оf biological рrоduсtѕ іnсludе:

• vaccines
• blood аnd blооd рrоduсtѕ fоr trаnѕfuѕіоn аnd/оr manufacturing іntо оthеr рrоduсtѕ
• аllеrgеnіс еxtrасtѕ, whісh аrе uѕеd for bоth dіаgnоѕіѕ аnd treatment (fоr example, allergy shots)
• humаn cells аnd tіѕѕuеѕ uѕеd fоr transplantation (fоr еxаmрlе, tеndоnѕ, lіgаmеntѕ, аnd bоnе)
• gene thеrаріеѕ
• сеllulаr thеrаріеѕ
• tеѕtѕ to ѕсrееn роtеntіаl blооd dоnоrѕ fоr infectious аgеntѕ ѕuсh аѕ HIV

Thеу аrе аlѕо саllеd ‘biologics’. These products іnсludе vассіnеѕ, blood аnd іtѕ рrоduсtѕ, аnаlоgоuѕ рrоduсtѕ, hormone еxtrасtѕ, toxin, аntіtоxіn, humаn cells аnd tissues uѕеd for transplantation, additives, lаbоrаtоrу chemicals, etc. It ѕhоuld also be nоtеd thаt thеѕе рrоduсtѕ, which can bе соmроѕеd of рrоtеіnѕ, ѕugаrѕ, nuсlеіс acids, еtс., аlѕо includes, рерtоnе, protein hydrolysates, уеаѕt еxtrасt, mаlt extract, lіvеr and bіlе еxtrасtѕ.

Bіоlоgісѕ еxрrеѕѕеd the hіghlу advanced nature оf mеdісаl ѕсіеnсе and research. There are consistent аnd соntіnuіng rеѕеаrсh еffоrtѕ for dеvеlоріng mоrе оf thеѕе products whісh will multірlу tо existing medication орtіоnѕ аnd to іntrоduсе a nеw treatment for thоѕе unаvаіlаblе оnеѕ.

Bіоtесhnоlоgісаl рrоduсtѕ are рrоduсtѕ which аrе рrоduсеd through biotechnology and uѕеd іn vаrіоuѕ fіеldѕ ѕuсh аѕ pharmaceutical, agriculture industries, veterinary аnd animal feed, cosmetic, fооd and bеvеrаgеѕ, microbiology сulturе mеdіа аnd рlаnt tіѕѕuе сulturе media, etc.

Biotechnology іѕ thе аррlісаtіоn of bіоlоgісаl рrосеѕѕ. Using the bіоlоgісаl еxtrасtѕ, thе tесhnоlоgу рrоduсеѕ a wіdе rаngе оf products fоr ѕеrіеѕ of рurроѕеѕ like nеw trеаtmеnt fоr dіѕеаѕеѕ, dеvеlоріng a nеw and аdvаnсеd kіnd оf сrорѕ, mісrо-оrgаnіѕmѕ thаt соnѕumе hаrmful organic wastes аnd оthеrѕ.

Amоng оthеr important contributions mаdе bу thіѕ technology, іѕ іn the fіеld оf food аnd bеvеrаgе, which іѕ outstanding. It рrоduсеѕ fооd additives and fооd ingredients іn order to рrоvіdе thе requіrеmеntѕ fоr production оf fооd. Thеѕе additives аnd food іngrеdіеnt products help іn рrеѕеrvіng аnd keeping thе processed food in gооd соndіtіоn fоr a long period оf time from thе mаnufасturіng ѕtаgе tо thе ѕеllіng ѕtаgе. Alѕо, these food аddіtіvеѕ аrе uѕеd fоr vаrіоuѕ рurроѕеѕ lіkе flаvоrіng and ѕеаѕоnіng оf fооd, рrеѕеrvаtіvеѕ, nutrіtіоn, meat рrоduсtѕ, еtс. and in іnduѕtrіеѕ lіkе саndу аnd confectionery, bаkеrу, сеrеаlѕ and dаіrу industries, аnd other fооd рrосеѕѕіng industries.

Learn more about Innovative Research and our high quality research materials including human, plant, and animal biological, ELISA & Assay Kits, proteins, antibodies, cell cultures, blood, serum, plasma, and more.  More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.

There’s no denying the value that quality human biological materials can provide to research, but with the increasing number of samples collected and stored every day the need to ensure the samples retain their level of quality is of paramount importance.

Further to that, there is an ethical responsibility to ensure that samples get used in a way that is most advantageous to society. Quality control systems need to be put in place at all stages, including collection, processing, and storage.

A detailed series of records and procedures applied to the samples will provide the information researchers need to understand how samples will be affected by the collection and storage methods. This process will also aid in determining the quality of the samples. The quality system allows researchers to determine if the human biological samples, such as plasma, remain fit for purpose.

Knowing what the samples are going to be used for plays a big part in how they are stored and collected. For instance, samples destined for use in human treatment will require a higher standard than samples collected primarily for research purposes.

A collection and storage system should not just outline how a sample is collected but also how it is transported, and any and all processes applied to it to facilitate the transport.

A biobank of tissue resources, where researchers have a large sample base to conduct research from, can have massive benefits for society.  However, varying standards in regards to quality and the data collected between facilities can mean that samples get lost or forgotten.

To minimize the impact this can have on sample quality and availability an independent body needs to have some input into how tissue samples are processed and managed. Two standards developed by the National Cancer Research Institute’s (NCRI) and Confederation of Cancer Biobanks (CCB) go a long way to ensuring the high quality of samples. They also use a high level of transparency in regards to their collection, storage, and use to increase public confidence.

Learn more about Innovative Research and our high quality research materials including human, plant, and animal biological, ELISA & Assay Kits, proteins, antibodies, cell cultures, blood, serum, plasma, and more.  More information can be found at https://www.innov-research.com/ or by calling 248.896.0145.