SYNBIOS® SYNTHETIC PROTEIN-FREE MEDIA ELIMINATES DISEASE TRANSMISSION

The SYNBIOS®MEDIA core technologies are novel synthetic and chemically defined formulations of protein-free culture, handling and cryopreservation media. Their clinical efficacy has been proven. Please click on efficacy for more information.

The SYNBIOS®MEDIA technologies are created for Assisted Reproduction and Stem Cell Technologies (ART & SCT) for application in human healthcare, meat and dairy industries.

In human ART procedures conventional gamete and embryo culture, handling and cryopreservation media utilize donor serum protein supplements, which carry a theoretical risk of disease transmission through protein-bound pathogenic agents. In 1998 a human donor of serum proteins used in IVF media production died of Creutzfeldt-Jakob, or “Mad Cow”, disease. Past reports have documented IVF patients were infected with hepatitis due to contaminated protein supplements used in media preparation. The use of synthetic media eradicates this danger of disease transmission.

Likewise in animal assisted reproduction, bovine serum (BS) and bovine serum albumin (BSA) used in gamete and embryo culture, handling and cryopreservation media could  transmit protein-bound pathogenic agents. It is well recognized proteins cannot be sterilized with complete certainty. The BS and BSA are extracted from cattle blood. Cattle is host to over 1000 viruses, which can be transmitted to other animals or even jump host from cattle to the human. In addition, BS and BSA could also be a source of prions that transmit mad cow disease.  Prions of mad cow disease cannot be destroyed by extreme heat. The meat and dairy industries have witnessed epidemics of devastating transmissible diseases in the past. The critical need for synthetic gamete and embryo culture, handling and cryopreservation media in preventing disease transmission in the meat and dairy industries is readily apparent.

The synthetic nature of the SYNBIOS®MEDIA products which are devoid  of added serum proteins makes it among the safest media on offer for both human and animal application.

SYNBIOS®MEDIA also offers equally efficacious protein-supplemented gamete and embryo media for clients who prefer to use culture, handling and cryopreservation media that contain serum proteins for both human and animal application.

The SYNBIOS®MEDIA enables the culture and handling of pre-implantation embryos/gametes in the total absence of donor proteins and/ or peptides; beginning from insemination, followed by fertilization and thence all the way to the hatched blastocyst stage.

Extensive and systematic scientific research led to the development of these technologies. These investigations were painstakingly undertaken for over a period of 30-35 years to achieve the challenging objective of creating a series of safe and efficacious synthetic protein-free media products which eliminate the risk of disease transmission.

All SYNBIOS® products are the outcome of thorough research performed to ensure safety and efficacy. We are thorough in our research and our research findings are conclusive.

As an illustration the research design for the development of our VS14 vitrification solution was systematic and extensive. It investigated 3,044 cryoprotectants and 6,088 permutations.

The VS14 vitrification solution was found to be the only promising, least toxic and most efficacious cryoprotectant combination out of 3,044 cryoprotectant solutions and 6,088 permutations investigated.

A number (n=5) of synthetic embryo culture media were formulated in the early 1990’s (Dec 1989- Oct 1992) by SYNBIOS®. Historically, the first synthetic embryo culture media that we communicated in the scientific literature was the ART-7b media series which proved highly effective for cleavage-stage embryos (1997-2004) with excellent clinical outcome (see “Efficacy” page). However, ART-7b did not support development of blastocysts. It was phased out in 2004.

Around 2005 another formulation of the synthetic culture media series called PFM-11 was earmarked for commercialization. It was basically formulated for cleavage-stage embryos but some workers reported that it supported development of blastocyst-stage embryos, albeit slowly. PFM-11 was licensed to Cellcura ASA of Norway (July 2005).  IVF/ICSI pregnancy rates were comparable to that reported for other contemporary culture media. Whereas IUI pregnancies obtained with the use of synthetic medium were about double  that reported worldwide. The PFM-11 media license agreement with Cellcura was terminated/discontinued in 2014. The PFM-11 media series was subsequently phased out in the same year.

Another formulation that was previously formulated between 1989-1992 was Trade Mark-registered SYNBIOS®MEDIA in 2015. In subsequent years (2016-2018) it was custom-manufactured in Europe under a contract-manufacturing agreement (2016). Of interest to the ART profession is that the performance of the SYNBIOS® synthetic embryo culture medium in generating blastocysts is comparable to that of contemporary commercial protein-supplemented embryo culture media.

Blood and blood products are considered impure/unclean in many cultures (eg: Surah 2:173;5:3;6:145). The SYNBIOS® embryo culture media products are devoid of donor blood proteins. It is anticipated to comply with the cultural norms and lifestyle of many religions and beliefs. The SYNBIOS® culture media appears compliant with the values of various communities. The SYNBIOS® human embryo culture media formulation has previously been certified Halal-compliant by the EU Halal authority.

While assisted reproduction technology (ART) is acceptable in many cultures however minor  but critical variations exists between individual cultures. For instance while mainstream Islam permits ART but third party involvement in reproduction is not permitted which means gamete donation and surrogacy is not permitted and is considered a taboo.

The purity of the lineage of the progeny is paramount in a number of cultures. This also means that any procedure or protocol in the ART treatment that could allow crossover of genetic material between the embryonic genome and donor (third party) DNA/RNA likewise is not permissible.

The synthetic SYNBIOS®MEDIA products does not contain donor DNA/RNA because it is devoid of donor serum proteins. This attribute eliminates the risk of crossover of the embryonic genome with third party genetic material ensuring that embryos generated during ART treatment retain their two-parent genetic constitution thereby preserving the purity of lineage of the progeny.

The SYNBIOS® synthetic protein-free embryo culture media can be frozen-stored for up to 24 months without loss of efficacy. Freezing enables longer shelf life making SYNBIOS® embryo culture media less wasteful and economical.

SYNBIOS® now offer you quality efficacious synthetic protein-free and conventional protein-containing media. These media are the products of relentless research effort of close to three decades of dedication and perseverance. We hope you will find them efficacious, safe, economical and useful. We wish you success with SYNBIOS® products.