Products

Bacterial fermentation of natural Streptococcus, safe non-GMO strain.
Alternative source of high molecular weight HA from cocks comb.
Naturally occurring polymer under REACH regulation

A safe raw material

with a safe Streptococcus equi strain.

Streptococcus strains are widely used for many years to produce sodium hyaluronate (EP monograph 1472). Streptococcus equi chosen by HTL is a natural strain and non-genetically modified (non-GMO). This Gram positive strain does not produce endotoxins outside the cell. It does not produce hyaluronidase, DNase, streptokinase, erythrogenic toxin, hemolysin and any other toxin or immunogenic contaminant that may be found in the culture medium at the same time as sodium hyaluronate. Absence of hyaluronidase activity explains the ability of this strain to produce very high molecular weight HA (up to 5000 kDa). Culture supernatants have been injected to the Swiss mice (IP injections): no mortality and no physiologic perturbation have been observed. The strain is non pathogen for Human. Several million doses of HA, produced by Streptococcus equi, have been injected in human and veterinary medicine for over 20 years and have shown their tolerance and safety regarding human and veterinary health. This high level of security will not be reached today with GMO-obtained HA, that does not have the same history on the market. Regarding REACH regulation, HA produced by a natural strain is considered as a “naturally occurring polymer” and is exempted of registration which is not the case for GMO obtained polymers.

 

with a best class purification

. no animal-derived materials are used for the HA manufacture, from the Master Cell Bank (MCB) conservation to the ingredients used in purification steps,

. produced with a high quality of starting materials (pharmaceutical quality, starting materials from sustainable agriculture source, highly purified water, bio-ethanol…)

. produced under GMP conditions, with validated manufacturing processes. HTL is regularly inspected by European and US health authorities

. strictly controlled according to HA EP monograph and validated analytical methods

. contains very low level of impurities including proteins, bacterial endotoxins…

 

To maintain very high molecular weight during the purification steps, HTL uses gentle techniques including slowly mixing and pumping, ethanol precipitation, and vacuum drying. Bio-ethanol, recycled in HTL plant, is a safe solvent (ICH, class 3) usually used for Drugs. According to “residual solvent” regulation, the level of ethanol on HA is very low and regularly controlled.