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BioPharma

There are several active compounds that are naturally produced by microorganisms. Modified versions of these microorganisms are now essential in modern day pharmaceutical production.

Active Pharmaceutical Ingredients (APIs) can be produced by these microorganisms using applied biotechnology. Gnosis is able to manufacture several APIs in large scale through biofermentation and to modify the structure of natural metabolites obtained by synthesis and semisynthesis.

Saccharomyces boulardii is a very well-researched probiotic yeast, which has been extensively examined with more than several hundred studies, and has been recognized as antidiarrhoeals, intestinal anti-inflammatory and anti-infective agent.

The clinical activity of S. boulardii is particularly relevant in prophylaxis and treatment of intestinal dismicrobism induced by antibiotic and sulphonamides (and disvitaminosis from them), therapy of acute diarrhoea of varied etiology such as prophylaxis and in treatment of “traveler's diarrhoea", in therapy of irritable bowel syndrome and in treatment of candidiasis of the intestinal tract.

Studies have also shown it may support gut function on conditions, including food allergies, parasites, Crohn's disease, HIV diarrhoea and Pseudomonas, intestinal infections, including Clostridium difficile and Cholera. S. boulardii is available also for veterinary applications.

Technical information

ATC Code “Antidiarrheal microorganisms”: A07FA02
Product Grade: Oral Grade

SAMe is a biological compound found in every living cell of the human body, vital to their function, stability and activity and involved in more than one hundred biochemical reactions and specific processes.

SAMe has been extensively studied since the first description of its chemical structure by Dr. Cantoni back in 1952. Decades of research on the biochemical and molecular roles of SAMe in cellular metabolism have provided an extensive basis for its therapeutic use in clinical studies, including those on depression, dementia, liver disease, joint health an osteoarthritis.

Gnosis is a worldwide leader in SAMe production by fermentation. This leading position is underpinned by more than 30 years of experience collected in the manufacturing of SAMe for the pharmaceutical, nutritional and veterinary markets.

Technical information

AATC Code "Alimentary Tract and Metabolism": A16AA02
CAS Number: 29908-03-0
Product Grade: Oral Grade; Injectable Grade, for use in Sterile Parenteral Product

This endogenous tripeptide (glycine, cysteine and glutamic acid) is present in almost all cells of the body playing a key role in the detoxification and excretion of drugs and xenobiotics.

Glutathione is used in injectable form, for therapies related to ethyl alcohol or drug intoxication (anti-neoplastic chemotherapy, anti-tuberculosis, neuroleptics, anti-depression and paracetamol, acting as antidote for poison). It may also assist in prophylaxis and treatment of the damages from ionizing radiation.

Technical information

ATC Code “Antidotes”: V03AB32
CAS Number: 70-18-8
Product Grade: Injectable Grade, for use in Sterile Parenteral Product

Teicoplanin is a glycopeptide antiobiotic complex isolated from the fermentation broth of Actinoplanes teichomyceticus, used in the prophylaxis and treatment of serious infections caused by Gram-positive bacteria, such as staphylococci, streptococci, enterococci, bacilli and diphtheroids and including methicillin-resistant Staphylococcus aureus and Enterococcus faecalis.

Indication
Teicoplanin owns a molecular structure correlated to that of vancomycin with similar spectrum of activity. Its mechanism of action is to inhibit peptidoglycan polymerization, that results in consequent inhibition of Gram-positive bacteria cell walls synthesis and consequent cell death. Teicoplanin is clinically and bacteriologically effective against a wide variety of Gram-positive infections such as septicaemia, endocarditis, skin and soft tissue infections and infections associated with venous catheters. The drug is used in patients who cannot receive or fail to respond to the penicillins or cephalosporins.

Application
Due to its reduced rate of side effects not requiring a close monitoring, its longer serum half-life and a simplified mode of application, teicoplanin is a valuable alternative to vancomycin and has become the glycopeptide of choice in many hospitals. The exceptional long half-life allows its once-daily intramuscular or intravenous administration. Oral teicoplanin has been demonstrated to be effective in the treatment of pseudomembranous colitis and Clostridium difficile-associated diarrhoea, with efficacy comparable to that of vancomycin.

Technical information

ATC Code "Glycopeptides antibacterials": J01XA02
CAS Number: 61036-62-2
Product grades: API not Sterile, for use in Sterile Parenteral Product; Injectable grade API, Sterile API

Daptomycin is a natural cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. It is a bactericidal antibiotic selectively active against aerobic, facultative, and anaerobic Gram-positive bacteria. Daptomycin is inherently inactive against Gram-negative bacteria as they have an outer membrane that the drug is incapable to penetrate and they lack specific factors essential for its activity.

Indication
Daptomycin has clinical utility in the treatment of infections caused by aerobic, Gram-positive bacteria, with equal efficacy to that of semisynthetic penicillins or vancomycin. Daptomycin is the drug of choice for empirical antibiotic therapy of staphylococcal endocarditis due to its optimal activity against both meticillin-susceptible Staphylococcus aureus and meticillin-resistant S. aureus (MRSA) strains. It is clinically and bacteriologically effective against Staphylococcus aureus bloodstream infections (bacteremia), complicated skin and skin structure infections (cSSSI), and it is used in patients who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy).

Application
Daptomycin retains potency against antibiotic-resistant Gram-positive bacteria, including isolates resistant to methicillin, vancomycin, and linezolid. Daptomycin is poorly absorbed orally and should only be administered intravenously. Intramuscular injection is prohibited as it causes direct toxicity.

Technical information

ATC Code "Other antibacterials": J01XX09
CAS Number: 103060-53-3
Product grades: API not Sterile, for use in Sterile Parenteral Product; Injectable grade API

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement.

Gnosis has integrated its expertise in APIs production by fermentation with advanced know-how on chemical synthesis and thus is able to offer development and production services for semi synthetic drugs, including antibiotics.

Operating units are strictly integrated in a multi-purpose FDA-approved manufacturing facility, where efficient process design and technology transfer are carried out according to cGMP standards and in compliance with a strict quality system.

BL2 - GMO The modular structure of the facility can accommodate different process flow models and is approved for handling BL2 and GMO microorganisms. With proprietary bioprocesses for the production of biotherapeutic molecules, Gnosis is well-suited to participate in partnerships and customized collaborations, proposing process and product development services as well as tailor-made industrial production solutions.