Its Brisbane-based research laboratory will build on its existing probiotics-making expertise with CSL Centro Sperimentale del Latte to provide manufacturing support for supplements, pharmaceutical and biotechnology companies with biotherapeutic products.
Sacco System currently has two production sites with drug GMP certification and states the Australian facility is “seamlessly integrated into the fully-automated GMP production facilities in Italy, that is supported by state-of-the-art analytics”. It also touts the ability to manufacture up to 20,000L batches in GMP.
Its business development director for Microbial Therapeutics, Dr. Max Rossetto, revealed to NutraIngredients-Asia on why Australia was considered for the facility:
“Australia’s pragmatic yet highly scientific approach to early phase clinical trials, favourable taxation system and excellent scientific base has been the reason why the CRO and CMO industry has been flourishing in the last few years. As part of its worldwide expansion, Sacco System has decided to invest in Australia by creating a new development laboratory in Brisbane.”
On its work with the Australian regulators in setting up the facility, Rossetto explained: “The Australian Therapeutic Goods Administration (TGA) and Food Standards Australia and New Zealand (FSANZ) control the use of probiotics in therapeutic and food products within Australia. Legislation in both regulatory bodies allows for new bacteria approval.
“Selected bacteria are already allowed in medicines governed by the TGA or foods regulated by FSANZ, but not all of them. However, we have systems and processes are in place which allow this to occur, and our team helps clients navigate these based on their specific needs.”
Rossetto also discussed Sacco System’s plans to upscale its expansion in the region: “Our investment in the Australia-based development laboratory to develop efficient fermentation protocols for customers’ strains is an example of how the [APAC] region is seen as crucial to the future expansion for our company. Sacco System wants to continue expanding our presence in APAC.”
Dual offering to support microbial therapeutics development
Known as the “microbiome offer”, the Australian facility offers active ingredients and services to companies developing probiotics, postbiotics and microbial therapeutics.
Rossetto added that its active ingredients have been categorised into the Culture Science and Culture Select portfolios - the former with clinically proven, readily made formulations and the other allows for the flexibility to create unique formulations.
Its probiotics are offered as either single strains, or a pre-formulated and customised blend.
Some probiotics in its Culture Science portfolio include probiotics for intestinal health, oral health, skin health and more; while its Culture Select portfolio include Bi1 - Bifidobacterium animalis subsp. Lactis, BLC1 - Bifidobacterium animalis subsp. Lactis, SP 9 - Bifidobacterium bifidum and more.
Sacco System’s customised services allow companies to bring their bacterial strains to the Australian facility for commercial GMP production, and the strains worked on will be kept confidential and remained in ownership by the companies.
Microbial therapeutics growth potential
There has been increasing focus on the use of microbes in therapeutics.
NutraIngredients recently published an international review highlighting the effectiveness of postbiotics, and covered another biotech’s venture in the use of microbiomes in areas of immune health, allergies and cancer care.
“This situation [of widespread prevalence of non-communicable diseases] has progressively led to a surge in the importance attributed to microbes in the field of human health and diseases. By combining non-pathogenic bacteria into living biotherapeutics, made up of synthetic microbes, a new study has revealed the possibilities of building live biotherapeutics to address specific disease pathways.
“Considering the ever-rising numbers of the global population, and the concurrent spread of numerous lifestyle disorders, emerging economies will foreseeably emerge as potential opportunity centres for these new applications,” Sacco System added in a statement.