Swiss high potency active pharmaceutical ingredient (API) contractor Cerbios has broken ground on a building that will bring together its chemical and biological R&D departments.
The laboratories are being built in Lugano, southern Switzerland, Gabriel Haering, Cerbios CEO, told in-PharmaTechnologist.com.
Haering said the company’s old labs had become outdated and it wanted to makeover its R&D facilities to match the quality of its production laboratories.
Growth and personnel increases led shareholders to approve last year the construction, which is planned for completion in mid-2015.
Cerbios was also considering “possible future investments in additional production lines and consequent need of more people,” Haering told us.
Twice the R&D space
The new facility will house 6,240 sq ft of R&D space, as well as offices and a basement warehouse.
It will double the chemistry division’s laboratory space for highly potent active pharmaceutical ingredients (HPAPIs), which Cerbios handles up to Safebridge Category Four.
The biological R&D department will also double its laboratory surfaces, which are used for developing mAbs (monoclonal antibodies) and recombinant proteins from CHO (Chinese hamster ovary) mammalian cell lines.
Andrea Tam, the company’s new Chief Commercial Officer and Director of Business Development, oversees both the chemical and biological divisions.
Within the biologics division, the new plant will be used for developing and manufacturing “pharmaceutical probiotics,” said Haering.
The Lugano facility produces prescription and over-the-counter probiotics in the form of active pharmaceutical ingredients (APIs), intermediates, and finished products (in hard gelatine capsule form) for pharmaceutical clients and for its own line, based on Enterococcus faecium SF68.
“We are still launching our SF68 in new markets and working on new formulations for the established markets and new geographic areas subject to higher temperatures and humidity level,” said the CEO.
Cerbios is unusual in offering contract manufacturing of probiotics for pharmaceutical companies, claimed Haering, whereas there are many firms making probiotics for the food and nutritional industries.
“There are pharma companies developing new probiotics as therapeutic agents but they do not have the cGMP production capabilities for making them. You have to remember that these are living organisms and not classical active ingredients.”
Serbios’s SF68 product is produced for gastrointestinal therapies, Haering told us. The company’s external probiotic contracts target gynaecology and acne-focused dermatology, he said.