BIOTEM, a hybrid Contract Research Organisation (CRO) and Contract Manufacturing Organisation (CMO) focusing on high added-value services in the development/production of custom monoclonal antibodies and immunoassays, has announced the implementation of a new industrial site in Colombe, Isère.
This new site will be fully dedicated to immunoassay production, which will enable BIOTEM to improve the quality and quantity of its offering to meet the requirements of the In Vitro Diagnostic Medical Devices (IVDMD) market.
The new 900 m2 facility will complement the company’s 2000 m2 of antibody production platform already in operation. It will focus specifically on ELISA (Enzyme Linked ImmunoSorbent Assay) and LFIA (Lateral Flow ImmunoAssay) tests, manufacturing them to the highest current standards.
The site will be equipped with humidity-controlled dry rooms, an ISO 5 standard room (equivalent to a cleanroom), a biosafety 2 confinement laboratory, cold storage, packaging and assembly facilities, and warehousing. BIOTEM’s boosted capacity will allow it to meet the demand for immunoassays, which has been growing rapidly, particularly against the backdrop of the healthcare situation of recent years.
The company has benefited from a €300k ($314k) grant awarded by the French government as part of its France Relance economic initiative.
Together with two loans from its historic banking partners (BNP Paribas and Crédit Agricole Centre-Est), this grant will support BIOTEM in strengthening its position as a domestic producer of biological tests and help to reduce the country’s/ dependence on suppliers that are either physically or strategically distant, the importance of which was put in stark relief by the COVID-19 pandemic.
With this boost to its capacity, BIOTEM has upped its projections and now expects growth of 20–30% during the next 3–5 years. Alongside these developments, the company is planning to step up recruitment by hiring around 20 new staff in the coming months and intends to double the size of its immunoassay team.
BIOTEM is seeking to consolidate its quality assurance and regulatory divisions to extend the scope of support it can offer its customers.
“We’re delighted to be able to provide a better immunoassay offering to our clients. This additional infrastructure will allow us to meet more stringent quality requirements in the field of IVDMDs while retaining our flexibility,” explained Clarence Deffaud, comanager and CSO at BIOTEM.
“Our ambition has always been to provide a quick and efficient response to the requirements of the international market. These new facilities will enable us to further stake our position within the sector. We are also planning to deepen our partnerships with large groups within the human health, veterinary and environmental sectors.”
