CDMO Idifarma has launched a service to deliver an accelerated path to clinic for molecules.
The service, called Simply to Clinic, uses the company’s expertise in oral standard and highly potent drugs to take projects from pre-formulation development through to clinical trial implementation, offering tailored services to develop, scale and manufacture product at the facility in Pamplona, Spain.
The service also aims to maximise yield and minimise waste of API and aims for a quick, reliable, on time and in full delivery of batches for clinical trial, the company claims, ensuring quality requirements that follow current GMP regulations.
"The technologies and expertise gained by Idifarma across its support of clinical trials of spray dried and oral solid dosage forms for more than 20 years provides the strong foundation needed for this service," said Idifarma’s Head of Site, Alfredo Gómez.
"Innovative products and clinical trials are often complicated because of timelines, regulations and the use of highly potent active substances. We truly believe that Simply to Clinic will provide many pharma companies with a quick and smooth entry into the challenging clinical program of new drugs. We are experienced in the problems commonly faced and will offer our integrated services to achieve a successful, timely and cost-effective outcome."
The 40,000 sqft facility in Spain is a partner for the development and GMP manufacture of niche, innovative, and highly potent drugs, with a particular focus in oral solids for oncology, and with capabilities such as spray-drying and formulation development.