The new pharmaceutical service provider said its aims is to help client’s successfully transfer products from the pilot lab into large scale GMP manufacturing without the risk of defective batches thorough its service offerings.
Based on its ‘Advaceutics’ concept, ProJect Pharmaceutics (PJP) claims it can add value to clients’ bio-therapeutic products using state-of-the-art analytical methods, science-based formulation design and tailor-made drug delivery systems.
“Advaceutics ensures that customers receive tailor-made solutions for their recombinant and synthetic polypeptides,” managing director and founder of PJP Andreas Schütz told Outsourcing-Pharma.
Explaining that the service is targeted towards small and mid-sized biotech companies looking to outsource responsibility for the pharmaceutical and technical aspects of their projects, Schütz said Advaceutics comprises of several services which will be offered out of the new facility.
As part of the package, the firm promises it will design safe and convenient formulations and drug delivery systems as well as identifying packaging systems and delivery devices and developing reliable and cost-effective manufacturing processes.
Furthermore, the firm offers to select and qualify suitable contract manufacturing organisations (CMOs) for the pharmaceutical system, leading to the eventual “smooth transfer” of the technology into large scale GMP manufacturing.
Schütz claimed PJP’s Advaceutics provides “a holistic approach, which integrates the marketing aspect of a safe and convenient drug presentation, science based stabilisation technologies for long term stability of therapeutic proteins and economic aspects for the optimised and cost-effective manufacturing of the drug.”
State-of-the art labs
The new facility, located in the biotech cluster in Martinsried, comprises of analytical labs, equipped with analytical instrumentation used to characterise therapeutic proteins and protein drug products, such as chromatography, spectroscopy, and electrophoresis, as well as a pilot lab, equipped with process technologies used in commercial aseptic manufacturing of drug products.
While the PJP started out with six employees, the firm said it expects to “expand significantly” next year as Schütz is “strongly convinced” PJP’s services are growing in demand in the industry.