Introducing an Optimized Process Management Concept from Drug Development to Drug Manufacturability: Advaceutics®

Reducing risk, defining time lines and increasing cost efficiency on a new drug’s way to commercial scale manufacturing.

Martinsried, Germany, August 26, 2011 --( ProJect Pharmaceutics (PJP),, who started operations last year, introduces its innovative approach Advaceutics® to balance the know-how between formulation science, pharmaceutical process development and drug delivery technologies efficiently. Advaceutics ® – a combination of the terms advantage and pharmaceutics – ensures seamless and integrated process management during all required steps that transform proteins, peptides and delicate small molecules into a manufacturable drug. Optimized and tailor-made solutions developed under the Advaceutics ® regime reflect PJP’s holistic approach, encompassing all vital aspects such as safety, stability and cost-effective manufacturing, in order to ensure that the process may be transferred smoothly to large scale GMP manufacturing at a later stage.

Advaceutics is PJP’s overall modus operandi safeguarding client projects and, in short, comprises the following steps:

· defining the best pharmaceutical strategy for a perfect drug presentation by offering thorough consulting
· applying innovative, science-based technologies to stabilize the native 3D structure of proteins most effectively and reliably throughout the entire shelf life
· developing innovative depot formulations and drug delivery systems for optimized pharmaceutical action
· identifying the ideal packaging system and delivery device for the drug formulation considering convenience, safety and stability aspects
· developing reliable and cost-effective manufacturing processes for the pharmaceutical system
· selecting and qualifying the most suitable CMO for the pharmaceutical system and transferring the technology into large-scale GMP manufacturing

As time-to-market, risk reduction and production costs influence the overall success of the new product heavily, the best time to optimize these key factors of success are actually the very early planning and development stages of the process during which various options are still under consideration. In times of increasing globalization and a constantly changing pharmaceutical value chain, capital efficiency in developing new drugs, paired with profound expertise and highly reliable quality of outsourced services, are ever important for competitive pharmaceutical companies facing a challenging market environment. To meet this client demand, ProJect Pharmaceutics developed a unique process to plan, control and audit its highly complex service at all times, thus making it as transparent as possible with regards to risk reduction, time line definition and cost efficiency.

ProJect Pharmaceutics GmbH
Klaus Hellerbrand
+49 (0) 89 452289700