EuroBioTechNews: From development to launch

BiomanufacturingDeveloping a new drug that addresses an unmet medical need is a challenging but rewarding objective in the life of a drug-development scientist. But even after a candidate has been identified and regulatory hurdles successfully cleared, there are always a set of new challenges that loom on a new drug’s path to commercial scale manufacturing.

Because time-to-market, risk reduction and production costs heavily influence the overall success of new products, the best time to optimise these key factors of success are the very early planning and development stages of the process, while various options are still under consideration. Managing individual steps from drug development to large scale manufacture requires an approach that efficiently balances know-how between formulation science, pharmaceutical process development and drug delivery technologies, while at the same time meeting the highest standards of quality, safety and stability.

In an era of increasing globalisation and a constantly changing pharmaceutical value chain, top-notch efficiency in developing new drugs – coupled with profound expertise and highly reliable quality of outsourced services – are the biggest hurdles for competitive pharmaceutical companies facing a challenging market environment.

To meet client demand, ProJect Pharmaceutics has developed a unique process for constantly planning, controlling and auditing this highly complex service, thus making it as transparent as possible for areas like risk reduction, time-line definition and cost efficiency.

Advaceutics

Advaceutics – a combination of the terms advantage and pharmaceutics – is the trademarked approach developed by ProJect Pharmaceutics that ensures seamless and integrated process management during all of the required steps that trans- form proteins, peptides and delicate small molecules into a manufacturable drug. Optimised and tailor-made solutions de- veloped under the Advaceutics regime reflect the holistic approach we take from the very beginning, encompassing vital aspects such as safety, stability and cost effective manufacturing, helping to ensure that the process can be transferred smoothly to large-scale GMP manufacturing at a later stage.

Advaceutics is therefore the overall modus operandi for safeguarding client projects. In short, it comprises the following steps:

  • defining the optimal pharmaceutical strategy for a perfect drug presentation through comprehensive consulting
  • applying innovative, science-based technologies to stabilise the native 3D structure of proteins most effectively and reliably throughout the entire shelf life
  • developing innovative depot formulations and drug delivery systems for optimised 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 a pharmaceutical system
  • selecting and qualifying the most suitable CMO for the pharmaceutical system and transferring the technology into large-scale GMP manufacturing

The Advaceutics process ensures that pharmaceutical clients receive the best solution at the best possible time (with reliable, pre-defined time lines) and a strict management of process risks. Although ProJect Pharmaceutics does not develop pioneering drugs on its own, our team believes it is just as rewarding to actively ensure our clients’ future market success by preparing drugs for market.

“From development to launch”, by Dr. Andreas Schütz and Klaus Hellerbrand, ProJect Pharmaceutics GmbH, Martinsried, Germany, in: EuroBioTechNews, Special: Biomanufacturing, No 7-8, Vol 10, 2011, p. 30

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About Project Pharmaceutics

ProJect Pharmaceutics transforms proteins, peptides and delicate small molecules into pioneering drugs. ProJect Pharmaceutics was founded in 2010 and is managed by leading experts in protein formulation and pharmaceutical process development with many years of experience in bio-pharmaceutics.