Formulations for clinical trials and beyond
Budget is often scarce for pharmaceutical development projects before the drug has even shown proof of concept in first clinical trials. In that early stage, many drug developing companies are hesitant to spend the money for a fully-fledged pharmaceutical development of the formulation. Thus, quite often formulations in preclinical studies and clinical stages I and
ProJect Pharmaceutics introduces Predictive Formulation Analytics for a rational design of optimized biopharmaceutical formulations.
Munich/Martinsried, December, 2011 Protein drug formulation is particularly challenging due to structural complexity and instability. The biological activity of most recombinant proteins emanates specifically from their 3-dimensional structure which needs to remain unaltered throughout the shelf-life of the product. However, cleavage or aggregation incidents may not only reduce efficacy but also produce adverse immunologic effects.
EuroBioTechNews: From development to launch
Developing 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.
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. Munich/Martinsried, August 25, 2011 – ProJect Pharmaceutics (www.project-pharmaceutics.com) 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.
Transforming proteins into pioneering drugs – ProJect Pharmaceutics started operations
New pharmaceutical service provider ProJect Pharmaceutics recently opened facility in Munich/Martinsried Munich, December 13, 2010 – ProJect Pharmaceutics started business operations and opened its laboratory facilities in the Biotech-cluster in Martinsried, near Munich. ProJect Pharmaceutics (PJP) transforms proteins, peptides and delicate small molecules into pioneering drugs. Adding value to client’s bio-therapeutic products is PJP’s mission,