Planning preclinical-clinical developments for your technology? Looking for a robust and scalable manufacturing process? Need to develop & validate specific analytical methods?
PTS provides complete support to transition from R&D, prototype optimisation, GLP TOX studies, clinical trials and market authorization through a comprehensive and step-wise process development and scale-up approach. 8 Clean Rooms (4 GMP suits) fully equiped to manufacture any type of polyamino acid-based therapeutics.
Our company can also perform formulation screening for your drug product and provide GMP Fill & Finish of aseptic vials and other non aseptic formats in small batches (15.000 vials) to support your (pre)clinical development.
Excellent feedback from regulatory agencies on the CMC packages delivered to date from both EMA and FDA. Consistent reproducibility across the different project stages and scales. GMP certificate from Spanish Authority based on part 2 2001/83/EC Directive.
PTS has been a very valuable and reliable CMO partner for the past 3 years. The team is very supportive, solution-oriented and dedicated, always willing to go the extra mile to provide excellent results on time. We have been appreciating the tangible long-term vision and value-creating mindset that this company has.
PTS has proven itself to be a capable and reliable partner. Over the past two years, we have been repeatedly impressed by their knowledge and professionalism. The PTS team has been both skilled and responsive to our needs, as well as innovative in meeting new challenges. Simply stated, PTS has brought real value to our programs and to our company. We look forward to the next phases of our relationship.
I have been fortunate to work with PTS on a number of projects where they have been an excellent partner as a CMO and fantastic team members in research and development activities. Having worked in the polypeptide field for more than 25 years, I have seen and been involved with many efforts to commercialize these specialty polymers. In my view, PTS has achieved a depth of understanding and a level of expertise in polypeptide manufacturing and analytics that is second to none. I see PTS as a tremendous asset to the polypeptide community, and highly recommend them as a valuable resource for all polypeptide manufacturing needs
Working with PTS on the development of novel polymers for our nanosystems was really profitable. Their expertise in the field of polymer synthesis and characterization enabled us to conduct state-of-the-art research. It is worth mentioning that PTS personnel efficiently supported us with their knowledge at all stage of our collaboration, while timely and successfully completed their tasks. Taking into account everything above, we would be happy to collaborate again with them.
We have found with PTS a partner, who has profound and deep know-how in both technical aspects of developing and manufacturing real innovative carriers in the field of polymer therapeutics and furthermore a deep understanding for the administrative and documentation necessities in the pharma world. Both is extremely important and valuable, as new developments in the field of biopharmaceuticals require a solid technical understanding from chemistry to pharmacology to biochemistry and medicinal chemistry, as well as the special regulatory aspects, which have to be matched by any party acting in the health industry.
Filling the gap between academia and industry is a big challenge. PTS is an ideal partner for application-oriented academic research in order to transfer fundamental research into the market. PTS research team possess a high level of training in scientific research combined with a privileged vison of the societal needs.