SP Process Development

Your Idea from Laboratory to Commercial Application

About SP Process Development
SP Process Development (SPPD) is a national research institute focusing on chemical processes and pharmaceutical development. The institute is located at Biovation Park in Södertälje and has since the inauguration in February 2013 established a number of collaborations with both national and international companies and research organizations.  SP Process Development is part of the SP Group, the SP Technical Research Institute of Sweden.  The majority of the current personnel have a background from industrial pharmaceutical R&D with profound experience of drug substance and drug product development throughout the preclinical and clinical program to launch.

SPProcess1What we do
•     We run CMC-projects from preclinical research to the clinical trials stage.
•     We lead research projects in collaboration with SMEs and academic research groups to drive ideas and innovations from the laboratory to commercial application.
•     We solve challenges and complex problems that are commercially or industrially significant within chemical, technical, analytical and medical applications.

Our key areas
We offer expertise in the following areas:

Synthesis and Chemical Engineering– Our track record in delivering sustainable chemical process solutions in agreement with regulatory is robust.  On all processes where chemical transformations are utilized, chemical and engineering competences are applicable. This saves time and reduces cost during the complete process design.

Catalysis- SPPD has a complete platform and techniques in place for high throughput development of catalytic processes e.g. a  ChemSpeed™ HTS reaction screening robot, a Parr™  high temperature and pressure batch reactor system (up to 500°C and 350 bar) and  a large glove box for inert atmosphere handling and storage.

Continuous Processing- SPPD has thorough competence in continuous processes and process intensification.  Test equipment for feasibility studies or proof of principle is available in our technical laboratory. We can help our customers to develop new ideas, to scale up the process or to give support to implementation of new processes.

Preformulation, Formulation and Drug Design- SPPD offer support to early development of new pharmaceuticals. Our experimental and predictive tools increase the probability of success of new drug candidates and allow us to identify the best administration route and formulation.  A new GMP production plant is in place for production of chemicals, pharmaceuticals and clinical trial material up to 5.0 L/5 kg supply (100 L scale equipment).

Crystallization and Solid State-The experience at SPPD within the solid state area as well as material design is deep. We perform all types of crystallization work; polymorph and salt screenings as well as advanced solid state characterization e.g. single crystal X-ray diffraction.  The unique combination of long experimental experience and a strong platform of in-silico predictions and calculations increase the probability to solve difficult solid state problems and the success of e.g. screening work.

Analytical Development- Analytical development can give solutions to complex chemistry problems. We use a broad range of different techniques like chromatography, spectroscopy and spectrometry, as well as molecular structure characterization. Identification of small impurities in products can be done by using UPLC-MS/MS analysis or 1D and 2D NMR analysis for characterization.  We perform GMP analysis to support the production unit as well as a service to external customers.

Collaborations with industry and academia
Our business is both fee-for-service commercial R&D for industrial partners and grant-financed research together with industrial and academic partners. We have thorough experience from EU-projects and other collaborations between industry, academia and institutes.

For more information contact:
CEO Magnus Larsson, Mobile: +46 70 344 65 14,
Magnus.Larsson@sp.se

SPProcess2

Forskargatan 20J, SE-151 36 Södertälje
+46 (0)10 516 65 00
+46 (0)70 344 65 14

http://www.sp-pd.com