NextPharma, a European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it has received an award from PharmInd for a Process Analytical Technology (PAT) research project to assure the quality of a pharmaceutical product by online measurement of critical process parameters.
PAT tools are a regulatory requirement covered under the International Conference on Harmonisation (ICH Q8) and a requirement of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NextPharma’s focus as part of the research project was the online measurement of moisture determination in the granulation processes for solid dosage forms. Measurements of moisture content are required to optimise the time for the granulation process; non-optimisation can lead to variations in product quality.
The work involved collaboration between NextPharma, the University of Düsseldorf (Institute for Pharmaceutical Technology), the granulation equipment manufacturer Glatt and the sensor provider Advanced Microwaves Systems.
As part of this work a microwave sensor was installed in a fluid bed granulator to measure granule humidity through simultaneously measuring water and density without being in contact with the product itself. As a result of this work online measurement of product humidity can be monitored over the whole granulation process and enables the accurate determination of the granulation process end-point as well as any deviation during the manufacturing process, improving manufacturing yields and reducing variability.
The project was published in the journal “Pharmind” (www.pharmind.de) and was also granted the second prize for the year’s best article.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services (PDS) commented: “We are very excited to have been part of this collaborative piece of research work and delighted to work alongside the University of Düsseldorf, Glatt and Advanced Microwaves Systems in producing a very positive outcome through enhancement to granulation manufacturing quality, as well as being recognised by PharmInd for this award”.
Bill Wedlake, Chief Executive Officer of NextPharma added “At NextPharma we believe that scientific innovation is central to cost effective manufacturing of pharmaceutical products. Given the growth of outsourcing within the pharmaceutical and biotechnology sectors we are aware of the importance that organisations like NextPharma play in providing scientific innovation and of the increasing reliance on external partners like NextPharma to help to deliver this very important work”.
NextPharma PDS operates globally with seven centers of excellence in Europe and North America. PDS services include preformulation studies, formulation development, design, development and optimization of lyophilisation cycles, manufacturing for clinical trial materials, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines as well as regulatory support and product dossier development and registration.
Our expanded sterile business includes sterile product development and manufacturing capabilities in San Diego, California and Braine-l’Alleud, Belgium where we are able to support non-clinical through clinical development of sterile products including biologics and cytotoxics. In addition, our San Diego facility is ISO 13485:2003 certified for medical devices and manufactures medical devices with batch sizes spanning the needs of research and development through to commercial quantities of product.
Our world class PDS team provides customers with the confidence and knowledge that their products will be produced to meet their exact requirements. Customer satisfaction is of key importance to NextPharma: each customer receives a dedicated project manager responsible for managing the development project within NextPharma and ensuring the highest level of customer service. As products transition from development to commercial scale, we are able to provide a seamless process from non clinical product formulation to commercial scale manufacturing, either within NextPharma, or if the customer requires to another company of their choice.
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.