Meeting customers’ toughest requirements
We provide expertise and over 40 years’ experience in the Biopharmaceutical Industry, from feasibility studies and engineering to contracting services and turnkey deliveries.
We have provided our solutions to the human blood plasma fractionation industry, meeting the most stringent requirements in the biopharma industries. Our approach integrates technology, process knowledge and quality by design with the automated operations and constructability.
We provide engineering and contracting services from feasibility studies to turnkey deliveries. Our interdisciplinary experience and the vast knowledge of the particular features of Biopharma industries make us the preferred partner for biopharmaceutical projects. NJ’s modern engineering tools and advanced Information and Control technologies enable smooth and successful implementation of global projects with multiple partners and ensure compliance with current Good Manufacturing Practices (cGMP)
Integration of the process technology for the automation of plants and operations provide innovative control solutions for each particular process. Repeatability and traceability are of paramount importance, especially in the pharmaceutical industry, where the processes have to be kept in a validated state. Repeatability is essential when the final product has to fulfill strict product specifications. Traceability is very important when someone wants to scrutinize the process performance and events or if the product has been processed according to the Standard Operating Procedures (SOPs). In Plasma Fractionation the traceability is a regulatory requirement from plasma donors to finished products and vice versa.
Engineering design of a blood plasma facility is very challenging due to special features of this unique raw material. There are many risk factors such as viruses, protein denaturation and contamination in combination with a complex production process. Thus, this is a highly regulated pharmaceutical sector setting high standards for the design and operation of the facility. Therefore product safety, regulatory compliance, traceability and easy operability must be built-in during all design steps. Our approach integrates technology, concepts and process knowledge within the automated operations and constructability.
Neste Jacobs has accumulated vast experience in plasma fractionation since late 70’s and has a substantial library of several fractionation processes. Together with our business collaborators we have alliances that will combine expertise in innovative technologies and services for protein purification and plasma fractionation with Neste Jacobs’s global bio-engineering and construction capabilities.
In most cases a simulation model is built giving the basis of the design and process control philosophy. Process automation made by Neste Jacobs e.g. in chromatographies gives remarkable yields and quality benefits.
For more information, please contact: Kari Kaskes, kari.kaskes(at)nestejacobs.com