Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses. This manufacturing proc...

Continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end product quality as desired by QbD (quality by design)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires corrective actions in the process/raw material variability before product quality can ...

The aim of this paper is to develop an optimization model for quality improvement by considering quality investment in rework policies and supply chain profit sharing. To improve product’s quality, the decision of process target and its tolerance is important since it directly affects the defective rate, manufacturing cost, and loss to customer due to the deviation of product from its specifica...

Metal forming processes, compared with machining ones, reduce production steps and increase manufacturing speed in addition to saving raw material. In this paper, forming process of column of a steering mechanism is investigated by finite element analyses and experimental tests; and optimum die design parameters are found. Forming process parameters including die opening angle, bearing length, ...

This white paper reviews how the Process Analytical Technologies (PAT) originally developed by the FDA for the pharmaceutical industry can also improve quality and efficiency in medical device manufacturing. The underlying principle of the PAT approach is that quality should be designed into the product based on a fundamental understanding of the critical manufacturing processes. This understan...

Most radiation therapy machines are based on microwave linear accelerators. Manufacturing reliable accelerators and hence, reliable radiation therapy machines requires accurate, efficient, and well-controlled processes throughout the steps of electron accelerator manufacturing. Statistical Process Control (SPC) techniques are utilized at Siemens – Oncology Care Systems (OCS) to meet these requi...

10.4103/japtr.JAPTR_343_17 Dear Friends, Based on quality risk management, the pharmaceutical quality by design (QbD) has been emerged as a logical methodology for the development which commences with prior delineated goals and accentuates better understanding of product and process control. The basis of QbD strategy is International Conference on Harmonization guidelines. QbD approach is surfa...

The Model Predictive Control (MPC) method has been widely accepted as a useful tool for keeping the quality on target in the manufacturing process. However, the conventional MPC methods are inadequate for the large-scale manufacturing process particularly in the presence of disturbances. The goal of the paper is to suggest a Partial Least Square (PLS)based MPC methodology for accommodating the ...