Commercial manufacturing of current good manufacturing practice peptides spanning the gamut from neoantigen to commercial large-scale products

Good manufacturing practice for immunological veterinary medicinal products.

Good manufacturing practice (GMP) is applied to the manufacture of immunological veterinary medicinal products (IVMPs) in a number of regions around the world. Within the European Union (EU) there are well-established requirements for GMP in the manufacture of IVMPs. Maintaining GMP when producing IVMPs is important because there are particular risks associated with their manufacture. These ris...

Current good manufacturing practice for positron emission tomography drugs.

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulatio...

Evaluation of the Financial and Technical Impacts of Changing Commercial-scale Pharmaceutical Manufacturing Processes

Growing pressures in the pharmaceutical industry are driving the need to optimise processes used for the manufacture of drugs at commercial-scale, in order to improve cost of goods, product throughput and production times. Evaluating the impacts of process optimisation upon these metrics presents a challenge due to complexities and trade-offs that are often encountered when developing a typical...

Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

From Theory to Practice: a Total Ergonomics Model of a Manufacturing System

The objective of this paper is three fold. First, a general framework for development of total ergonomics model is introduced. Second, it is described how total ergonomics model may be applied in practice to intensify the productivity and working conditions of manufacturing systems. Third, it is shown whether the total ergonomics model is superior to the conventional ergonomics approach. This s...