In our previous blog post, ‘4 Factors to Consider During the Design Process in Aseptic Manufacturing’, we discussed the objectives that the design process should set out to achieve for new aseptic manufacturing challenges. For our third blog post, we will be discussing the importance of developing flexible solutions that can support next-generation formulations, accommodate different filling environments and fulfil changes in production volumes for years to come. Pharmaceutical manufacturers are becoming increasingly active in the search for evolving technologies that can provide flexible, future-proof aseptic solutions. Although flexible systems may cost more initially and take longer to develop, they have the ability to support the total life-cycle from early-stage manufacturing to commercial production and handle challenging drug properties to eliminate the need to purchase new technologies. As with any automation investment, the goal should also be to ensure improved labour productivity and safety, manufacturing reliability, product quality and, where required, faster throughout to achieve the overall goal of shortening product development lead times. This makes for a cost-effective and robust investment. The increasing complexity of new drugs The increasing complexity of manufacturing new drugs has stimulated a growing demand for flexible solutions. Many traditional filling systems are unable to handle changing drug properties, which impacts the accuracy of doses. As mentioned in our previous blog, it is highly important to specify and design flexible equipment that can accommodate changing properties of the drug quickly (e.g. viscosity of liquids, powder flow properties etc). This agility and flexibility will, for example, be a major enabler for low dose and potent drug handling to support next-generation powders and formulations of the future. This includes the ability to fill very low dose weights of pure API or higher concentrations of...

Demand for the design and development of specialist aseptic manufacturing solutions is being driven by the significant growth in biological drug pipelines, the trend towards personalised medicines, increased out-sourcing of drug development and manufacturing and an ageing population with increasing life-expectancy. In addition, customers are experiencing increasing competition and growing pressures to find cures for cancer, dementia and other diseases which drive significant cost and pressures on our global health services. Consequently, there are growing demands for new manufacturing processes to develop and produce sterile drugs faster and at lower cost. In this 2nd article in our series on Aseptic Manufacturing, we talk about the Design Process, and encourage the reader to consider what wider objectives the design process should set out to achieve for a new aseptic manufacturing challenge, whether for liquid filling, powder filling or device development, the same questions apply.  1.     Design for De-Risking One of the most critical objectives during the design process is to develop and de-risk the core aseptic processes involved in manufacture. From a machine and equipment perspective, it is important to specify and design equipment which will provide agility and flexibility to quickly accommodate changes in the properties of the drug (e.g. viscosity of liquids, powder flow properties etc) and in the design of the primary drug container (PDC) itself (e.g. size, shape, material selection etc). The machine must be capable of supporting the definition of the ‘Critical Quality Attributes’ (CQA) of a medical device or PDC, then based on this must perform aseptic processes that can be measured, with ability to define and record the ‘Critical Process Parameters’ (CPPs) necessary to achieve the CQA’s of the product. An important requirement directly related to the...

What is Aseptic Processing? Aseptic processing is the method of producing a sterile product in which sterile bulk drugs or other sterile materials are filled and enclosed in sterile packaging containers, in a controlled environment where the supply of air, materials, equipment and operators are carefully regulated and controlled to control microbial and particulate contamination within acceptable levels. Aseptic processing is a term which describes the multiple tasks and processes involved in the manufacturing method, which may be completed manually or by semi-automated or fully-automated equipment. One of the most critical processes is the filling of sterile drugs in the Grade A environment, whether in liquid or powder form. The Evolution of Aseptic Processing The aseptic processing market was valued at over $56 trillion in 2018 and is expected to grow to $124 trillion by 2027, with a CAGR growth of 9.18%. The industry has seen many changes over the last century due to a number of challenges including changing regulations, the pressure to develop drugs and devices more quickly and cost-effectively, advances in technologies and the need for customised and adaptable solutions to suit specific manufacturers’ needs in sterile production.  Regulations Sterilisation processes have substantially developed since their methods involved the use of Bunsen burners and boiling water. In the 1920s, sterility requirements for injectables were introduced. These requirements along with mass demand for sterile injectables in WWII began the evolution of fill-finish aseptic processing.   Aseptic processing methods were revolutionised following the lethal contamination of plasma products in 1940. The ‘Blood for Britain’ programme saw mass biological manufacturing of blood and plasma to treat wounded soldiers during WWII. However, the plasma collection process was a haven for bacterial contamination and many vaccines were...