Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology either as part of completely single-use processes or as hybrid solutions.
Discussions are widespread about the paradigm shift in the manufacturing site design and flexibility needs of the biopharmaceutical industry.
Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.
To make biofuels such as bioethanol and biodiesel competitive with fossil fuels extensive research in the field of process development is needed. Taking into account the special requirements of biofuel production, such as high temperatures, multi-step procedures and anaerobic conditions, effective tools for streamlining development efforts must be provided.
According to both USA cGMP and EU GMP cleanroom classification should be carried out according to ISO 14644-1. The 19994 version of this ISO standard has been re-written by a group of international subject matter experts and ISO 14644-1:2015 was published on December 15, 2015. ISO 14644-1:2015 contains substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.
Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.
The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules and reduced average production volumes.
Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered. Read this white paper to learn about the regulatory and clinical development strategies that help define pharmaceutical and biologic combination products, the need for early establishment of regulatory and clinical strategies, and how to best understand user needs and determine product requirements.
Human-centred designs have become a driving trend in the development of next-generation inhalation devices, making them more useful, usable, and desirable than current inhalation devices. By applying design research, industrial research, and human factor disciplines in cooperation with design for manufacturing and assembly philosophy, patients are able to receive inhalation devices that minimize opportunities for error, and support greater adherence to their prescribed therapy.
This white paper describes Phillips-Medisize’s approach to human-centred design in producing the next generation of smaller and smarter inhalation devices.
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
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