What's happening?

As we have discussed in previous insights, there are several challenges hindering the widespread adoption of self-administration for highly viscous formulations, for example some biopharma treatments.

Thought and foresight into method development stages can ensure costly errors and delays are avoided later. Method development is a critical and continuous process that, if optimised, ensures successful progression of a drug product through its life cycle to commercialisation.

There is a need to adopt more environmentally friendly pMDI propellants, not only to reduce carbon footprint, but also to mitigate supply issues that may result from the decline in the use of existing propellants.

The growing burden of chronic diseases and elevated global awareness of vaccines is leading to a surge in outsourcing formulation development services.

Inhalation products are some of the most complicated and challenging drug dosage forms and are extremely complex to develop and manufacture. It is important to understand potential interactions between the formulation and the delivery device throughout the development stages, as well as when it reaches the end user. 

The rise of such combination products means that the integration of pharmaceutical and device regulatory requirements at the development stage is more important than ever before. 

The most significant change for devices such as autoinjectors is that now the device is no longer considered as just secondary packaging under medicinal regulations.

Modified-release dosage forms present new opportunities for drug developers and can help overcome challenges, such as short biological half-life or poor bioavailability due to degradation in the stomach.

The European Commission published its proposed revisions to Annex 1, Manufacture of Sterile Products, the EU’s good manufacturing practice (GMP) guide for sterile products, in February 2020. Following a second consultation period, which ended in July, the guidance has now been comprehensively updated to reflect the industry’s changing needs and challenges. 

Drug delivery systems offering modified release have grown significantly in popularity in the pharmaceutical sector in recent years. 

In your opinion, what will be the biggest challenge(s) facing bio/pharma companies in Europe in 2021? (Feel free to list numerous entries here and elaborate where possible)