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In this written panel discussion experts in manufacturing in the pharmaceutical supply chain comment on the manufacturing landscape, how sustainable practices are being incorporated more readily, the challenges associated with this and the overall advantages. 

Recipharm receives regulatory approval for the manufacture of a microbiome-based product for the prevention of Clostridioides difficile recurrent infection, under GenIbet Biopharmaceuticals and Seres Therapeutics. 

We are approaching the end of a year which saw global vaccine rollout for COVID-19, 44 novel drug approvals (to date) and the return of the CPHI Worldwide in-person event.

Lyophilisation or freeze drying is an important means to improve thermal stability of a drug product, according to Thomas Becker, Quality Director and Qualified Person, Recipharm. This is particularly true for those that are thermolabile, such as mRNA vaccine candidates.

A summary exploring Recipharm’s key considerations when it comes to developing effective analytical methods for drug projects.

With so many outsourcing options available, selecting the CDMO that is the right fit for any particular sponsor company can be a challenging task.

In January 2020 the European Commission published some proposed significant revisions to Annex 1, the EU’s good manufacturing practice (GMP) guide for the manufacture of sterile products. In the following three-month consultation period, affected organisations and stakeholders from over 70 different countries submitted more than 2,000 comments to the proposed update.