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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. 

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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. 

Astrea Pharma will be the new owner of the facility at Fontaine-lès-Dijon

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.

Hydrofluoroalkane (HFAs), or F-gases, have been used as propellants in metered dose inhalers (MDIs) and other inhalation products for many years. However, due to their high global warming potential (GWP) – 1,430 times that of CO2, the United Nations (UN) has committed to reducing global HFA consumption by 80-85% by 2047, with the aim of slowing global warming (1).

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.

Sponsors within the biopharmaceutical industry are increasingly turning to outsourcing for several reasons; remaining competitive and flexible within a quickly evolving sector, gaining access to manufacturing capacity and state-of-the-art equipment and scaling up to the commercial level are just three examples.

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. 

The CDMO inaugurates its new analytical laboratory under Recipharm Analytical Solutions

Medalchemy facility now fully licensed to import, cultivate, extract, manufacture and export medical cannabis flower and extracts