Manufacturing and Formulation

Challenges. CDMOS.

Microbiome Therapeutics Manufacturing and Formulation

Biggest Manufacturing Challenges

Harnessing areas of the human microbiome for therapeutics presents unique challenges in drug manufacture and formulation. The fact that there was a fairly even split when naming the biggest challenge between scaling up (34%), GMP quality control (28%) and CMO capability (26%) shows that it is not one single issue holding manufacturers back, but instead a broad range.

Indeed, other answers included ‘drug delivery’, ‘microbiome genetic engineering’, ‘protocol standardization’ and the ‘quantification of strains in a product containing mixed strains of probiotics’.

(All data excludes 86 Not Applicable respondents)

Microbiome Therapeutics Manufacturing and Formulation

Internal vs External Manufacture

When asked about use of contract development and manufacturing organizations, interestingly respondents diverged with their answers based on their location. In Europe, the majority (57%) manufacture externally, whilst in North America that is reversed, with 47% manufacturing internally versus 37% using CDMOs. A common trend is that very few companies – just 15% of all respondents - are doing both.

As the industry develops, formulation and manufacture will only grow in importance, and it will be interesting to track how these challenges are overcome.