Making science work

Target groups

If you come to this workshop you will benefit from…
- Presentations from Big Pharma and CDMOs sharing their approach on how
  they select their manufacturing processes for phase III and commercial
  oral solid drug products
- Overview on chosen routes of manufacturing for commercial and
  investigational products from several companies
- The opportunity to contribute to a peer-reviewed publication with
  authorship credit and a contribution to a novel approach of scientifically
  driven decision making

Objective

An international cross-industry and academia working group has proposed
the development of a Manufacturing Classification System (MCS) for oral solid dosage forms based on processing route.

The question of which route of manufacturing to select for the commercial manufacturing of a new solid drug product is an important one for both new chemical entities and new generics and should be based on scientific data and the specific properties of both the compound and the dosage form. In order to help the formulator and process scientist to come up with a scientific rationale for their decision which could be applied throughout the industry a first pre-
liminary concept has been published in 2015 “A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms”
(M. Leane, K. Pitt, G. Reynolds; Pharm Dev Technol, 2015; 20(1); 12-21).

However, this approach needs to be extended and progressed into a suitable working tool which can be applied widely throughout the community based on commonly available data.

Therefore, the MCS working group has teamed up with the APV’s focus group on solid dosage forms to organize this joint expert workshop, inviting all scientist and experts across all areas of the pharmaceutical industry (from
drug substance to drug product, from engineering to clinic), and experts from the regulatory authorities, as well as from academia to participate in this workshop for a more scientific and risk based decision making approach.