4.1 Supply Chain in the Biotech/Pharma Industry

The pharmaceutical supply chain can be described as the network that encompasses production, distribution, and delivery of pharmaceutical products from manufacturers to end-users. It plays a pivotal role in ensuring the availability, quality, and safety of medications. End-to-end Supply Chain of Pharmaceutical products include:

• Sourcing (Raw materials, packaging components etc.)

• Production (Drug substance, drug product, finished product)

• Delivery (Distribution centers, end customer, e.g. patients, hospitals, pharmacies)

Personalized medicines and many ATMPs such as Car-T cell therapies require very unique supply chain concepts (make-to-order, no economy of scale, starting material sourced from patient, direct delivery to hospitals). These very specialized concepts require other concepts as described here.

Supply chain concepts during conventional drug development (small molecules, biologics, ADCs) include the following parts:

1. Drug supply for non-clinical studies

2. Clinical supply (for clinical studies)

3. Commercial supply

This lecture will mainly consider 1. and 2. above, whereas 3. detailed planning of commercial supply starts at a much later stage. However, commercial supply has to be considered from the development perspective at an early stage – can the product be manufactured at a commercial scale, and what is necessary to bring it there?