Assignment task: Currently, the manufacturer is facing the following product-related situations:
1. Due to the adjustment of dosage for this new indication, it would require supporting 3200 patients' clinical data with new treatment regimen for 6-months and the clinical team has proposed that the product should be supplied as an investigational product2 to the registered clinical sites prior to 6-months from September 1, 2023. The expected quantity to be supplied is 48000 I.V. vials.
2. Additionally, due to a raw material supply (and supplier) issue, the manufacturer is already planning and seeking replacement with a new Tier-1 raw material supplier. Technically, such raw material changes could impact the in-process material, active formulation constitution, that may not conform to the predetermined specification to one or more processing steps that are different from the established manufacturing process in order to obtain acceptable quality in-process material. Further, the manufacturer has learned that a batch supplied by this new Tier-1 raw material supplier to another manufacturer for their marketed product is under
1 The case scenario product is named hypothetically as "Product ABC", for the purpose of this project assignment, however, the first hypothetical product described with its indication represents an actual marketed product.
2 The investigational product is hypothetical, and not a marketed product.investigation due potential ingredient which could be contaminated and could potentially cause public health concerns.
3. Currently, the manufacturer is also planning to scale-up the commercial production of this current marketed product (i.e. original dosage), and establish a validated cGMP plan in partnership with a contract manufacturer outside the US, and this transfer would allow to start production in the next 6-months.
Based upon the assessment of the raw materials team, the current materials stock would only allow production of 40,000 I.V. vials. Therefore, the manufacturing team is facing a dilemma of whether to focus on the reformulation and supply of investigational drug batches to the clinical sites or to use the raw materials to meet the market supply and demand.