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Accelerated Fill/Finish CGMP Campaign for a Biologic Drug Product Program

Executive Summary 

Manufacturing of biological and small molecule drug products is on the rise, and more often than not, generation of stability data and getting product released for clinical trials are on the critical path to approval. Emergent Camden strives to deliver quality products on accelerated timelines.

A client came to Emergent Camden with an orphan plasma derived product, and needed to start stability the following month. While the material arrived as a pre-formulated bulk, the product was highly sensitive and therefore required a fast thaw. This would require sourcing, procuring, completing an IOQ and PQ on a new water bath, and closing the new product change control to ensure compliance through to manufacturing. Through the collaboration of the Emergent Camden departments, including Technical Services, Production, Validation, Quality Assurance, and Purchasing, the first clinical product lot was manufactured 34 days post the contract being signed. To date, this client has filled 3 clinical products, has 3 additional contracts in process, and has manufactured over 6 additional batches. 

Actual Emergent Project Timeline for accelerated path to CGMP Clinical Trial Material production. 
Figure 1. Actual Emergent Project Timeline for accelerated path to CGMP Clinical Trial Material production. 
NOTE: Timelines can vary based the unique or specific factors involved in a project


The EMERGENT Solution:

A large number of Emergent Camden clients have API manufactured and require some formulation steps to adjust the product concentration prior to filling. Some clients choose to use new container closure systems, and EBSI offers change part qualifications that strive to ensure a successful first product fill. Method transfers are also a service offered by the Emergent Camden facility, including but not limited to UV, SDS Page, HPLC and Residual Moisture. Emergent Camden strives to ensure that client’s method qualification work is completed while the other technical transfer activities are ongoing such that the first engineering run utilizes qualified methods and materials are able to be released prior to the first GMP fill. That way, clients can assure that the engineering run is indicative of the first product fill and the project is set up for success. 

Below is a depiction of timelines that are common at the Emergent Camden facility, although these can vary depending upon a client's specificproduct requirements. Upon signing a contract, we work with you to discuss and set target timelines based on the specifics of your project. A project manager guides you through the entire project and is available at your disposal as the team works to complete project deliverables in accordance with the project plan. 

Depiction of a typical Emergent project timeline for an incoming program with pre-formulated bulk drug substance and utilizing Emergent qualified components. 
Figure 2. Depiction of a typical Emergent project timeline for an incoming program with pre-formulated bulk drug substance and utilizing Emergent qualified components. 


Depiction of a typical Emergent project timeline for an incoming program with novel formulation and method/component qualifications.
Figure 3. Depiction of a typical Emergent project timeline for an incoming program with novel formulation and method/component qualifications.