The Problems with Fill Finish Services Not Finished

 

The Problems with Fill Finish Services Not Finished

Before we dive into the challenges with fill-finish services not finished, let us do some defining. We shall define what Fill Finish Processing is. We shall also explain what Aseptic Fill Finish is.

At Abbvie, we offer GMP-certified manufacturing capabilities. We process over a million vials annually with an automated filling line. Your drug product’s fill and finish procedures can be suited with customized packaging and labeling. 

Aseptic Fill Finish

Aseptic fill and finish is an aseptic process that needs complex interaction and close coordination between sterilized filling components, sterilized products, support and cleanroom facilities, personnel products, and the manual fill and finish equipment system.

Fill Finish Processing

After the upstream bioprocessing, fermentation, or cell culture formation of active agent and downstream purification is when the final product has the most significant value.

At this point, any mistake can lead to improper packaging or contamination of the products.

The Challenges

1. Providers lack the full range of analytical testing capabilities that they claim to have. And due to this, they are unable to release products. It is great to have the capabilities to do ninety percent of tests. However, it forces one to qualify for an alternate place to have the remaining few tests performed.

2.  There are needs for matching the volume of production in the development/clinical phase with the commercial phase. Before now, one required a flexible schedule but a small volume. And one needs the CMO for commercials to adhere to the forecast. However, they have accepted some upside if required.  

3. There is not enough capacity with the providers at the capability.

4. In terms of the completion of Process, performance and qualification run, and technology transfer, CMO has continued to make overpromising and under-deliver. The ability to balance available capacity and timing with project management resources has continued to be an issue that contributes to the problem with meeting timelines.

5. There is a formulation of cells in cryopreservation, limiting fill time before there are losses in cell viability. 

6. Prefilled devices should be replaced with processes that are automated. This is to ensure the reduction in opportunity for error and time, as well as the removal of the manual process.  

7. In drug fill-finish, there is presently an absence of long-term storage space for vials that are unlabeled at CMO facilities.

8. Because labeling occurs before cryopreservation, it makes visual inspection to be complicated.

9. The coordination between manufacturing and analytical is less optimal. While manufacturing is pressed on as fast as possible, the analytical teams are unable to execute the transfer on time to reach the manufacturing deadline.

10. Because drug product fill takes place at the same facility as drug substance production, all the operators at the CDMO must be trained specially for both drug product fill and drug substance production.

At AbbVie, the nature of your biologic drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable, safe, and ready to use products. To learn more about how we can assist you with aseptic fill-finish, feel free to contact us and reach out to us; we shall be more than pleased to support you.