4 Tips to Optimize Fill-Finish in Pharmaceutical Manufacturing

Pharmaceutical manufacturers working to bring high-quality, safe, and effective drugs faster to patients must optimize every stage of drug discovery, development, and delivery for speed and efficiency. This need is especially evident during the final and most critical phase: the fill-finish manufacturing stage.

Read on to learn about four strategies for more efficient fill-finish performance.

Why Fill-Finish Matters

Fill-finish consists of the processes and activities following the preparation of the drug substance into a final formulation for administration. For injectables, this includes filling, sealing, and secondary packaging. This stage, which turns the formulated drug substance into a product that can be distributed and administered to the patient, is one of the most complex and costly phases of pharmaceutical manufacturing.

Every action taken at this point can make or break the entire manufacturing effort, impacting the final drug product's quality, quantity, and efficacy. In severe cases, errors could render the batch unusable, slowing production and depleting resources, and ultimately, delaying important therapies from reaching patients.

Here are four key strategies for improved fill-finish techniques.

Conventional fill-finish machinery consists of fixed reusable equipment. This type of equipment often requires costly and time-consuming operational steps to get up and running and high capital investment and lead time. Assembling, cleaning, sterilizing, disassembling, and storing the equipment may require operator intervention, potentially compromising the environment and drug product sterility. These steps may also risk exposing operators to hazardous drug waste.

Single-use technologies, on the other hand, offer a flexible and convenient workflow for the fill-finish stages of drug products. Because these items are designed for one-time use and disposal, they require minimal setups and human handling.

These features reduce the risks of contamination and equipment failure, enabling shorter and faster production timelines.

Contamination leads to slowdowns, halts, or even restarts at the final stages of manufacturing and, even worse, drug product recalls after launch. A recent article in Drug Discovery Today evaluated FDA medication recalls from 2012 to 2023 and found that contamination and sterility-related issues significantly contributed to drug recalls. These issues, such as cross-contamination, foreign particles in drug products, and improper sealing, are at risk of occurring during the fill-finish manufacturing process.

Improving systems that prevent, detect, and address potential contaminants throughout the fill-finish line can also help improve the speed and efficiency of operations in this stage. A risk-based approach should be used to identify the highest risk to the process and identify mitigations to appropriately address these risks.

Limiting human interactions during this phase is also important. You can achieve this by switching to automation, robotics, and single-use technologies, which you can read more about later in this article.

You can also invest in high-quality bioproduction consumables and primary packaging containers for uninterrupted filling, such as those offered by Corning.

Primary packaging component performance can be another obstacle to fast, efficient filling lines and drug product safety. For example, conventional uncoated glass vials typically have a high coefficient of friction (COF) on the exterior surface, which can lead to operator interventions, vial jams, tip-overs, and glass breakage. These disruptions can lead to longer manufacturing times, increased manufacturing costs, and greater human intervention in the fill-finish process, increasing contamination risks.

While several requirements must be considered for primary packaging selection and use, there is a simultaneous urgency to develop advanced therapies on time. In response, manufacturers need alternative glass vial solutions that enable drug production efficiency and protect the final drug products.

One practical option for improving the fill-finish process is using vials with a low COF external coating. Glass vials equipped with Corning's proprietary low friction external coating can reduce the possibility of damage. This protection also reduces cosmetic defects, product loss from particle contamination and compromised container integrity, as well as the risk of costly product recalls.