Aseptic Fill Finish Manufacturing


The global biopharmaceutical market is expected to experience rapid growth over the next decade. To prepare for this impending demand, pharmaceutical manufacturers are investing heavily in cutting-edge aseptic fill finish manufacturing technologies to increase production efficiency and efficacy.

Fill Finish Market Growth

Adopting new methods of development ushers in a new set of challenges, however, which is why partnering with an industry leader in fill finish is the key to achieving and guaranteeing success. With the expansion of the Goodwin Biotechnology (Goodwin) facility in Plantation Florida, we have committed $15 million into meeting the market’s needs. This investment includes updating our aseptic fill finish technology. We see this as the necessary investment to meet the market’s demand.

The market growth of biologic products is attributed to a range of factors, including changes in population demographics. As the elderly population continues to grow internationally, there has also been a corresponding increase in obesity and diagnoses of chronic illnesses, such as cancer. Unsurprisingly, the demand from emerging markets, including China and India, has also contributed to the steady and upward growth of biologics. Within the biopharmaceutical market, the monoclonal antibody and complex biologics segments are expected to dominate.

Single-Use Systems, Pre-filled Syringes and Automation

Drug manufacturers must also consider the equipment they use in fill finish production, which should be flexible enough to meet varying drug product manufacturing demands. The adoption of innovative technologies, such as single-use systems made of disposable polymers, aseptic fill syringes and automated or semi-automated filling processes, allows for upgrades to production — though these techniques also introduce new risks.

In single-use systems, more traditional stainless steel filling equipment is swapped out for plastic parts. With this replacement, there is no need to continuously sterilize the equipment. This eliminates the need for energy and time-intensive processes, such as autoclaving or dry heat circulation and for moisture and the sterilization of equipment between batches. Employing a single-use system also frees up crucial space on the factory floor.

Demand is also growing for the replacement of traditional vials with pre-filled syringes. Through the use of pre-filled syringes, waste is minimized and the chance of accidental overflow or contamination of vials is eradicated. With a pre-sterilized syringe, there is no need to repeat sterilization or fill a dose into a vial. Pre-filled syringes are also advantageous because they can be incorporated into production at any scale, from small batches to commercial production. Biologic pre-filled syringes also reach their endpoints faster than traditional syringes and pose minimal risk of contamination. For manufacturers that must demonstrate extreme precision in their packaging stage, pre-filled syringes are an especially desirable option.

A growing trend throughout the supply chain, automation is a means to speed up time to market and increase efficiency. Automation is attractive for a number of reasons, primarily because it minimizes human interaction and thus interference. Automation also reduces the number of personnel needed to complete a process, which contributes to lower costs and helps to maintain consistency of quality. As automation enables continuous processing, more product can be produced in the same time period than with manual production. The downside of automation, however, is that it is a fixed process and therefore lacks the flexibility implicit in human operation, especially if an unforeseeable event occurs.

Investing In Aseptic Fill Finish Manufacturing Capacity

Biologics manufacturers that partner with fill finish experts obtain a significant advantage in the market, given the stringent regulatory demands that are tied to the sterilization process and the nuances of sterilization methods that can impact a formulation at all phases of production. Goodwin’s investment in new Fill Finish technology is in response to this demand. This integrated, multi-year commitment will significantly increase our capacity, benefitting our existing partners and attracting other industry leaders to our site as we lead in the advancement of biotechnology.

One of the highlights of the expansion is the addition of a new flexible fill line. In our partnership with AST, we installed their GENiSYS C® filler. This new fill line will be capable of filling vials, syringes and cartridges and will be available for clients in Q4 2023. With a fill capacity of up to 9600 units per shift, this fill line will significantly increase our overall filling capacity. It has also been designed with high accuracy product dosing to minimize product loss, which is so critical for our biologics clients.

At Goodwin, we are looking forward to continuing our aseptic fill/finish operations and working closely with our clients, in order to fulfill our mission of a Single Source Solution. The planned ongoing expansion at our Plantation, Florida facility will increase our contract development and manufacturing capabilities significantly, not only bolstering our company’s output but also contributing to the industry on a much wider scale.