October 8, 2021 PAO-09-21-CL-15
The Birmingham site is part of Evonik’s global network of pharmaceutical production facilities, and we work hand in hand with engineering departments at other sites around the world to address specialized needs. This global collaboration ensures that we develop the absolute best solutions for our clients, without compromise.
In particular, we have an ongoing and close working relationship with our Vancouver site, where early-stage clinical materials are produced, with a focus on lipid-based drug delivery systems, such as lipid nanoparticles. In Birmingham, our production equipment and fill-finish lines are tailored to larger-scale, later clinical trials and commercial manufacturing. Because both sites have similar competencies, projects are easily transitioned from Vancouver to Birmingham through the collaborative efforts of the tech transfer teams.
As new projects are brought into Vancouver, we start identifying requirements early on, which prepares the project for transfer to Birmingham. This happens via a close relationship between the teams at both sites, who successfully work to provide constant communication to customers, right from the start. This way, we can transfer the knowledge gained during manufacturing at an early stage to ensure a successful scale-up. If any issues do arise, we have direct access to the process development scientists for proactive troubleshooting. Because of our functionally intertwined systems, the customer benefits from continual support, and we are able to get a very early start on the transition to large-scale manufacturing.
Our development group can take on a project at any stage, from an innovative idea all the way to large-scale manufacturing, and anything in between.
The Birmingham site is equipped with multiple cleanrooms and reactors, in addition to specialized purification and micronization systems, making it possible for us to provide an integrated range of biomaterial and contract manufacturing services. This supports projects from initial feasibility through commercial production of parenteral drug products, which include mRNA vaccines and therapies (with a focus on lipid nanoparticles), and other complex injectables.
Our site’s capabilities do not stop at manufacturing of bulk drug products in our clean rooms and include three core parenteral fill-finish lines. One is designed for small-scale powder production (up to 5,000 vials per batch) of clinical trial materials that can be modified to precisely fill a wide range of powder products. The second is a liquid fill-finish line with lyophilization capability designed for early- to late-stage clinical trials and small-scale commercial production. Our newest and main production line is a Bausch+Ströbel VarioSys® high-speed fill line for liquid and powder product filling that also has lyophilization capabilities. The VarioSys® was designed in such a way that products starting out on the first two fill-finish lines can easily transition to this automated line. Importantly, all fill-finish lines at Birmingham have the capability for aseptic manufacturing.
With Birmingham’s fill-finish lines focused on small to medium-size batches, flexibility and agility are key. The Bausch+Ströbel VarioSys® fill line affords Evonik these attributes, due to its modular design. The inline continuous process makes it possible to get products on and off the line in minimal time, which is critical for sensitive materials, such as lipid nanoparticles. The automated line washes the vials and then sterilizes them in a depyrogenation tunnel, after which they enter the Grade A isolator. Once they exit the isolator, the filled and capped vials pass through another washer to completely cleanse the outsides of the vials and make them safe for operator handling, even for cytotoxic and highly potent materials.
Importantly, the fill line is designed so that the equipment within the isolator can be rapidly and easily switched, allowing for the creation of essentially endless filling line designs within this integrated system. Rather than building and qualifying an entirely new fill line, which can be very expensive and time consuming, the VarioSys® features a plug-and-play design, which allows filling equipment modules to be switched out to fit the fill line to the needs of the process. Only the module, which easily slots into the isolator, is changed, dramatically expanding our production capabilities while reducing cost and time. Overall, this system meets Evonik’s goal of improving the efficiency of development and manufacturing processes.
With the Bausch+Ströbel VarioSys® fill line, we can essentially run any product by customizing the line to fit the product rather than having the product fit the line. Most recently, we began the process of customizing a powder filler for a customer with a powder product that is not compatible with most standard fillers due to the finicky nature of the product. On top of that, we are also customizing a new module for an unusual process, which involves an initial fill, lyophilization, and an additional overlay fill. With our technology, this type of complicated project could take just one year to go from concept to on-site realization.
One of the most exciting trends in biopharmaceuticals today is the surge in interest in mRNA vaccines and therapeutics. Much of this attention can be attributed to the COVID-19 vaccines, but their success has also catalyzed the development of other mRNA candidates. Evonik has centers of excellence in lipid nanoparticles for mRNA products at both Vancouver and Birmingham, along with extensive capability for filling of mRNA products.
Evonik acquired the Birmingham facility in November 2011, gaining a world-class site for the development, scale-up, and commercial manufacturing of bioresorbable polymers and innovative drug delivery systems.
With our wide range of excipients and expertise in parenteral and medical device manufacturing, the Evonik Birmingham site attracts a similarly wide range of clients. Most of the clients that we support with the Bausch+Ströbel VarioSys® fill line are developing personalized medicines. The modularity of the system is an ideal fit for these small-batch drug products, which are often very complex and sensitive parenteral products that require specialized filling solutions, which we are proud to offer.
Caroline Hand is the Lead Production Engineer for the VarioSys® Fill Line at Evonik’s Birmingham Laboratories, specializing in parenteral manufacturing. Caroline led the efforts to qualify and onboard VarioSys® Fill Line to transition the Birmingham site from a focus on clinical phase products to commercial manufacturing. She has been involved with evaluations and product transfers within the Evonik Birmingham site’s tech transfer program as well as customizations to the VarioSys® for client-specific needs. Caroline holds a degree in chemical engineering from The University of Alabama.