The rise of complex biologics, glucagon-like peptide-1 (GLP-1) receptor agonists and advanced therapies is placing unprecedented demand on fill-finish operations. These products require specialized handling and advanced delivery formats, often in varied batch sizes. At the same time, manufacturers must adapt to stringent regulatory standards for aseptic processing, such as the European Union Good Manufacturing Practice (EU GMP) Annex 1.
To understand how leading manufacturers are addressing these challenges, Manufacturing Chemist sat down with Tommy Schornak, Senior Vice President of Injectables at Kindeva Drug Delivery. We discuss the thinking behind Kindeva's world-class Bridgeton facility, its ability to balance flexible and high-volume production with quality, and the integrated strategies required to succeed in this complex environment.
1. What made Bridgeton the right place for Kindeva to invest in, and how does the new facility help to tackle some of the big challenges in sterile injectable manufacturing today?
The pharmaceutical sector is witnessing a surge in demand for sophisticated biologics and other sterile injectables, including the rapid growth of GLP-1s. This creates an urgent need for scalable manufacturing solutions. We invested in Bridgeton because it was purpose-built to provide this scalability.
A common challenge in our industry is the siloed approach, where companies use multiple partners for development, drug substance manufacturing and fill-finish. This disconnected process introduces unnecessary risks, from tech transfer inconsistencies and potential regulatory issues to delayed timelines.
Our Bridgeton facility was designed specifically to solve these challenges. It offers fully integrated capabilities across fill-finish, product assembly and final product packaging, all within one geographic location. This streamlined approach allows us to handle a diverse range of projects, from clinical trial batches to large-scale commercial manufacturing, ultimately reducing risk and accelerating time to market for our partners.
2. Can you walk me through the thinking behind the facility’s design and how it’s set up to meet EU GMP Annex 1 standards?
Our core design philosophy for Bridgeton was centered on patient safety and unwavering compliance. We knew that regulatory standards for aseptic processing, particularly the 2022 revision of EU GMP Annex 1, place a strong emphasis on engineering controls and technical solutions, such as isolators and Restricted Access Barrier Systems (RABS), that physically separate operators from sterile products.
With Bridgeton, we embraced a compliance-by-design approach from the very beginning. The facility is engineered to be fully Annex 1 compliant, with a key feature being our investment in advanced isolator systems, which provide a closed, controlled environment for all of our high-speed filling lines across vials, syringes and cartridges.
These state-of-the-art aseptic processing lines are engineered for maximum sterility and ensure complete compliance with both Code of Federal Regulations (CFR) and Annex 1 regulations. This design supports a robust contamination control strategy and provides the highest levels of product integrity.
3. With capacity for more than 100 million units a year, how do you strike the balance between high-volume output and maintaining the highest levels of quality control?
We strike a balance between this high-volume output and quality by designing quality into the process from the start. This is achieved through extensive automation and integrated data monitoring.
Our high-speed filling lines, for example, are equipped with advanced, real-time quality controls. For our syringe filling lines, this includes 100% in-process control (IPC) for fill weight and plunger height, combined with automated pre-use post-sterilization integrity testing (PUPSIT) for the sterilizing filters.
Our vial filling line utilizes on-line crimping inspection, which is essential for verifying container closure integrity and protecting the product from contamination.
Our cartridge line also performs 100% IPC for volumetric fill checks, guaranteeing that every unit delivers the exact specified dose for patient safety.
All these lines capture critical process data in real time via statistical process control (SPC). This digital oversight provides end-to-end visibility and ensures that every dose meets specification.
4. Kindeva takes an integrated approach at the site: how does that make the whole process, from development through to final assembly, more seamless?
Our integrated approach is a direct response to the complexity and risk associated with disconnected supply chains. At Bridgeton, we offer fully integrated capabilities, including fill-finish, product assembly and final product packaging, all within one geographic location.
This is more important than ever because regulators increasingly view the contract development and manufacturing organization (CDMO) and the license holder as one entity, holding both accountable for product knowledge and compliance.
When these steps are handled by separate vendors, programs face significant risks. These can include a higher potential for contamination, inconsistencies during tech transfer and production slowdowns from coordinating different teams.
By consolidating these services, our Bridgeton site eliminates those risks. This model streamlines the entire process, minimizing complexity and enhancing control. By providing a single, unified platform, we simplify tech transfer and ultimately accelerate our partners' products on their journey to market.
5. As sustainability is such a big focus in manufacturing today, what steps have you taken at Bridgeton to cut down on environmental impact?
Sustainability has become a collective focus of the industry, and when planning a new greenfield build like Bridgeton, these considerations can be integrated from the ground up.
For example, the facility is equipped with a state-of-the-art Building Automation System (BAS) that actively manages and monitors all critical utilities. This allows us to optimize energy consumption across our HVAC, lighting and process equipment. We also designed our Water for Injection (WFI) generation and distribution loops to significantly reduce water usage without compromising quality.
This is crucial because sustainability is as much an internal goal of ours as it is a key part of our partners' supply chains. Therefore, a modern facility's energy efficiency and water usage are becoming key factors in partner selection, as clients will actively choose new, well-designed facilities with a low environmental impact. Designing with this foresight is essential to meeting the long-term expectations of our partners and the industry.