Additional services
Beyond our aseptic fill & finish services, we offer a range of additional services to support seamless progression from development through to clinical and commercial supply. These services are delivered in close cooperation with our European partners for tailor made solutions.
The additional services offered through BioConnection are coordinated by our team, ensuring full alignment with our fill & finish operation, quality standards, and project timelines.
Development services
We offer development services to support the preparation of injectable drug products for aseptic fill & finish. These services are intended to ensure that formulations and processes are robust, scalable, and suitable for transfer into GMP manufacturing.
Development activities include formulation development for liquid and lyophilized injectables, as well as process development to define critical parameters for aseptic filling. Lyophilization cycle development is supported to optimize product quality, stability, and manufacturing efficiency.
Analytical development is also available to establish methods required for in-process control, release testing, and stability studies, supporting a smooth transition from development into clinical and commercial manufacturing.
Analytical services
A broad range of analytical and microbiological testing services is available to support injectable drug products throughout development and commercial supply. These services are aligned with applicable regulatory and pharmacopeial requirements.
Analytical services include stability studies, container closure integrity testing (CCIT), and method validation or transfer as required. Microbiological testing services include sterility testing, bioburden determination, and bacterial endotoxin testing.
Secondary packaging
Secondary packaging services are available to support the supply of market-ready injectable drug products. These services are coordinated to align with fill & finish operations and overall supply chain requirements.
Packaging services include labeling and packaging of vials and prefilled syringes for both clinical and commercial use. Packaging configurations can be adapted to meet country-specific and market-specific needs. Serialization services are available when required.
Let's connect
If you’re exploring fill & finish support for an upcoming or ongoing program, we’d love to learn more about your goals and how we can contribute to your success. Whether you’re evaluating partners for a new project or preparing for your next development milestone, our team is ready to support you with clarity, expertise, and flexibility.
Share a few details about your molecule, timelines, or specific challenges, and we’ll follow up with insights tailored to your needs. By understanding your priorities early, we can determine how our capabilities, capacity, and approach align with your plans. We’re here to help.