BIO
Overcoming fill and finish complexities with precision and flexibility
Although ATMPs may provide long-term benefits with a single dose, their high production cost may limit their utility.
Precision is critical in minimising precious material loss in ATMP filling, helping to control manufacturing costs and ensure innovative therapies reach patients.
ReciBioPharm has a wealth of experience providing contract filling and supporting the filling needs of customers around the world.
Supporting your unique therapy
We have the capacity and ingenuity to address challenges in fill and finish for ATMPs, including the modalities below:
We know that when you’re searching for a fill and finish partner for your advanced therapy, details matter. That is why we have multiple configurations available to find the best fit for your product.
Our extensive biologics services span several modalities to provide you with various options when developing a manufacturing approach for your ATMP.
Our fill and finish capabilities:
- DIN 2-10R Glass and Crystal Zenith® Vials
- A range of vial and syringe formats available for integration
- <10 mL line loss in filling assembly, depending on the configuration
- Single-use product flow paths, depending on the configuration
- 100% IPC weight check, depending on the configuration
- 0.5% or better filling accuracy (depending on fill size)
- Automated fill-in isolator, ISO 5/Class 100 (Grade A)
- Automated batch sizes of up to 30,000 vials
- Semi-automated small batch sizes as small as 100 vials
- Manual fill-in BSC with autopipette to 1,500 vials
- Integrated SKAN particle counter
- Integrated H2O2 decon
Reduce the risk and choose ReciBioPharm for your entire ATMP manufacturing journey, from start to finish.
Quality, above and beyond
We understand how precious your material is and take pride in ensuring minimal product loss in ATMP filling. Trust our team of experts to rise to the challenge and give your biologics product the best fill and finish possible.
We adapt with you. Our flexible and agile approach to problem-solving is pivotal to our fill and finish success with innovative advanced therapeutics. We can support you in filling a wide range of biologic formulations, including liquid solutions and lyophilized powders. We can also deliver small batch volumes with a low dead volume.
We are meticulous in our approach and relentless in our pursuit of quality.
We are with you every step of the way, with dedicated expertise and support, from drug substance manufacturing to drug product fill and finish. We provide support for all of your drug substance and product needs in one place — one partner, with an impressive global reach.