With over 10,000 Sq.m of fill finish footprint, we can support filling of a wide range of presentations - vials (liquid and lyophilized), pre-filled syringes and autoinjectors.
Our automated facility for fill finish services efficiently handles high-accuracy, high-viscosity, low-volume protein filing. End-to-end single-use capability enables for faster change over and assurance of cleaning validation.
Our integrated approach to quality management systems enables greater flexibility and leverage pan - organization experience in managing regulatory audits.
Fill Range and Presentation
Fill range is 0.1-100 ml, Vials: 2-100 ml, PFS and auto injector: 0.1-1 ml
Manufacturing Process Flexibility and Formulation
- Manufacturing process flexibility: peristaltic, rotary piston, end-of-end single-use system, sterile filling
- Formulation: liquid, lyophilized
Why Aurigene Fill Finish Development and Manufacturing Services?
100+ successful regulatory audits
10+K Sq.m facility footprints
300+ tech operations professionals
Operations supported by digital infrastructure
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Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Learning Resources
MAY 19, 2023
“Bathtub Chemistry” - Necessity and Aspects of Process Research
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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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Development of novel paullone-based PROTACs as anticancer agents
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March 13, 2025
Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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Frequently asked questions
What are the syringe fill-finish manufacturing requirements?
Syringe fill finish CDMO development requires strict control of product sterility, particulate levels, and container-closure integrity. Key syringe fill-finish manufacturing requirements include an appropriate cleanroom environment, validated aseptic filling processes, qualified equipment, and trained operators. Material readiness is also critical: syringe type (glass or polymer), siliconization, plunger and stopper compatibility, and needle/shield configuration must match the drug product. As part of fill finish manufacturing services, Aurigene also emphasizes validated sterilization or sterile filtration strategy, in-process controls, and end-to-end traceable batch documentation to meet regulatory expectations.
What are the fill-finish processes to ensure product quality and manufacturability?
Fill finish development services focus on building a robust process that consistently delivers a sterile, stable, and manufacturable drug product. Typical fill-finish processes include formulation readiness checks, sterile filtration (as applicable), aseptic filling, stoppering or plunger placement, sealing/crimping (for vials), visual inspection, and container-closure integrity testing. For syringes, process controls around filling accuracy, air bubble control, and component handling are important. A strong fill finish services CDMO approach also includes process validation, environmental monitoring, and stability-supporting packaging decisions to ensure product quality across shelf life.
What needs to be considered while doing large-scale fill finish manufacturing?
Large-scale fill finish manufacturing services require careful planning to prevent variability and ensure consistent output across long runs. Key considerations include line speed and throughput, equipment capability, aseptic interventions, hold times, and a consistent supply of qualified primary packaging components. Scale-up also needs strong contamination control, robust environmental monitoring, and well-defined in-process testing to minimize batch risk. A reliable fill finish services CDMO also plans for batch-to-batch consistency through validated cleaning, changeover controls, and clear deviation and CAPA management to support regulatory compliance.
What critical factors need to be considered while doing fill finish development?
In fill finish CDMO development, the most critical factors include formulation compatibility with the primary container, protein or molecule stability during processing, sterility assurance strategy, and control of particulates and extractables/leachables. Fill finish development services also focus on defining acceptable process windows for filtration, filling, mixing, and hold times to avoid aggregation, potency loss, or pH drift. Additional critical factors include container-closure integrity, accurate dose delivery, and a scalable process design that can move smoothly from clinical to commercial manufacturing. A strong fill finish development services plan reduces late-stage surprises and improves overall manufacturability.
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