Formulation development for biologics plays a critical role in stabilizing bio-therapeutics. Drug product development could be challenging due to complexities associated with manufacturing and dynamic regulatory aspects. We at Aurigene, provide complete end-to end solutions for development to manufacturing services. We offer service flexibility by considering the needs of the customer to support early phase and late phase development services.
Early stage development: Formulation and Drug Product development studies
- Screening of buffers: Identifying a suitable buffer environment with specific pH for the stability of biologics molecules.
- Excipient screening: Assessing the stability of the biologics molecule in the presence of excipients.
- Stress studies: Ensuring the stability of the protein in a selected formulation under freezing and thawing, thermal, agitation and UV light exposures.
- Container closure compatibility studies: Identifying a suitable container closure system for proper drug product finalization.
- Stability studies: Ensuring that critical quality attributes remain within the specification limits.
- Drug product development: Supporting the acceleration of clinical studies by developing lyophilized and liquid drug products as per study requirements.
Late stage development: Process Optimization and Evaluation for manufacturability
- Formulation robustness studies: Considering the criticality for commercializing drug products, key parameters are assessed throughout the process. Process optimization and evaluation in the manufacturing process without affecting the quality of the product.
- Drug product extension studies: Assessing the changes required in a final drug product presentation or identifying alternative presentations based on requirement.
Capabilities: State-of-the art formulation and analytical facility
High throughput methods (96-well plate assays)
- Dynamic Light Scattering (DLS)
- Differential Scanning Fluorimetry (DSF)
- Differential Scanning Calorimetry (DSC)
- Micro-Flow Imaging (MFI)
- Nephelostar
Key Analytical Methods
- Size Exclusion Chromatography (HP- SEC)
- Ion Exchange Chromatography (HP-IEX)
- Sciex PA 800 (CE-SDS)
- HPLC-CAD
- QTOF MS (Synapt & Xevo-G2 XS)
- Triple Quad MS
- DIONEX-ICS-3000
- Viscometer (m-VROC)
- Osmometer
- FT-NIR
- Karl Fischer titrator
- Low Volume Liquid particle (HIAC)
- Density meter
- Visual Inspection box
Stability
- Stability chamber (2-8 °C)
- Stability chamber (25 °C)
- Stability chamber (40 °C)
- Orbital shaker incubator (25 °C)
DP Development Process
- Lyostar Lyophilizer
- Bausch & Strobel PFS filling machine
- Bausch & Strobel Vial filling machine
- LAFU
- Peristaltic pump
DP Manufacturing
- Liquid filling line (2R to 50R vials)
- PFS filling line
- Lyophilization (15R to 50R vials)
- Single use systems
- Stainless steel systems
Why choose Aurigene?
End-to End and flexible services across the Product Life cycle
State of the art formulation development lab and manufacturing facilities
Experience in high-concentration mAbs and various Drug Product delivery platforms (Vials (liquid and Lyophilized), PFS, and auto-injectors)
Expertise in problem solving and expediting the activities at faster pace.
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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
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