We have a strong track record in process optimization and robust process development of peptide molecules. Our team is highly experienced in handling all forms of peptide synthesis viz. solid, solution or hybrid phase peptides at our R and D centers in Hyderabad and Bangalore.
We have a dedicated peptide lab to support peptide synthesis, downstream purification, isolation and lyophilization.
As one of the leading CDMO, we have a state-of-the-art analytical laboratory for impurity characterization and profiling based on spectral methods.
We have one of the largest facilities to manufacture high-throughput synthesis of a wide variety of standard and complex peptides. We can manufacture various types of peptide classes with linear peptides up to 40 AA, conjugates of peptides such as small molecules, lipids, carbohydrates, and PEG. Cost effective LPPS approach for small peptides or linkers. We have expertise in process optimization and robust development for commercial manufacturing.
Our advanced technology with modern infrastructure enables us to produce up to 2 kg of linear and branched chain peptides. We provide peptide manufacturing services from our state-of- the-art manufacturing site in Vizag. The site is inspected by major regulatory bodies such as the US FDA, MHRA, and PMDA.
Class of Peptides We Handle
We can handle a wide range of peptides classes such as:
- Linear and branched chain peptides up to 40-mer AA (Natural and unnatural).
- Derivatives of peptides viz., small molecules/ carbohydrate/ PEG
- Peptides with multiple disulfide bridges, head-to-tail cyclization, and side-to-side cyclization
- Stappled, fluorescent and dyes.
- Cysteine rich peptides, lactam bridged peptides.
- Expertise in LPPS, SPPS and hybrid approaches
Lab Infrastructure to Support Peptide Development
Synthesizers
- Cost-effective LPPS approach for small peptides/linkers
- Manual reactors ranging from 100 mL to 10 L capacity (SPPS)
- CS Bio 936S: Automated peptide synthesizer fits for feasibility, optimization studies, pilot studies, and scale-up activities (1 to 5 L).
- CEM Automated Microwave Peptide Synthesizer-2 nos.
Lab -scale purification
- 3 preparative reverse phase HPLCs
- 1 MPLC flash system 250 mL/min pump capacity
- 1 Akta explorer ion exchange chromatography
- 1 Aktaprime plus ion exchange chromatography
- Gel permeation chromatography columns
Isolation techniques
- Crystallization
- Precipitation
- Lyophilization
- Virtis programmable tray of 3 L capacity
- Virtis benchtop of 1.5 L capacity
- Membrane filtration technology
- Tangential Flow Filtration (TFF) 1 kDa, 10kDa, and above
Analytical equipment to support peptide development
- LCMS, GC-MS, LC-Tof, LC Orbitrap, MALDI Tof instruments for characterization
- Multi-angle Light Scattering Detector (MALS)
- Circular Dichroism (CD) analysis for peptides
- 600 MHz nuclear magnetic resonance spectrometry
- Charged Aerosol Detector (CAD) for HPLC
- Amino acid analyzer with post-column derivatization
Clinical Supply Manufacturing
For your clinical supplies and commercial manufacturing needs, we provide peptide manufacturing services from our state-of-the-art manufacturing sites in Visakhapatnam. Both these sites are inspected by major regulatory bodies such as USFDA, MHRA, PMDA etc. Our facilities are equipped with microwave assist technology, liberty pro automatic synthesizers, and fully automated ion exchange purification systems.
Equipments for Peptide Synthesis
- Automated peptide synthesizer (80-160 L)
- Liberty pro peptide synthesizer (25 L)
- Microwave assisted peptide synthesizer
- Hastealloy ANFDs of 1m2 capacity for closed loop filtration operations
- Tangential flow filtration
- Separate peptide block (PB – 16) dedicated to peptides & polymers
Peptide Purification and Isolation
- Preparative RP-HPLC (150 to 600 mm diameter column, flow rate ranging from 3.3 to 20 LPH) with PAT blending technology.
- Fully automated ion exchange resin systems
- Freeze dryer – 100 L capacity (tray)
- Class 100K clean room area with Lyophilizers
Impurity Profiling and Characterization
- LCMS, GC-MS, LC-Tof, LC Orbitrap, MALDI Tof instruments for characterization
- Multi-angle Light Scattering (MALS) detector
- Circular Dichroism (CD) analysis for peptides
- 600 MHz nuclear magnetic resonance spectrometry
- Charged Aerosol Detector (CAD) for HPLC
- Amino acid analyzer with post-column derivatization
Why Aurigene Pharmaceutical services?
Extensive knowledge in developing & manufacturing hundreds of complex pharmaceutical products
Seamless integration from discovery to manufacturing
Capabilities across a wide range of peptide molecules
Large manufacturing capacities with automatic synthesizers
Rethink processes to ensure better quality in shorter timelines
Apply new science and technologies, to reduce costs or risk and add innovation
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Resources
NOVEMBER 16, 2023
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Peptide Development and Manufacturing
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