Aurigene offers downstream process development services for biologics programs across different stages of development. Our teams support clients with downstream development, analytical alignment, technology transfer, and manufacturing readiness for a range of biologic modalities.
We work across monoclonal antibodies, bispecifics, biosimilars, peptides, and complex biologics. Our aim is to help clients build downstream processes that support product quality, stage-appropriate development, and smooth progression into later manufacturing stages.
Our Custom Services
- Downstream development
Supports biologics programs through downstream process development across multiple molecule types, including mAbs, bispecifics, biosimilars, peptides, and complex biologics. - Technology transfer to manufacturing
Supports transfer of developed processes into manufacturing as part of the broader tech transfer and manufacturing workflow highlighted in the deck. - Integration with formulation development
Works in coordination with formulation development, which is presented in the deck as part of the end-to-end biologics development offering. - Integration with drug product development
Connects downstream activities with drug product development covering liquid and lyophilized presentations, including vial and prefilled syringe formats. - Integration with analytical development
Aligns downstream work with analytical method development and product quality assessment supported by chromatographic, CE, spectroscopy, spectrometry, and bioanalytical capabilities. - Stage-appropriate qualification support
Benefits from analytical support with stage-appropriate qualification in line with ICH Q14 and Q2(R2) guidelines, as described in the deck. - Method transfer to QC and validation support
Connects with analytical method transfer to QC and validation workflows that support later-stage development and manufacturing readiness. - Product quality assessment support
Supports downstream development through analytical evaluation of identity, assay, product-related variants, process-related impurities, excipients, and general characteristics. - Stability-linked downstream support
Interfaces with formulation and analytical studies that include freeze-thaw, accelerated, stress, and in-use stability evaluation. - Support for clinical and later-stage programs
Fits into broader biologics development workflows that extend into clinical manufacturing for drug substance and drug product.
Supported Modalities
Our downstream process development services support multiple biologic formats such as:
- Monoclonal antibodies
- Bispecific antibodies
- Biosimilars
- Peptides
- Complex biologics
These capabilities allow us to support a range of downstream development needs across different molecule classes and program stages.
Downstream Development Capabilities
Our downstream development offering is part of a broader end-to-end biologics platform. The deck positions downstream development alongside upstream development, formulation development, analytical and bioanalytical support, and technology transfer.
This integrated environment helps programs move forward with stronger continuity across development stages and better alignment between process, product quality, and manufacturing expectations.
Analytical and Product Quality Support
Our downstream services are supported by extensive analytical and bioanalytical capabilities. The deck highlights method development support across chromatographic, CE, spectroscopy, spectrometry, and bioanalytical platforms, along with stage-appropriate qualification and validation support.
The analytical framework includes support for purity and impurity methods, charge and size variant analysis, active ingredient identification, identity, assay, product-related variants, process-related impurities, excipients, functional assays, and general characteristics such as pH, osmolality, particles, appearance, and fill volume.
Integration with Formulation and Drug Product Development
Downstream development does not operate in isolation. The deck supports close linkage with formulation development and drug product development, including liquid and lyophilized drug product presentations, high-concentration development, pilot-scale filling, and presentation formats such as vials, prefilled syringes, and auto-injectors.
This broader setup helps ensure that downstream activities remain aligned with the needs of later product development stages.
Why Aurigene Downstream Process Development Services?
Support across multiple biologic modalities
Downstream development within an integrated biologics environment
Strong linkage with analytical and bioanalytical capabilities
Alignment with formulation, drug product, and tech transfer functions
Support for stage-appropriate development and later manufacturing readiness
End-to-end biologics capabilities that help improve continuity across programs
Virtual Tour
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
-
April 21, 2026
H2SO4-SiO2 catalyzed synthesis, in silico and in vitro evaluation of quinazoline-based fused tetracyclic derivatives as new inhibitors of PDE4B
The 6,6a-dihydro-5H-isoquinolino[2,3-a]quinazoline-5,7,12-trione (DIQT) derivatives (that belong to the quinazoline-based fused tetracyclic class of compounds) though known in the literature, their biological properties have not been explored previously. In the current study, we have explored the phosphodiesterase 4B (PDE4B, an important target for the identifica...
Read More -
January 31, 2025
Development and assessment of a Bcs class II - SGLT2 (Sodium Glucose Cotransporter 2) inhibitor drug in the form of solid lipid Nanoparticles by selecting different lipids, co-surfactants, and manufacturing techniques
Drug Delivery System (DDS) has been used successfully in the past few decades to cure illnesses and enhance health because of its improved systemic circulation and ability to regulate the drug's pharmacological action. As pharmacology and pharmacokinetics advanced, the idea of controlled release emerged, demonstrating the significance of drug release in assessing...
Read More -
January 31, 2025
Development of novel paullone-based PROTACs as anticancer agents
Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
Read More
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.
Leaving already?
Don't forget to join us at
CPHI Worldwide 2023.
October 24th-26th, 2023 | Barcelona, Spain
Get ready to accelerate your drug’s journey to the market