Process Development
and Technology Transfer Services
As your trusted and reliable CDMO partner, we offer services ranging from clone selection and characterization to process development, analytical and bioassay development across different platforms and modalities. Our strong technical expertise with highly capable and flexible technologies, can help you accelerate your programs with significant flexibility and competitive cost structure.
Technology Transfer
We bring deep expertise and experience in successful technology transfers with strong protocols, high quality standards and documentation practices at every step of the process. Our structured approach covering gap analysis and robust risk mitigation plans helps in seamless technology transfers from one site to another.
We collaborate with clients for effective knowledge and technology transfer to Stelis’ process development/pilot scale, scale-up to intended manufacturing scale.
- Our highly streamlined and efficient tech transfer process enables rapid and reliable clone selection, process development and scale-up
- Process optimization using high throughput systems and DoE approaches to meet yield and product quality targets
- Seamless tech transfer to cGMP manufacturing using qualified scale-down models to de-risk process scale-up and ensure robust manufacturing outcomes
Clone Selection and Characterization
We can help you deliver with effective timelines in seamless technology transfer of cell lines, Research Cell Banks (RCBs) and Master Cell Banks (MCBs).
We collaborate with you to provide customized support with competitive cost structure to help you deliver on:
- Clone screening and selection to optimize yield
- Preparation and characterization of cell banks (Working Cell Banks)
Process Development
Our technology, flexibility and tailormade solutions for varied client needs
We use single-use and hybrid systems to manufacture products for mammalian, microbial, viral vector and other platforms to suit your needs. Our process development laboratories are highly equipped for early-stage development and process intensification operations. Through our technical expertise and infrastructure, we also support late-stage process development activities, like scale down modelling, process characterization and other commercial scale processes.
Stelis ensures execution of all these activities from ab initio to support process by maintaining high-quality standards and excellence with competitive cost models. Our tailored approach enables our clients in achieving the desired and consistent product quality within the timelines and as per the global regulatory requirements.
We offer services for Drug Substance and Drug Product Development
- Early and late-stage development for all biologics modalities and dosage forms
- Development to ensure product quality, compliance, usability and competitiveness using DoE and QbD approaches to ensure intended drug performance
- Design of primary packaging systems, based on extractable and leachable studies, to ensure a robust and commercially scalable process
Overview of Stelis Process
Development and MSAT
State of the art laboratories, ready to serve many modalities
- Seamless tech transfer of cell lines and banks (RCBs, MCBs)
- Clone screening and selection to optimize yield
- Preparation and characterization of cell banks (WCBs)
- Wide range of technologies and high throughput methodologies to support all stages of development, including method development, characterization, impurity profiling, comparability, lot release, stability and clinical assessment of wide range of biotherapeutic molecules (e.g., monoclonal antibodies, fusion proteins, recombinant proteins and peptides)
- Robust set of platform-based physico-chemical and bioassay methods for efficient product and process characterization
- Highly streamlined method transfer approaches for successful implementation and validation in Quality control labs
- Our highly streamlined and efficient tech transfer process enables rapid and reliable clone selection, process development and scale-up
- Process optimization using high throughput systems and DoE approaches to meet yield and product quality targets
- Seamless tech transfer to cGMP manufacturing using qualified scale-down models to de-risk process scale-up and ensure robust manufacturing outcomes
- Early and late-stage development for all biologics modalities and dosage forms
- Development to ensure product quality, compliance, usability and competitiveness using DoE and QbD approaches to ensure intended drug performance
- Design of primary packaging systems, based on extractable and leachable studies, to ensure a robust and commercially scalable process
