• Knowledge Hub
  • News & Events
  • Careers
  • Contact Us
CatSci Logo

  • Home
  • Who we are
  • What we do
    • Early Development
    • Late Development
  • Digital Walkthrough
☰
  • Home
  • Who we are
  • What we do
    • Early Development
    • Late Development
  • Digital Walkthrough

  • Knowledge Hub
  • News & Events
  • Careers
  • Contact Us
We're hiring!

Late Development

Enabling end-to-end drug substance development from Phase II and Phase III, right through to product launch and beyond.

Process Design and Development

Our highly qualified technical team have an in-depth understanding of the multi-faceted challenges surrounding process research and development, allowing them to respond to your needs and provide perfect-for-purpose design and development solutions. Check out our whitepaper on process development here.

Process Design and Development

Our highly qualified technical team have an in-depth understanding of the multi-faceted challenges surrounding process research and development, allowing them to respond to your needs and provide perfect-for-purpose design and development solutions.

  • Process familiarisation
  • Knowledge gap assessments
  • Process optimisation and scale-up
  • Process development and optimisation
  • Process understanding and robustness
  • Commercial route options / ideation
  • Process invention
  • Kinetics / modelling
  • Experimental design – DoE, PCA
  • Proof of concept
  • Demonstration batches (incl. OEB-4)
  • Tech transfer for manufacture
  • Process safety

CatSci are experts in handling knowledge and technology transfer and can work efficiently with you and your preferred manufacturing partners, to ensure you reach your project objectives. Check out our whitepaper on experimental design here.

Process Definition

Process Definition

CatSci are experts in handling knowledge and technology transfer and can work efficiently with you and your preferred manufacturing partners, to ensure you reach your project objectives.

  • Manufacturability
  • Design space modelling / digital twins
  • PAR
  • QbD – CQAs, CPPs
  • Specifications
  • Process validation / registration
  • Manufacturing control strategy
  • Registered starting material (RSM) strategy
  • CoGs
  • Knowledge transfer
CatSci fume hood

Sustainability

CatSci is at the vanguard of green chemistry and can be trusted to develop not only economically, but also environmentally sustainable manufacturing processes. Check out our case study on solubility data-driven workup design here.

Sustainability

CatSci is at the vanguard of green chemistry and can be trusted to develop not only economically, but also environmentally sustainable manufacturing processes.

  • Green chemistry
  • Predictive and cumulative PMI
  • Analytical method greenness score (AMGS)
  • iGAL calculation
  • Process input classification (impact ratios)
  • Holistic lifecycle assessment

We truly care about the outcomes of your drug substance development projects even after launch. Through our continuous improvement and technical stewardship strategies, we can support you as product and process knowledge grows and new technologies emerge. Check out our whitepaper on developing a DKR for a generic API here.

Rotary evaporator

Lifecycle Management

Lifecycle Management

We truly care about the outcomes of your drug substance development projects even after launch. Through our continuous improvement and technical stewardship strategies, we can support you as product and process knowledge grows and new technologies emerge.

  • 2nd gen processes
  • Next gen processes
  • Continuous improvement
  • Technical stewardship

Analytical Excellence

The Analytical Project Lead collaborates with our customers to understand your specific goals and ensure perfect-for-purpose analytical methodology. Identification of impurities is augmented with robust measurement and proposed controls.

Analytical Excellence

The Analytical Project Lead collaborates with our customers to understand your specific goals and ensure perfect-for-purpose analytical methodology. Identification of impurities is augmented with robust measurement and proposed controls.

  • Batch analysis (non GMP)​
  • Method qualification and Robustness studies (AMQBD) ​
  • Measurement of trace genotoxic impurities​
  • Detailed reaction understanding and data visualisation​
  • Propose analytical controls for potential CQAs

Throughout late development, we keep on top of all requisite science and technology advances to ensure that we can best address your increasingly critical project demands. As such, we help you to create small molecule therapeutics in a safer, greener and more cost-effective way. Check out our case study on the development of a late-stage Buchwald amination here. 

CatSci scientist

Enabling Science

Enabling Science

Catalysis

  • Research, development & optimisation of catalytic processes
  • Statistical experimental design (DoE, PCA)
  • Advanced data science & visualisation techniques
  • Reaction profiling and kinetics
  • Manufacturability and process improvement
  • Metal control / removal

Material Science

  • Extensive polymorph investigation
  • Critical process parameter definition
  • API step control strategy
  • Impurity rejection studies
  • Bulk density control for formulation manufacturability
  • Milling and micronisation process definition

 

CatSci scientist

Early Development

Learn more about our Early Development Services.

CatSci fume hoods

Knowledge Hub

Check out our case studies, postcards and more in the Knowledge Hub.

CatSci scientists fume hood

Contact us

Get in touch to find out more or discuss your project objectives.

  • Home
  • Who we are
  • What we do
    • Early Development
    • Late Development
  • Digital Walkthrough
  • Knowledge Hub
  • News & Events
  • Careers
  • Contact Us

Stay in Touch

Sign up
  • Safety, Health & Environment
  • Privacy Policy

© 2011-2021 CatSci Ltd. All rights reserved.
Registered in England & Wales.
Company No. 07466141.

Cookies

This site uses cookies: Find out more.