Phase I & II

As you move through your Drug Development Process, finding the right partners that can support your therapeutic through the clinical stages will be extremely important.

  • scientists looking at a DNA sequence on the monitorWhat services do they offer?
  • Can they support my Phase 1 Process and Analytical Development requirements?
  • Can they support my IND filing?
  • What experience does the CDMO bring that can help me in the Early Clinical Phases?

As a partner, we bring a wide range of services and extensive experience supporting our customers from early preclinical development to getting your CMC section ready for an IND filing and supporting your manufacturing needs as you go from Phase 1 & 2  to Phase 3 to commercial readiness and commercial supply. We also offer you our Phase Appropriate expertise to help you reach your goals on time, within budget, with your strategy realized.

The Services we offer to support Early Phase Trials include:

clinical phase

  • Process Development
  • Process Optimization
  • Analytical Development
  • Preformulation Studies
  • Formulation Development
  • Toxicology Material Generation
  • IND Enabling Stability Studies
  • Long Terms Stability Studies
  • cGMP Manufacture to support Clinical Studies

As we work together, we work in partnership to understand your goals. As we embark in Process Development activities we work to understand what are the needs.

From a Process Development Perspective:

Cell Culture

  • Are you able or willing to potentially sacrifice titer for better product quality and robust reliable processing? This will determine how much is done early on.
  • Will you need material to support your toxicology studies?
  • What are the timelines leading to your IND filing? For Phase 1?
  • Is your clinical trial only going on healthy volunteers? Is this fast-tracked?

It is extremely important to understand that if a minimal Process Development approach is taken to support a Phase I process is likely to be  uncharacterized which can make it more challenging to execute or transfer.  Further development is required in most cases to be ready for Phase II manufacturing.

From an Analytical perspective:

phase 1 and 2

Glucocerebrosidase (beta-glucosidase) enzyme molecule. Deficient in Gaucher’s disease. Recombinant analog used as drug in Gaucher’s disease. Cartoon representation. Secondary structure coloring.

Will you be pursuing a minimal approach in the Analytics?

Working with your CDMO you need make sure that you will be meeting the minimum requirements to support your IND filing.

It is also important to be prepared to do additional Analytical work in order to support Phase 2 requirements, including performing Additional MS, DSC, peptide mapping and establishing the Robustness of the methods.

Have you started monitoring Physiochemical Quality Attributes early?

These attributes require careful monitoring during the early stages of strain selection and upstream development to establish physiochemical comparability. This is Particularly important when transferring processes that involve host strain changes , or moving from early phase to  late stage clinical phases.

What are your formulation needs?  How are you dosing your patients?

Taking into consideration the long term formulation goals is important for setting a successful Formulation program early on.

cGMP Release and Stability Studies

As Your Partner of Choice We Will Support You All Along The Way

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