Development by Design

Development by Design is Hovione’s proven spray-dried dispersion scale-up and tech-transfer methodology.

 

Development by Design is Hovione’s proprietary methodology which relies on the use of historical process knowledge, scale-independent correlations developed at the lab-scale and modelling tools to minimize the resources / API requirements to develop an amorphous solid dispersions spray drying process on the large scale equipment.

Hovione has an unmatched experience in spray drying which that allowed it to understand the fundamentals of this technology and build mathematical models for prediction of critical quality attributes of spray dried materials. In particular, the impact of thermodynamic behaviors, changing process conditions, drying kinetics and specific process parameters on particle attributes such as size, shape and morphology were modeled. By combining our modeling capabilities with this extensive prior knowledge, it is now possible for Hovione to closely correlate laboratory conditions to those that will be attained at large scale equipment. As a result, the time and material needed to establish an effective commercial scale spray drying process are significantly reduced. 

Development by Design allows to:

  • Reduce expense of resources (API and time) during development:
    • Rather than tens to hundreds of Kg of API, as little as 30g may be required for testing and customers can have a commercial-scale process without tests at large scale;
  • Leaner development through effective knowledge management;
  • Strong science & process understanding (thermodynamics, atomization, particle formation) that make scale up a straightforward and predictable task;
  • Assured results - Hovione assures results within offered project scope.

Development by Design is a phase appropriate approach that allows to progress along early clinical stages without incurring in expensive development costs of doing experimental work in large scale equipment. Only when there is less clinical risk are experiments ran at the intended commercial scale to define the design space and process intensification if needed.

DbD-methodology

 

The table below shows the impact of Hovione’s Development by Design approach to Spray Drying process development:

 

 

1st QbD Project(2005-2010)
(2005-2010)

2nd QbD Filling
(2007-2013)

Today Under
DbD**

# Runs at full scale ~270 ~60 ~9
Material needed ~900 kg
(~$ 9 MM*)

~200 kg
(~$ 2 MM*)

~40 kg
(~$ 0.4 MM*)
Days at full scale ~4 months ~4 weeks ~4 days
*Assumed $10,000/kg as reference; **DbD = Development by Design

 

These results demonstrate that Hovione has been able to combine its modeling skills and extensive process knowledge to accelerate the development and commercialization of drugs. Consequently, helping customers to more quickly and cost-effectively deliver needed drugs to patients.

Related files

Article - Accelerating approval and reducing costs of spray dried drugs through development by design
pdf (2.05 MB)
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2016 PBP Meeting - Development by Design: An approach to spray drying process development
pdf (889.56 KB)
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