The document outlines ten major factors critical for successful protein formulation development, emphasizing the importance of understanding each protein's unique characteristics and the relevant stresses they experience. It highlights how proteins can degrade under various physical and chemical stresses, generating different degradation products that must be addressed in formulation studies. Integrity Bio, a contract development and manufacturing organization, specializes in formulating biologics and has extensive experience with over 150 products including vaccines and proteins.

1. Ten Major Factors in Successful
Protein Formulation Development
For complete presentation visit:
http://www.integritybio.com/ScientificExpertise/WhitePapers.aspx

2. Each Protein has a Personality
• A protein’s personality contributes to
physicochemical attributes and final
drug product formulation but is difficult
to guess and/or fix without conducting
systematic research.
• When a new protein is in the
development phase, one seeks the
most effective and efficient process to
identify a formulation given the
resource, budget, and timeline.
• The ten factors that follow are critical
for developing good protein
formulations.
2

3. 1. Relevant Stresses
• Proteins are molecules of delicate • Heat, cold, agitation, shear,
three-dimensional structures that surface, freezing, dehydration, and
are made of unique primary, light are examples of relevant
secondary, tertiary, and even physical stresses.
quaternary structures. • Metal ions, destabilizing
• Different proteins may be impurities, pH, active oxygen
susceptible to different stresses species, and free radicals are
during normal use such as examples of some chemical
process, manufacturing, storage, stresses.
transportation, and delivery. • The stresses introduced for
formulation development studies
have to be relevant to what the
product will experience in real life.
3

4. 2. Major Degradation Products
• Proteins exposed to stresses
generate various forms of
degradation products.
• Physical degradation
products include aggregation,
precipitation, denaturation
(loss of active conformation),
and fragmentation.
• Chemical degradations
include oxidation,
deamidation, disulfide
scrambling, and Maillard
reaction.
• Other product specific
degradation products may
also be produced.
4

5. Remaining presentation available
at Company Website
For complete presentation visit:
http://www.integritybio.com/ScientificExpertise/WhitePapers.aspx
5

6. About Integrity Bio
• Integrity Bio is a contract development and
manufacturing organization focused on the formulation
and GMP filling of biologics.
• We have formulated over 150 biologics including
vaccines, antibodies, proteins, and peptides for more
than 75 firms.
• Integrity Bio specializes in hard-to-formulate products in
liquid and lyophilized forms.
• To learn more about our capabilities, visit
http://www.integritybio.com
• Follow us on https://twitter.com/ProteinForm
6

7. About Integrity Bio
• Integrity Bio is a contract development and
manufacturing organization focused on the formulation
and GMP filling of biologics.
• We have formulated over 150 biologics including
vaccines, antibodies, proteins, and peptides for more
than 75 firms.
• Integrity Bio specializes in hard-to-formulate products in
liquid and lyophilized forms.
• To learn more about our capabilities, visit
http://www.integritybio.com
• Follow us on https://twitter.com/ProteinForm
6