Comera SPAC Presentation Deck
Excipients Typically Used to Reduce Viscosity,
but Lack of Innovation has Plagued Industry
Despite decades of research, a lack
of effective excipients remains
Suboptimal excipients can:
Fail to reduce viscosity sufficiently
Destabilize the biologic protein
Increase injection pain
Cause other side effects
(.<)
Lack of innovation highlighted by FDA Novel
Excipient Review Pilot Program
First proposals accepted December 2021
FDA U.S. FOOD & DRUG
ADMINISTRATION
Comera
Novel Excipient Review Pilot Program
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel
Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient
manufacturers to obtain FDA review of certain novel excipients prior to their use in drug
formulations. This Pilot Program will foster development of excipients that may be useful in
scenarios in which excipient manufacturers and drug developers have cited difficulty in using
existing excipients.
Excipients are substances added to a therapeutic agent in a drug formulation to
aid in manufacturing, delivery, stability and/or patient acceptability
LIFE SCIENCES
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