The most effective way to stop the epidemic of opioid dependence is to eliminate the use of these highly addictive drugs after surgery. This was the goal of Pacira Pharmaceuticals, a specialty pharmaceutical company focused on the development of non-opioid products for postsurgical pain control, when it developed its injectable suspension, EXPAREL®.
The idea of thinking in terms of “operational excellence” is a relatively new idea for the biopharmaceutical industry. The enormous uncertainty associated with bringing a biological drug product from discovery to approval almost precludes the thought of forward-thinking in terms of what makes a quality product, especially during early-stage development. However, extensive product knowledge is gathered during early development, and crucial decisions are made in terms moving the science forward to generate the data required to meet your business objectives.
In recent years, we have witnessed a meteoric rise in clinical studies of cancer immunotherapies, catapulting immuno-oncology into one of the fastest growing and dynamic areas in pharmaceutical development today.
Protein crystals have shown the potential to address many of the issues associated with high concentration/high viscosity solutions. While formulation and delivery challenges exist with crystallized formulations, they are not insurmountable. With access to the right level of expertise and experience, a company can manufacture its product using crystallization, thereby increasing patient compliance by offering an easier and faster form of drug delivery.
This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.
SIGA Technologies, Inc. (SIGA) , a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, announced completion of enrollment and dosing in the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX (tecovirimat), for the treatment of orthopoxvirus infections