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SCIENTIST SPOTLIGHT: July 2019

Name: Shakia Carlos-Barr
Alcami Site: Wilmington, NC

How long have you been with Alcami?
I joined Alcami in May 2018 as an intern, before transitioning to a full-time position in December 2018. 

What is your role? 
Assistant Scientist, Formulations Development-Parenterals

What is the most rewarding part of your job? 
The most rewarding part of my job is knowing that our work gives hope for a better life to patients and their loved ones. In addition, we gain valuable on-the-job knowledge and experience to make us better scientists. This, in turn, helps us develop more innovative solutions that will save lives and lead to higher quality of life for patients worldwide.

Topics: Alcami Voices

Introduction to Quality by Design

Since Joseph Juran’s concept of Quality by Design (QbD) was first adopted by the US Food and Drug Administration (FDA), the pharmaceutical industry has been interpreting its concepts into a variety of approaches for implementation. At Alcami, our QbD approach considers evolving global regulatory guidances with a collaborative fit-for-purpose and pragmatic approach that can evolve throughout the lifecycle of the product. QbD starts from day one in modern product development, culminating in a chemistry manufacturing controls (CMC) package that maximizes every opportunity for a successful regulatory review and approval. The value of this approach is simple: design of robust processes for the consistent production of safe and effective products for our patients and long term cost savings for our partners through improved yields, reduced deviations, and efficient change management.

The QbD process for product development is intended to build quality into pharmaceuticals based on characteristics that define safety and efficacy. Critical quality attributes (CQAs) – specific physical, chemical, biological, and other properties – may impact product safety and efficacy and can be managed by identifying critical process parameters (CPPs) through the use of risk management tools and controlling them within the proven acceptable process design space.

Topics: Thought Leadership Regulatory Compliance Manufacturing Development Drug Product

Case Study: Abeona Therapeutics

Abeona Therapeutics, Inc. is a fully-integrated gene and cell therapy company at the forefront of the rapidly-advancing field of genetic medicine. Their late-stage candidate, EB-101, is an autologous, ex-vivo, gene-corrected cell therapy poised to enter a Phase 3 clinical trial for Recessive Dystrophic Epidermolysis Bullosa (RDEB).

Read this case study to learn how Alcami's extensive experience with small and large molecule development services, regulatory compliance, and specialty techniques helped

Topics: Resource Center Regulatory Compliance Biologics Analytical Testing Analytical Development Orphan Drugs

SCIENTIST SPOTLIGHT: June 2019

Name: Devon Dodd
Alcami Site: Wilmington, NC

How long have you been with Alcami?
I've been part of the Alcami team since November 2017.

What is your role? 
Formulation Development Scientist - Parenterals

What is the most rewarding part of your job? 
I would say it's two-fold. First, delivering new drugs to patients to improve quality of life or to save lives just never gets old. We're not a big pharmaceutical company, but we touch so many lives– and that is both exciting and humbling. Second, we partner with clients as close-knit teams to deliver the best possible products we can. I really enjoy the journey with clients, from proof of concept to market delivery. 

Topics: Alcami Voices Parenteral Manufacturing