BlogHeader.png

Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to a drug or biological product (drug) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation, or orphan status. For a drug to qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and US Food and Drug Administration’s (FDA) implementing regulations per 21 CFR Part 316. The FDA Office of Orphan Products Development (OOPD) evaluates the scientific and clinical data submission from sponsors to identify and designate products as promising for rare diseases or conditions.

Topics: Regulatory Compliance Drug Product Orphan Drugs Blogs

The Benefits of Establishing a Full-Time Equivalent (FTE) Program with Your Contract Service Provider

A Full-Time Equivalent (FTE) agreement is a comprehensive analytical service that grants pharmaceutical and biotech companies the flexibility, freedom, and consistent control of their outsourced laboratory programs. In this article, we will discuss the benefits of establishing a FTE program with an outsourcing partner and examine the customized solutions that are available for a broad spectrum of testing needs.

Alcami’s Extended Workbench offering is a FTE program tailored to your specific needs. An Extended Workbench program can vary in size, management approach, and scope, and is available across any pharmaceutical platform, from small molecule API to biologic drug product. 

Topics: Analytical Testing Blogs

SCIENTIST SPOTLIGHT: December 2019

Name: Katie Shupe

Alcami Site: St. Louis, MO

What is your role? 
I am a lead chemistry analyst. I assist with training and scheduling, provide guidance in the lab, and perform routine testing. 

How long have you been with Alcami?
I have been with Alcami for almost three months. 

What is the most rewarding part of your job? 
The most rewarding part of my job is helping others, whether they be my fellow chemists in the lab, or patients, who are ultimately our end customers. 

Topics: Blogs

SCIENTIST SPOTLIGHT: November 2019

Name: Norman Chieng, PhD

Alcami Site: Charleston, SC 

What is your role? 
I am a senior scientist in formulations and development. My role is to develop, formulate, and transfer the science and technology for the formulation and process into our cGMP manufacturing space. 

How long have you been with Alcami?
I have been with Alcami since March of 2019.

What is the most rewarding part of your job? 
The most rewarding part of my job is applying the fundamental science behind drug design. At Alcami, we are helping improve the quality of patients’ lives by taking a client’s product and developing a way to formulate and deliver it.

Topics: Blogs

The Importance of Secondary Packaging

There are three main types of packaging – primary, secondary, and tertiary – and it is important to understand that all levels of packaging serve specific purposes with specific requirements, in order to get products to people safely, efficiently, and consistently.

Topics: Serialization Oral Solid Dose Packaging Blogs

SCIENTIST SPOTLIGHT: October 2019

Name:Scott Reed

Alcami Site: Charleston, SC 

What is your role? 
I am a manufacturing technician with a focus on compounding and filling.

How long have you been with Alcami?
I have been with Alcami since June of 2018.

What is the most rewarding part of your job? 
The most rewarding parts of my job are taking a product from start to finish, and knowing that I had a direct part in improving the quality of life for others. 

Topics: Blogs

A 3-Minute Introduction To Rapid Sterility Testing

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. A typical sterility test has 14 full days of incubation and uses analyst observations to generate results, whereas a rapid sterility test is reduced to just five days of incubation – a 64% reduction in processing time. Rapid sterility also incorporates more sophisticated, computer-generated results, which eliminate observation bias. Alcami utilizes the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Topics: Analytical Testing Microbiology Rapid Sterility Blogs

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: Blogs

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: Regulatory Compliance Drug Product Blogs

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: Blogs