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SCIENTIST SPOTLIGHT: March 2019

Name: Czarina Carino
Alcami Site: Durham, NC

How long have you been with Alcami?
It will be my 11th year with Alcami in June.

What is your role? 
I am a scientist in the pharmaceutical development laboratory at our Durham, North Carolina site. I evaluate, develop, validate test methods, perform abuse deterrence studies, and train analysts in specialized analytical methods.

What is the most rewarding part of your job?
The most rewarding part of my job is completing and executing a test successfully– be it an evaluation, development, validation, or a special research project– because a successful execution entails a lot of things– company filing a new drug application (NDA) on time; a timely manufacture of a drug product; sharing experiences and knowledge; contributing to the site’s goals, and most of all, helping to ensure that a product delivered to the patient is safe, has integrity, and is of high quality.

Topics: Alcami Voices

eBook: Elemental Impurities

The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> with an instrument-based approach on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods were non-specific and frequently failed to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. 

Throughout this guidebook, Alcami scientists will discuss heavy metal regulations, moving to a risk-based approach, the role of risk assessment in the manufacturing process, goals and accountability, and agency-accepted testing and filing strategy for elemental impurities

 


Topics: Thought Leadership Resource Center Elemental Impurities Analytical Development

ON-DEMAND WEBINAR: The Importance of Microbial In-Use Studies

A microbial in-use (admixture) study is performed to evaluate the growth of low-level microorganisms inoculated into the diluted drug product and tested at several time points over the prescribed administration time. These studies are performed to determine if microbial growth will be supported and/or proliferate in the product during the holding period prior to patient administration in the event of inadvertent microbial contamination during product dilution. It is important to understand and comply with the timelines and deadlines surrounding these microbiological procedures. 

In this webinar, Alcami’s admixture studies expert, Brent Harlow, will guide you through the necessity of these studies and how to successfully perform them for FDA approval. 

Topics: Webinars Microbiology

Alcami Exhibiting and Presenting at CPhI North America

Alcami will be exhibiting and presenting at CPhI North America, to be held April 30 - May 2, 2019 in Chicago, IL. Be sure to stop by booth #402 and connect with the Alcami team.

Schedule a Meeting

 And don't miss the following Alcami presentations:

Topics: Events

Editorial: An Interview with Alcami

Sterile Fill Line 2Alcami parenteral experts recently contributed to an article in Pharmaceutical Outsourcing titled, "An Interview with Alcami."

As new parenteral products are introduced into the market, what are some of the challenges parenteral manufacturers have faced, and how do they solve these challenges?

If current trends hold, it is expected that new parenteral products will be increasingly complex, requiring nonstandard manufacturing technologies subjected to higher standards of regulatory scrutiny and market expectations. With the emphasis on precision medicine— an emerging approach of disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person— there will be a greater number of biologic drugs, multidrug combination products, drug device combinations, and targeted drug delivery systems introduced to the market. Parenteral manufacturing of these complex drug products will require special equipment, technologies, and control strategies. It will also require highly skilled process engineers, manufacturing operators, and quality assurance personnel. 

Take a Virtual Tour of Our Sterile Fill Line 1

Topics: Thought Leadership Editorials Drug Product Formulations Parenteral Manufacturing

ON-DEMAND ALCAMI MASTER CLASS WEBINAR: Early Phase Development of Biologics

By some estimates, the pre-approval cost of drug development is a staggering $2.5 billion per drug and takes an average of ten years from discovery to reach market. For novel therapeutics, the highest risk is during early phase development, and biologics are no different. However, biologics drug product manufacturers face some unique challenges because they are made from biological sources. Some of these challenges are batch-to-batch consistency, changing impurity profiles, and molecular instability.

Topics: Webinars Biologics

Alcami Kickstarts Biologics Enterprise to Advance Treatments for Complex Medical Conditions

Durham, NC (USA) – March 19, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today launched Alcami Biologics, the organization’s new biopharmaceutical development, analytical testing, manufacturing, and packaging enterprise. Alcami Biologics will advance the commercialization of a wide range of biological products to treat complex medical conditions with unmet needs. This comes in response to increased market demand for outsourced biological drug development services.

Topics: Company News Biologics Manufacturing Analytical Testing Development Analytical Development Packaging Drug Product Parenteral Manufacturing

Editorial: Oral Solids Endure & Evolve

Alcami recently contributed to an article in Contract Pharma titled "Oral Solids Endure & Evolve."

Contract Pharma talks with several contract service providers about the state of the oral solid dose development and manufacturing market.

The oral solid dose (OSD) development through manufacturing pipeline of products is expanding at a robust rate—even while industry watches the investment, interest and demand for biologics and biosimilars growing rapidly. There are several reasons OSDs continue to be the most popular dosage form for getting drugs to patients. In addition to being cost effective and relatively easy to make compared to their large molecule counterparts, they are most importantly, patient friendly, especially among the pediatric and geriatric populations.

Take a Virtual Tour of Our Granulation Suite

Topics: Thought Leadership Editorials Oral Solid Dose

Editorial: HPAPIs - A CDMO View

Alcami recently contributed to an article in Specialty Chemicals Magazine titled "HPAPI's: A CDMO View."

Alcami has gained extensive knowledge on HPAPI manufacturing from building new suites at its US API development and manufacturing site

Over the course of 2016-2017, global CDMO Alcami built and qualified a new facility for highly potent compounds at its facility in Germantown, Wisconsin. During the design phase, says Adam Kujath, global senior director of manufacturing science & technology, the company put considerable thought into what was needed to match its existing capabilities – it has a very diverse customer base and works with many different molecules – to market needs.

Take a Virtual Tour of Our HPAPI Suites

Topics: Thought Leadership HPAPI Editorials HPAPI Manufacturing

Connect Faster: Introducing Alcami RightNow™

Alcami is connecting with its customers faster with the launch of Alcami RightNow™, the company’s new convenient and responsive web-based live chat function.

The latest in the company’s growing customer experience enhancements, Alcami RightNow grants existing clients, prospective partners, and information seekers immediate answers to questions and quick access to materials, resources, and relevant content by directly communicating with live Alcami experts.

Topics: Company News Resource Center Alcami RightNow