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Catherine Hanley

Recent Posts by Catherine Hanley:

Editorial: Overcoming the Opioid Overdose Crisis

Alcami  recently contributed to an article in the Greater Wilmington Business Journal titled, "Overcoming the Opioid Overdose Crisis."

Our community has come together, like many others, to combat the opioid crisis. Several local agencies have rallied to create impactful community resources. A 2016 survey by Castlight, which listed Wilmington, NC as the #1 city for opioid abuse in the United States, was a wake-up call to the severity this community has been affected by opioid-related fatalities and hardships. At Alcami, we work with our clients to develop abuse deterrence medicines to help combat this nationwide epidemic that hits home, even here in Wilmington.

Topics: Thought Leadership Abuse-Deterrence Editorials

Video: Extractables and Leachables

Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality Research Institute (PQRI), and several other industry consortia have developed guidelines and best practices for these extractables & leachables studies.

Alcami has specialized knowledge of the most common materials of construction such as platinum-cured silicon, halobutyl rubber, cyclic olefins, polyethylene terephthalate (PET), polyvinyl chloride (PVC), and other elastomers. Vial and stopper configurations, spray pumps, and intravenous (IV) bags are among the most common packaging system components we evaluate. We welcome all routes of administration, including the more challenging prefilled syringes, blow-fill sealed vials, and laminated cans.

Topics: Company News Extractables & Leachables Analytical Development Drug Product Extractables Studies Videos

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

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

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

Editorial: Fuelling Pharma's Innovation Engines

Alcami President & Chief Executive Officer Dr. Stephan Kutzer recently took part in an interview for Manufacturing Chemist titled "Fuelling Pharma's Innovation Engines." 

According to Stephan, small and mid-size pharma and biologics companies are the innovation engines of the industry. “Each year, the number of new INDs and NDAs increases and we anticipate this trajectory to continue. We see more than 5000 clinical introductions on an annual basis. Cancer treatments are a particular area of focus for many of our clients and we expect our pipeline for these therapies to grow within the next 5 years. Our target accessible market is around $8 billion.”

KR: How does Alcami plan to grow with the industry?

SK: We have strategically invested in capability extensions and operational excellence initiatives to better meet industry demand. At our Germantown (Wisconsin, USA) Center of Excellence for API development, scale-up and commercialisation, we have supplemented our existing pipeline with HPAPI suites and controlled substance capabilities.

Topics: Company News Thought Leadership Editorials

SCIENTIST SPOTLIGHT: February 2019

Name: Bee Fread
Alcami Site: Durham, NC

How long have you been with Alcami?
I have been with Alcami since December 2015.

What is your role? 
I am a supervisor of the biotech team at Alcami’s Durham, North Carolina site.

What is the most rewarding part of your job?
The most rewarding part of my job is working with my team and collaborating with colleagues in other departments to overcome challenges and work together to meet client commitments.

Topics: Alcami Voices