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Allison Irrera

Allison Irrera

Recent Posts by Allison Irrera:

Video: High-Potency APIs

The increasing trend of using highly potent active pharmaceutical ingredients (HPAPIs) in new drug development candidates has created a tremendous demand for high containment development and production capabilities.

Alcami is a trusted partner for the development and manufacture of HPAPIs. Our Germantown Center of Excellence for API development, scale up, and commercialization provides an exceptional platform for control strategy at each phase of the development process through a series of investments targeted at infrastructure, workforce, tools, and technology. Alcami’s extensive regulatory expertise allows innovators to execute all parts of development and manufacturing in one US‐based location to support the launch of tomorrow’s medicines.

Topics: News & Events HPAPI API Videos

Video: Animal Health

Alcami will support your companion animal health products with precise attention to quality by design and process development. We have experience advancing over 50 animal health products from concept through commercialization, with services ranging from analytical support to manufacturing of active pharmaceutical ingredients (APIs), oral solid dose (OSD) products, and sterile (liquid and lyophilized) products. 

Topics: News & Events Analytical Testing Analytical Development API Drug Product Videos Animal Health

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

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

Regulatory Requirements for Early Phase Drug Product Development

Supporting a compound from discovery to clinical phases and potentially commercial phases requires an immense amount of time, energy, and money. Regulatory management is paramount during the drug development pipeline funnel, and recognizing Current Good Manufacturing Practices (CGMPs) is the foundation of drug safety and efficacy.

Every country has its own regulatory authority, responsible for enforcing rules and regulations and issuing guidelines for drug development, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products.[1]

Topics: Regulatory Compliance Drug Product Blogs

Editorial: Novel Therapies Roundtable Discussion

Alcami recently contributed to a roundtable discussion in Pharma's Almanac magazine, answering the question:

"What truly novel therapies in the earliest stages of discovery and development do you believe will have a significant impact in the future?" 

The article shares insights to this question from Alcami, along with other companies in the biologics space.

Topics: Biologics Editorials Development

SCIENTIST SPOTLIGHT: May 2019

Name: Colleen Caffarelli
Alcami Site: Edison, NJ

How long have you been with Alcami?
I joined Alcami six years ago.

What is your role? 
I am a regulatory compliance specialist II. 

What is the most rewarding part of your job?
As part of my job, I host client audits. I love meeting with our clients and seeing how the work we perform impacts their company and ultimately the patients that rely on the medications produced. Client audits provide an opportunity to see different perspectives and facilitate continuous improvement.

Topics: Blogs

Stability: Top Testing Factors You Should Consider

Stability testing is a fundamental part of the drug development process— upholding the quality of active pharmaceutical ingredients (APIs) and drug products while also providing an accurate shelf life. Through stability testing, pharmaceutical companies are able to determine the most suitable packaging and/or container closure system for the storage and distribution of drug products.

“Stability storage and testing plays a big part in the drug development process from research and development up to commercialization and beyond,” said Alcami Senior Manager of Stability Services, Scott Jedrey. “Testing throughout each phase, whether it is physical or chemical, allows data to be gathered, trended, and reviewed. Based on the data, decisions are made on whether to move forward to the next phase, which includes more testing and more patients in several clinical trials. The product must possess the purity, potency, and safety throughout each phase of the drug development process in order to obtain that very important agency approval.”

Topics: Stability Analytical Testing Blogs

Beyond the Bench: UNC Wilmington Classroom to cGMP Laboratories

Alcami and the University of North Carolina Wilmington (UNCW) have partnered on an academic program that connects education and work experiences for students pursuing scientific careers, especially in pharmaceutical sciences. This edition of the Beyond the Bench series will highlight the laboratory-based course taught at UNCW’s state-of-the-art marine biotechnology center (MARBIONC), “Current Good Pharmaceutical Quality Control Laboratory Practice,” focused on the application of Current Good Manufacturing Practices (cGMPs) in a drug development and testing laboratory.

In 2016, leaders from Alcami and UNCW met to discuss potential opportunities to work together on biopharmaceutical projects. Many of Alcami’s Wilmington employees are UNCW graduates, and Alcami has a long history working with the university on employee education programs and pharmaceutical projects. Steve Fontana, JD, from UNCW’s Office of Intellectual Property and Commercialization; UNCW Chancellor Dr. Jose V. Sartarelli, and Alcami President and Chief Executive Officer (CEO) Dr. Stephan Kutzer initiated conversations that resulted in the development of the present partnership.

Topics: News & Events Blogs

Staying Ahead of OSD Challenges

Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges must be immediately addressed to keep timelines on track. In early-stage OSD formulation development, complex solubility issues, difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API) all can lead to delays in development. During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physicochemical characteristics of a product.

Topics: Serialization Oral Solid Dose Packaging Blogs