NEWS & EVENTS

Alcami Announces Senior Leadership Appointments

WILMINGTON, NC – May 8, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Sally Langa and Kimberly McClintock to their Senior Leadership team. Sally Langa has been appointed to the role of Senior Vice President of Sales and Kimberly McClintock has been appointed to the role of Vice President of Marketing and Client Services.  

Topics: News & Events Blogs

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

Alcami Supporting Potential COVID-19 Treatment

WOODCLIFF LAKE, N.J.—April 16, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New Jersey-based pharmaceutical company, today announced that its product RYANODEX® (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA’s Coronavirus Treatment Acceleration Program (“CTAP”) to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Topics: News & Events Parenteral Manufacturing Blogs

Editorial: Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Michael Reel, director of technical services at Alcami, and Quinn McGinnis, process engineer at Alcami, recently contributed to an article in Manufacturing Technology Insights titled Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas. In the article, Reel and McGinnis discuss solutions to pharmaceutical packaging challenges through straightforward case studies.

Even well-designed product formulations can fail if it is contained in inappropriate packaging. How does one decide which packaging to use for a product?

Foremost, packaging has to protect the product from degradation and damage. Material compatibility, water activity, and dynamic vapor sorption testing, and forced degradation studies during development are key in identifiying the risks. different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered prodcuts may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves or amber-colored glass for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. These are just a few examples of the ways packaging is used to protect the product from its environment or handling. Early evaluation of the formulated product is pivotal to selecting the right mitigation strategy.

Topics: Editorials Packaging 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

Alcami Expands its Sterile Fill-Finish Capacity with Acquisition of TriPharm Services

Transaction Advances Alcami’s Strategic Plan by Adding Scale in Attractive and Growing Parenteral Markets

Alcami Investors Make Additional Equity Investment Alongside Ampersand Capital Partners to Fund Expansion

Durham, NC (USA) – January 17, 2020 – Alcami Corporation (“Alcami”), a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced it has acquired TriPharm Services (“TriPharm”), a new state-of-the-art sterile fill-finish manufacturing center located near Research Triangle Park, North Carolina. The acquisition of TriPharm follows the recently announced $17 million expansion of Alcami’s sterile fill-finish facility in Charleston, South Carolina.

Topics: News & Events Parenteral Manufacturing

Alcami Announces Sale of its Weert, Netherlands Facility

Next Step in Alcami’s Strategic Plan to Focus its Platform on High-Growth Market Segments

Durham, NC (USA) – January 8, 2020 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the sale of its preclinical and early stage active pharmaceutical ingredient (API) facility in Weert, Netherlands to MercachemSyncom, a leading mid-sized European integrated drug-discovery and development contract research organization. Terms were not disclosed. 

Topics: News & Events

SCIENTIST SPOTLIGHT: Katie Shupe

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. 

Topics: Blogs

Alcami Corporation Expanding Operations in Charleston County

Durham, NC (USA) – December 17, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced plans to expand the company’s current operations in Charleston County. The $17 million investment is expected to create 30 new jobs.

Operating in North Charleston since 2001, Alcami offers a variety of solutions tailored to small and midsized pharmaceutical and biotechnology companies. Located at 4221 Faber Place Drive in North Charleston, S.C., Alcami will add approximately 6,000 square feet to the footprint of its facility, substantially augmenting the capacity of its sterile drug product development and manufacturing operations.

Topics: News & Events Parenteral Manufacturing

SCIENTIST SPOTLIGHT: Norman Chieng

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. 

Topics: Blogs