Durham, NC (USA) – October 8, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster testing results to clients. Alcami invested in the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Environmental protection, sustainable conservation, and natural habitat preservation remain key components of Alcami’s community outreach activities, and for the third consecutive year, company volunteers collaborated with Wisconsin Department of Natural Resources (DNR) trail coordinators and park superintendents to improve and renovate the Pike Lake Unit of the Kettle Moraine State Forest – one of the Wisconsin State Park System’s most popular destinations.

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.

Alcami will support your animal health products, both companion and livestock, 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. 

Alcami joined the nation in remembering and honoring fallen members of the U.S. Armed Forces this Memorial Day with a donation to the Purple Heart Foundation and a strong public showing of support for longtime Alcami employee and Vietnam veteran, Herman Anthony.

In a special tribute to the brave men and women who sacrificed their lives in service to our country, Anthony was invited by the Milwaukee Brewers to participate in a May 26 ceremony on the Miller Park playing field during the national anthem.

Alcami continues to make science, technology, engineering, and mathematics (STEM) education and training initiatives a priority in 2019, this time partnering with Homestead High School in Mequon, Wisconsin, to support the school’s growing robotics club. The company has agreed to sponsor Homestead’s 2019 competitions and demonstrations, which will help its club purchase new computers and 3D printers. On average, teams invest approximately $4,000 to build a robot from the ground up and participate in competitions.

Students 2 Science (S2S) is a New Jersey-based nonprofit committed to inspiring and educating elementary, middle, and high school students to pursue careers in science, technology, engineering, and mathematics (STEM). Through strategic partnerships between businesses, institutions of higher education, district leadership, and workforce-readiness agencies, S2S provides students with real life laboratory problem-solving experiences led by scientific professionals using modern technology and instrumentation. S2S’s V-Laboratory educational program enlists corporate partners such as Alcami to serve as in-class mentors and help introduce students to the broad spectrum of STEM careers available to them.

Alcami’s St. Louis, Missouri Center of Excellence for advanced analytical testing was issued a Certificate of Compliance by the European Medicines Agency (EMA) Tuesday, April 23, 2019, following the facility’s recent successful Good Manufacturing Practice (GMP) inspection. Certification confirms the site is compliant with GMP laboratory storage and testing practices, and enables the laboratory to process more commercial products for the European Union (EU). The outcome reflects the company’s unwavering commitments to quality, reliability, responsible operations, and strict adherence to regulatory compliance.

Alcami employees, their families, and friends celebrated Earth Day 2019 by cleaning up green spaces, beaches, waterways, sidewalks, and streets in the company’s local communities. More than 30 volunteers participated in this year’s preservation efforts, including cleanups at Wrightsville Beach, Carolina Beach, and Isle of Palms Beach, near Wilmington, North Carolina and Charleston, South Carolina; business park and nature trail litter removal in Germantown, Wisconsin; and growing new plant life in Durham, North Carolina. Combined, these efforts will protect native wildlife and enhance public gathering places for all to enjoy.

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.