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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 Videos

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 Analytical Testing Analytical Development Packaging Drug Product Parenteral 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

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 Editorials

Video: Alcami's Oral Solid Dose Manufacturing

Your Manufacturing Milestones Matter.
Specialized to manufacture oral solid dose (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. Our cGMP manufacturing technologies, including low/high shear granulation and fluid bed drying capabilities, are arranged in flexible suites to support novel, advanced, and complex projects. 

In addition to OSD development and manufacturing, Alcami’s in-house analytical, stability, and packaging services provide an integrated and custom-tailored offering to help your product reach patients sooner.

Topics: Company News Oral Solid Dose Drug Product Videos

Alcami STEAM Outreach Efforts Aim to Inspire Students, Advance Workforce

Alcami expanded its Science, Technology, Engineering, Arts, and Math (STEAM) education initiatives this fall with three specialized outreach events designed to encourage high school and college students to pursue careers in chemistry, engineering, and other STEAM fields. 

On October 30, 2018, Divine Savior Holy Angels High School (DSHA) students got a behind-the-scenes look at Alcami’s Germantown, Wisconsin active pharmaceutical ingredient (API) Center of Excellence, as part of the company’s ongoing efforts to promote women in STEAM careers. The all-girls engineering class toured the campus, met with key female company leaders, and learned about potential career paths through interactive presentations.

Topics: Company News Alcami in Action

Alcami Employee Recognized with Honor Flight

The nonprofit Honor Flight Network honors America’s military veterans for their sacrifices by transporting as many of them as possible to see the Washington, D.C. memorials of the wars they fought in, at no cost to them. Alcami employee and Vietnam veteran, Herman Anthony, was recently selected for an Honor Flight, and was accompanied by Milwaukee Brewers all-star relief pitcher, Corey Knebel. Herman received a hero’s welcome at the Milwaukee airport from Alcami colleagues, friends, family, and the general public. He recently spoke with Alcami's Marketing & Corporate Communications team to discuss his experience.

Topics: Company News Alcami in Action

Alcami President & CEO Elected as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association

Stephan Kutzer, Ph.D., President & CEO of Alcami Corporation, has been elected to serve as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT) beginning November 1, 2018. Together with the ten other members of DCAT’s Board of Directors, Dr. Kutzer will help develop and guide the organization’s strategic plan in a manner to best serve the organization’s 500+ member companies.

Topics: Company News

Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). MDGH utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical approval deadlines.

Topics: Company News Analytical Testing Development Analytical Development Drug Product

Alcami and UNCW Awarded Biomanufacturing Workforce Development Grant

Project Call 1.0 Proposal Selected by NIIMBL Governing Committee

Durham, NC (USA) – August 30, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, and the University of North Carolina Wilmington (UNCW), North Carolina’s globally-minded research and development university, today announce they have been awarded an educational grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), an organization comprised of companies, educational institutions, nonprofits, and state governments dedicated to accelerating biopharmaceutical manufacturing innovation, developing industry standards, and educating and training a pipeline of skilled workers for the field’s abundant well-paying jobs. The grant will fund the UNCW program “Partnership for Workforce Development in the Biopharmaceutical Industry,” which will be co-developed and taught by Alcami subject matter experts.

Topics: Company News Alcami in Action