Alcami Corporation

Alcami Corporation

Recent Posts by Alcami Corporation:

Food Studies 101

Alcami’s scientists have substantial experience designing and executing food studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms. 

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients. Geriatric, pediatric, and patients suffering from gastroesophageal reflux disease are often administered pharmaceuticals mixed with food or liquids due to difficulty swallowing tablets or capsules. For immediate release, enteric coated, modified release, or extended release dosage forms, a food study is required to evaluate whether the alternate route of administration impacts the therapeutic dose.

Topics: News & Events Blogs Food Studies

Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK

WILMINGTON, N.C., August 26, 2020 - Alcami, a US-based contract development and manufacturing organization (CDMO), announced today that it is providing commercial manufacturing services for Trevena’s newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in adults for the management of acute pain severe enough to require an intravenous opioid analgesic. Alcami has provided development and clinical support for this program for several years leading up to Trevena’s approval from the U.S. Food and Drug Administration.

Topics: News & Events Blogs

Alcami RTP Expansion Nears Completion

MORRISVILLE, N.C., July 28, 2020 -- Alcami, a US-based contract development and manufacturing organization (CDMO), is pleased to announce that its 56,000 square foot expansion in Research Triangle Park (RTP), reached the first milestone of operational readiness with the start of GMP laboratory testing this month. This brand-new site with state-of-the-art design and controls became part of Alcami when TriPharm Services was acquired in January 2020. 20,000 square feet will be dedicated to microbiology, formulation development, and analytical chemistry services.  Specific investment has been made to offer industry-leading environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase 1 of the manufacturing facility in Q4 2020, which will bring the first two filling suites online and the next major milestone.

Topics: News & Events Blogs

Alcami Appoints Walter J. Kaczmarek III as Chief Executive Officer

Alcami announced today the appointment of Walter J. Kaczmarek III as Chief Executive Officer. Mr. Kaczmarek, who has over 30 years of experience in the pharmaceutical industry, will focus on advancing Alcami's next phase of strategic growth. 

Mr. Kaczmarek has served in executive roles at multiple pharmaceutical companies, including as President of the Multisource Pharmaceuticals division of Mallinckrodt Pharmaceuticals, COO of Aceto Corporation, and most recently, as President and CEO of Cosette Pharmaceuticals Inc. Mr. Kaczmarek is an industry veteran with a depth of experience spanning the entire value chain from development and manufacturing to sales and marketing.

Topics: News & Events Blogs

Alcami Continues to Strengthen Senior Leadership Team with Appointment of Quality and Regulatory Leaders

WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced further additions to strengthen its senior leadership team. Brian Dillion has been appointed to the role of Vice President of Regulatory Affairs and Quality Assurance and Jacquelyn Uribe has been appointed to the role of Vice President of Quality Operations. “Jacque and Brian bring broad compliance expertise with a track record of success upholding the rigorous standards required by both customers and regulators in high growth environments,” commented Chief Financial Officer Eric Evans.

Topics: News & Events Blogs

Alcami Appoints EVP of Drug Product Operations and VP of Laboratory Operations

WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and manufacturing organization (CDMO), today announced the appointment of Ken Domagalski and Elliott Franco to their Senior Leadership Team. Ken Domagalski has been appointed to the role of Executive Vice President of Drug Product Operations and Elliott Franco has been appointed to the role of Vice President of Laboratory Operations.

Topics: News & Events Blogs

Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions."

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

Topics: News & Events Editorials Parenteral Manufacturing Blogs

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

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

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