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Editorial: High-Resolution Mass Spectrometry - A Map to Biologics

An Alcami authored article will be featured in the upcoming September 2018 issue of Drug Development & Delivery titled High-Resolution Mass Spectrometry - A Map to Biologics.

INTRODUCTION
Biopharmaceutical products represent up to 20% of the total pharmaceutical market and are growing at a rate of nearly 8% annually. To keep up with this impressive growth rate, many CDMOs are making strategic investments in equipment and expertise to support analytical development and structural characterization of biopharmaceuticals in more economical and efficient ways.¹ Unlike small molecule active pharmaceutical ingredients that exist as a single chemical entity, biologics nearly always exist as a mixture of molecules. Different molecules can arise from numerous sources including N-terminal variants, post-translation modifications (PTMs), glycoforms, and degradation products. 

Topics: Biologics Editorials

Editorial: The role of DoE in early phase development

Alcami recently authored an article featured in Manufacturing Chemist titled "The role of DoE in early phase development"

Classically, the use of Design of Experiments (DoE) has been heavily leveraged in the pharmaceutical industry in late stage development to support a Quality by Design (QBD) approach to process validation

At the heart of the QbD movement is a data based understanding of the design space of your process — rather than just the empirical support of release testing — to know that the product being made is of consistently high quality. However, because of the association of QbD with expansive data generation and process validation, there is a perceived negative implication to development cost and timing. 

Topics: Editorials API

Alcami Announces Donation to Wilmington, North Carolina Fire Department

Durham, NC (USA) – June 14, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its $15,000 donation to the Wilmington, North Carolina Fire Department (WFD) to help fund IvyGene® cancer screenings for firefighters. Wilmington Mayor Bill Saffo, Mayor Pro-tem Margaret Haynes, Deputy Fire Chief Jon S. Mason, and other prominent city officials accepted the donation at an invitation-only commemorative event Wednesday, June 13, 2018, at Alcami’s Wilmington state-of-the-art advanced laboratory services and oral solid dose formulation and manufacturing facilities.

Topics: News & Events

Alcami’s Extended Workbench Supports Commercial Supply of Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)

Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announced the expanded deployment of its Extended Workbench laboratory services program to support the ongoing manufacturing and development of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). ZILRETTA is the first U.S. Food and Drug Administration (FDA) approved product from Flexion Therapeutics, Inc., a Massachusetts-based biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA). Flexion utilized Alcami’s Extended Workbench to support ZILRETTA from Phase 2 clinical trials through commercial launch and is using the program for the release and stability testing of commercial batches.

Topics: News & Events Analytical Testing Development Analytical Development Drug Product

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017.  Ultimately, the FDA recognized the massive undertaking of such a requirement and extended the deadline to November 26, 2018.

Alcami began implementing serialization in 2015 to achieve the aggressive timelines and develop the necessary documentation needed to meet compliance.

This case study shows how Alcami has successfully transferred clients into the new serialization program.

Topics: Regulatory Compliance Serialization Drug Product Case Study

Alcami to Become Industry Leading Platform CDMO Following Acquisition by Madison Dearborn Partners

Durham, NC (USA) – June 1, 2018 – Alcami Corporation (“Alcami” or the “Company”), a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announced it has reached an agreement to be acquired by Madison Dearborn Partners, LLC (MDP). MDP, a leading private equity firm based in Chicago, will acquire a majority ownership position in Alcami from existing shareholder Ares Capital Corporation (NASDAQ: ARCC) (“Ares Capital”). Alcami’s management team, led by Chief Executive Officer, President, and Chairman, Dr. Stephan Kutzer, will continue to guide the Company. The transaction is expected to be completed in the third quarter of 2018, pending customary closing conditions.

Topics: News & Events