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WEBINAR: Successful Application of the New Elemental Impurities Regulation

Join Alcami and the Division of Pharmacy Professional Development at UW-Madison on Thursday, August 2, 2018 for a webinar: Successful Application of the New Elemental Impurities Regulation.

The recent changes to the elemental impurities regulation guidelines increase the level of control necessary in testing for heavy metals in pharmaceutical and biotherapeutic products. The use of inductively coupled plasma (ICP) instrumentation is considered the ideal method to determine elemental impurities present in drug products and raw materials. This approach has been proven to be accurate, sensitive, linear, and satisfactory to include in filing reports.

Topics: Regulatory Compliance Webinars Elemental Impurities

SCIENTIST SPOTLIGHT: June 2018

Name: Nadezjna Vaes
Alcami Site: Weert, Netherlands

How long have you been with Alcami?
The first of July I will celebrate one year of working with Alcami. After graduating from university, I immediately started working here.

What is your role? 
I am a part of the Quality Control Group, primarily focusing on ICP-MS analysis, in process controls and stability studies.

What is the most rewarding part of your job?
The most rewarding part of my job is feeling that my work makes a positive difference in other people’s lives. This job offers me the opportunity to learn at the cutting edge of current knowledge and to contribute to new discoveries.

Topics: Alcami Voices

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 Presenting and Exhibiting at Biotech Outsourcing Strategies 2018

Alcami will be presenting and exhibiting at Biotech Outsourcing Strategies to be held 19-20 June 2018 in Basel, Switzerland. Be sure to stop by Booth #26 and connect with our team.

We will also be presenting: Accelerating Drug Development by Automation.

Topics: Events

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: Company News Alcami in Action

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: Company News Analytical Testing Development Analytical Development Drug Product

Alcami Presenting and Exhibiting at 7th Annual HPAPI Summit

Alcami will be presenting and exhibiting at the 7th Annual HPAPI Summit to be held June 19-21, 2018 in Boston, MA. Be sure to connect with the Alcami team!

We will also be presenting: Containment, Convenience and Chemistry: Balancing HPAPI Control With the Chemistry and Efficiency Needs of a CDMO

Topics: Events

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: Resource Center Regulatory Compliance Serialization Drug Product

Alcami Presenting and Exhibiting at Chemspec Europe 2018

Alcami will be presenting and exhibiting at Chemspec Europe 2018 to be held 20-21 June 2018 in Cologne, Germany. Be sure to connect with us at Stand C144. 

We will also be taking part in the Pharma Lecture Theatre 2018 with a presentation, as well as participation in a panel discussion.

 

Topics: Events