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Editorial: Outsourcing Analytical Testing - The Gateway to Drug Manufacturing

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Outsourcing Analytical Testing: The Gateway to Drug Manufacturing."

Alcami: Customizing Programs to Meet Accelerated Product Timelines

Alcami is a CDMO that offers fully integrated, comprehensive analytical testing to support technologies for every stage of development. Its laboratory services platform is comprised of analytical testing and development services for small molecule and biologics drug products, as well as specialized offerings such as elemental impurities, abuse deterrence, and extractables and leachables. In addition, formulations development scientists address challenges related to new chemical entities.

Topics: Thought Leadership Editorials Analytical Testing

Editorial: A Practical Approach to Extractables & Leachables

Alcami recently authored an article featured in Drug Development & Delivery titled "A Practical Approach to Extractables & Leachables." 

INTRODUCTION

The study of extractables and leachables (E&L) has been evolving for many years. As pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it. Many of the case studies that initiated interest in extractables and leachables are based on primary packaging. In some cases, the secondary or tertiary packaging were identified as sources of leachables. As a result, the primary emphasis of extractables screens has been on the packaging systems. The approach to these screens is well established. The first iterations of regulatory guidance addressed the common packaging materials in the United States Pharmacopeia (USP) chapter <661>, which relied heavily on physiochemical testing to characterize the material of construction but did not directly address extractables testing of the final packaging materials in detail. With advancements in the manufacture of plastics and increasing variety of base polymers used for packaging systems, it became evident that more specific guidelines are needed.

Topics: Thought Leadership Editorials Extractables & Leachables

Editorial: Aligning with Sponsors for Strategic Growth

As published in Pharma's Almanac Q3 2018.

In the current climate, the success of innovative small and medium-sized drug companies is increasingly important to the success of the industry as a whole. Alcami is focused on enabling the growth of these firms and, in the process, changing the structure of the market. Having demonstrated the feasibility of our integrated business model and educational strategy, we are taking these efforts to the next level through our partnership with Madison Dearborn Partners (MDP).

Topics: Thought Leadership Editorials

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: Editorials Biologics

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

Editorial: Pharma CEO Talks Company Growth, Jobs with New Triangle HQ

Dr. Stephan Kutzer, CEO, President and Chairman of Alcami Corporation, sits down with the Triangle Business Journal to discuss company growth, jobs with new Triangle HQ.

For contract development and manufacturing organization Alcami, moving a planned headquarters expansion from Wilmington to the Triangle was just the beginning of continued investment in North Carolina, other U.S. bases and abroad, says President, Chairman and CEO Stephan Kutzer.

While Alcami's headquarters expansion was originally planned for Wilmington as the company's previous base and from a "sheer size" perspective, it decided last year to move its headquarters to the Triangle for reasons including recruitment and growth in highly technical areas and presence in a hub of the pharmaceutical industry crucial to attracting investors and customers, according to Kutzer. 

Topics: Company News Editorials

Panel Discussion: Oral Solid Dosage Manufacturing Process 

Alcami recently contributed to Pharma Horizon's first Panel Discussion of 2018, dedicated to the Oral Solid Dosage (OSD) Manufacturing Process. 

The topics discussed include main challenges that manufactures of OSD forms have to face, such as quality, safety and productivity, as well as technical advancements, production management, operational excellence aspects, tech transfer, and packaging operations.

Topics: Thought Leadership Editorials Manufacturing Oral Solid Dose

Editorial: Driving Change in the Pharma Industry and Biotech One Relationship at a Time

As published in Pharma's Almanac Q1 2018.

Although small and medium-sized pharma and biotech companies are driving the growth of the industry, they often don’t receive the attention and assistance that are essential to their success. Changing the industry’s mindset is critical. Alcami is establishing many different relationships intended to facilitate and accelerate just that.

Topics: Thought Leadership Editorials

Editorial: Is industry ready for the serialisation shake-up?

Alcami recently authored an article featured in Chemistry World titled "Is industry ready for the serialisation shake-up?"

The regulation few outside of pharma have heard about

Within the next year, pharmaceutical industries in the US and EU will undergo what could be considered one of the greatest regulatory shake-ups in the modern era. Government regulation – coming into force in late 2018 and early 2019 for the US and EU respectively – dictates that all pharmaceuticals be subject to track-and-trace capabilities, also known as serialisation.

Topics: Thought Leadership Editorials Serialization

Editorial: Transparent and Timely Testing

Alcami recently authored an article featured in Speciality Chemicals Magazine titled "Transparent and Timely Testing." 

Analytical testing is a pre-requisite for the majority of products that use specialty chemicals, but it can be time-consuming and complex. CDMO Alcami outlines the advantages of using a CDMO and introduces its Alcami OnDemand program management portal, which offers transparency and quick turnaround times.

Topics: Thought Leadership Editorials Analytical Testing Alcami OnDemand