Reduce the risks of your sterile manufacturing program with Alcami

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21/10/2022

| 6 minute read

Sponsored by Alcami

With Mike Babics, Vice President, Parenteral Services, at Alcami

I began my career working in the development and manufacture of retroviral proteins for HIV research shortly after completing my undergraduate degree in biology at Wheaton College. This early experience in CMC sparked interest in the parenteral development space within the life sciences. I then pursued an MBA and after graduate school, Samuel Fleming, the founder of Decision Resources and father of a close friend, recommended the CDMO industry as a way to experience first hand the impressive range of technologies used in life sciences. I never looked back and will always be grateful for Sam’s advice.

It is an incredibly exciting time to work in the biopharmaceutical field and I encourage anyone studying health sciences to consider joining the CDMO industry. I feel privileged every day to work with such talented team members, while helping customers bring breakthrough products to patients around the world.

Alcami is a sterile and solid dosage CDMO based in the United States for over 40 years. I had the pleasure of working at Alcami with the current management team from 2010 to 2015, focusing on expanding Alcami’s presence in the New England region. I joined the company in 2021 as an expert in the manufacture of biological and sterile products within the business development team. We focused on expanding our sterile manufacturing offerings from a single fill-finish line, which already manufactured more than 25 liquid and lyophilized sterile commercial products, to six fill-finish lines, with the addition of five new isolator lines for filling vials. , syringes, cartridges and freeze-dried products.

The continued growth in demand for new therapies, combined with dwindling capacity and material constraints throughout the ramp-up of COVID-19 vaccine manufacturing, has led to an increased need for efficient use of material. generated by batches of GMP drug substances on a smaller scale. . Since 2020, a significant percentage of global industry resources, including facilities, consumables, raw materials and operational personnel, have been channeled into pandemic response or impacted by supply chain and challenges clinics. These issues have caused delays for thousands of clinical programs. These program sponsors and their CDMO partners had to use a multitude of approaches to maximize the effective use of their GMP material at every stage of the process, from formulation, analysis, manufacturing to clinical administration and even at commercial launch.

Another pressing topic for industry is the revised EU GMP Annex 1, which was released with updated requirements for the manufacture of sterile drugs at the end of August 2022. The pharmaceutical industry had one year to comply with the new annex revision, and two years for lyophilization systems. Of particular interest is the regulatory expectation that barrier systems (or isolators) will officially be a default expectation for the aseptic processing of any product intended for administration in countries following EU directives.


Over the past two years, we have invested more than $150 million to ensure we are at the forefront of the industry in implementing best practices across all of our US-based facilities.

It is crucial for a CDMO to develop a comprehensive technology transfer process that allows for early identification and planning to properly prepare and, therefore, mitigate high-risk parts of a client’s process. It is also essential to have the right expertise, technology and facilities. An example of how Alcami helps prevent risks in sterile manufacturing can be found in our investment in our brand new flagship fill-finish facility at our Morrisville, NC campus, just 10 minutes from the Raleigh Airport. The facility was designed using the fundamental principles of quality by design to ensure that it would meet its intended purpose as a parenteral filling facility in all aspects. We considered the physical layout, utilities, air handling and material flow before installing the new isolator technology, and we use single-use systems with flexible filling and minimal line loss.

Indeed, we are committed to continuously investing in our facilities, the training of our staff and our quality systems in order to minimize the risks at each stage of the development of our customers’ products. Over the past two years, we have invested more than $150 million to ensure we are at the forefront of the industry in implementing best practices across all of our US-based facilities. Alcami has invested in benchmark technology standards in all our facilities, including isolators, freeze dryers, formulation technologies, environmental monitoring, analytical equipment and their supporting technologies.

This approach has been at the heart of Alcami’s multi-year expansions across our five US campuses, and it not only ensures the highest quality but also the greatest risk reduction for the programs entrusted to us.

Since 2020, in anticipation of recent Schedule 1 revisions, Alcami has purchased and installed five new insulator filling finishing lines and three state-of-the-art freeze dryers with automated loading and unloading technology. These investments, combined with the recently completed expansions of all our analytical laboratories, will enable Alcami and its customers to meet current and future regulatory requirements, and ensure that we can meet the growing demand for clinical and commercial injectable products distributed in the world market. the United States.

Simply put: reduce risk in a program. Sponsors are looking for CDMO partners who offer in-depth development of formulations and analytical methods that can be easily transferred to non-GMP batches for toxicology material and then eventually into GMP manufacturing and release.

But finding the right CDMO can be tricky. Industry consolidation through mergers and acquisitions has resulted in a smaller group of CDMOs with relevant industry knowledge and a good regulatory track record of successful INDs, PAIs and BLAs.

Is Alcami the right partner? Alcami has been providing expertise in drug development, manufacturing and analysis for over 40 years. During this time we have worked with an incredible range of clients and products. We have comprehensive development and analysis capabilities, strong technical expertise, cutting-edge technology, and a history of working with our client’s CMC, analysis, and program management teams to meet program deadlines. We strive to be the CDMO of choice for the formulation, development and analytical testing, manufacturing, stability and long term storage of clinical and commercial drug products for solid dosage and parenteral products.

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