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Editorial: HPAPIs - A CDMO View

Alcami recently contributed to an article in Specialty Chemicals Magazine titled "HPAPI's: A CDMO View."

Alcami has gained extensive knowledge on HPAPI manufacturing from building new suites at its US API development and manufacturing site

Over the course of 2016-2017, global CDMO Alcami built and qualified a new facility for highly potent compounds at its facility in Germantown, Wisconsin. During the design phase, says Adam Kujath, global senior director of manufacturing science & technology, the company put considerable thought into what was needed to match its existing capabilities – it has a very diverse customer base and works with many different molecules – to market needs.

Take a Virtual Tour of Our HPAPI Suites

Topics: Thought Leadership HPAPI Editorials HPAPI Manufacturing

Editorial: Fuelling Pharma's Innovation Engines

Alcami President & Chief Executive Officer Dr. Stephan Kutzer recently took part in an interview for Manufacturing Chemist titled "Fuelling Pharma's Innovation Engines." 

According to Stephan, small and mid-size pharma and biologics companies are the innovation engines of the industry. “Each year, the number of new INDs and NDAs increases and we anticipate this trajectory to continue. We see more than 5000 clinical introductions on an annual basis. Cancer treatments are a particular area of focus for many of our clients and we expect our pipeline for these therapies to grow within the next 5 years. Our target accessible market is around $8 billion.”

KR: How does Alcami plan to grow with the industry?

SK: We have strategically invested in capability extensions and operational excellence initiatives to better meet industry demand. At our Germantown (Wisconsin, USA) Center of Excellence for API development, scale-up and commercialisation, we have supplemented our existing pipeline with HPAPI suites and controlled substance capabilities.

Topics: Company News Thought Leadership Editorials

Beyond the Bench: UNC Wilmington Classroom to cGMP Laboratories

Alcami and the University of North Carolina Wilmington (UNCW) have partnered on an academic program that connects education and work experiences for students pursuing scientific careers, especially in pharmaceutical sciences. This edition of the Beyond the Bench series will highlight the laboratory-based course taught at UNCW’s state-of-the-art marine biotechnology center (MARBIONC), “Current Good Pharmaceutical Quality Control Laboratory Practice,” focused on the application of Current Good Manufacturing Practices (cGMPs) in a drug development and testing laboratory.

In 2016, leaders from Alcami and UNCW met to discuss potential opportunities to work together on biopharmaceutical projects. Many of Alcami’s Wilmington employees are UNCW graduates, and Alcami has a long history working with the university on employee education programs and pharmaceutical projects. Steve Fontana, JD, from UNCW’s Office of Intellectual Property and Commercialization; UNCW Chancellor Dr. Jose V. Sartarelli, and Alcami President and Chief Executive Officer (CEO) Dr. Stephan Kutzer initiated conversations that resulted in the development of the present partnership.

Topics: Thought Leadership Alcami in Action Alcami Voices

Staying Ahead of OSD Challenges

Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges must be immediately addressed to keep timelines on track. In early-stage OSD formulation development, complex solubility issues, difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API) all can lead to delays in development. During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physicochemical characteristics of a product.

Topics: Thought Leadership Serialization Oral Solid Dose Packaging Pharmaceutical Packaging

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 Extractables & Leachables Editorials

PART II: HPAPI Market Forecasts and Manufacturing Challenges

In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and the main manufacturing challenges involving highly potent APIs.

Read Part I: HPAPI Market Forecasts and Manufacturing Challenges

As demand for contract development and manufacturing of HPAPIs continues to increase from both new and existing relationships, it is important to anticipate and proactively expand to meet those needs. At Alcami, current market trends and our small molecule expertise drive our strategy to continue to invest in new capacity and expand our capabilities within this submarket.

Topics: Thought Leadership HPAPI API HPAPI Manufacturing

PART I: HPAPI Market Forecasts and Manufacturing Challenges

In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and the main manufacturing challenges involving highly potent APIs.

The highly potent active pharmaceutical ingredient (HPAPI) market is one of the fastest growing CDMO submarkets, approaching a 9 percent compounded annual growth rate (CAGR). There is a continued industry focus on pipeline development oncology drugs, which by nature of indication is producing compounds that are increasingly potent.

Topics: Thought Leadership HPAPI API HPAPI Manufacturing

Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances

Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.

Topics: Thought Leadership Regulatory Compliance API Drug Product Controlled Substances

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