Have a Highly Potent API? Here's What You Need to Consider

Given the risks highly potent active pharmaceutical ingredients (HPAPIs) present in cross-contamination and containment, it is important to consider manufacturing and handling approaches carefully. In fact, because of the demands of HPAPI manufacturing, many drug developers select a contract development and manufacturing organization (CDMO) partner to make the substance. The discussion below outlines some of the considerations for HPAPI manufacturing and, when appropriate, HPAPI CDMO selection.

HPAPI Manufacturing
With the significant infrastructure and capital investments required for effective HPAPI manufacturing, it is simply not feasible for many of the small and mid-size companies to make this extensive investment. In the suites alone, Alcami is investing approximately $7 million in 2017. Not to mention its investment in skilled personnel and procedural development. These levels of investment are not possible or prudent for many companies.

Topics: HPAPI Blogs


Name: Chris Witzigmann, PhD
Alcami Site: Germantown, WI

How long have you been with Alcami?

I joined Alcami in August of 2016.

What is your role? 
I am a Scientist in Chemical Research & Development at Alcami's Germantown, WI site.

What is the most rewarding part of your job?
Solving complex problems and translating the solutions from small scale work in R&D to the manufacturing scale.  Knowing that our work improves the efficiency and, most importantly, the quality of the APIs that we produce is very rewarding.

Topics: Blogs

Editorial: Fighting Prescription Drug Abuse with Demonstrated Abuse-Deterrent Formulations

As published in Pharma's Almanac Q3 2017.

As the number of opioid prescriptions in the US has climbed dramatically, so has the abuse and misuse of these drugs, leading to loss of life and significant social costs. The pharmaceutical industry, in conjunction with FDA, has focused on identifying approaches for the development of abuse-deterrent opioid formulations and methods for demonstrating their effectiveness. Choosing the right strategy for a given drug can be difficult. Partnering with a contract development and manufacturing organization (CDMO) that has experience with different abuse-deterrent opioid formulation methods and established expertise in the development of in vitro abuse-deterrent studies can accelerate approval.

Topics: Abuse-Deterrence Editorials

White Paper: 4 Factors Critical to the Financial Success of an Emerging Pharmaceutical Company

Alcami has recently authored a white paper discussing 4 factors that are critical to the financial success of an emerging pharmaceutical company.

This paper will address company structure decision making, funding approaches, perfecting the investor pitch and hitting key milestones – the exciting and challenging journey of a growing pharmaceutical company.

Topics: White Paper / eBook

Minimize Supply Disruption at Any Life Cycle Phase

As supply chain complexities grow, risks can arise at every phase of the product lifecycle. From quality issues and drug shortages to new serialization regulations and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Alcami has been thinking extensively about what we can do to help solve this challenge.  As a result, we have created, Protect Your Brand®, a unique offering designed to support pharma and biotech companies pursuing a dual source strategy.

Under this program, Alcami will support tech transfer and validation of products in advance of potential manufacturing needs without any long-term commitment or minimum annual volume. We have developed a process to systematically analyze and identify supply risks and to create a backup plan accordingly. We use our proprietary State of Alcami Readiness™ scoring system to assess and assign a risk level to the supply chain in question.

Topics: Supply Chain Blogs

Stability: Back to the Basics - Part I

Part I: The Importance of Stability in the Evaluation of Quality Attributes of Pharmaceutical Drug Products

In this five-part blog series, Alcami subject matter experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals, beginning with quality attributes.

Exactly how important is stability testing in the life of the active pharmaceutical ingredient (API) or drug product?

The quality attributes that everyone strives for are safety, product efficacy and integrity, appropriate storage conditions, and shelf life.

Topics: Stability Blogs

At-A-Glance: Highly Potent API

The highly potent active pharmaceutical ingredient (HPAPI) market is growing rapidly with no signs of slowing down. But what is it, how is the market changing, and what are the expected trends in this space?

What Is HPAPI? 

HPAPI is generally defined as:

  • A pharmacologically active biological ingredient or intermediate with activity at approximately 150 µg/kg of body weight or below in humans (therapeutic daily dose at or below 10 mg)
  • An API or intermediate with an occupational exposure limit (OEL) at or below 1µg/m3 of air as an 8-h time-weighted average
  • A pharmacologically active ingredient or intermediate with high selectivity (i.e., ability to bind to specific receptors or inhibit specific enzymes) and/or with the potential to cause cancer, mutations, developmental effects, or reproductive toxicity at low doses
  • A novel compound of unknown potency and toxicity
Topics: HPAPI Blogs

Alcami Announces Grand Opening of St. Louis, Missouri Facility in Cortex Innovation Community

Durham, NC – September 12, 2017Alcami Corporation, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announced the unveiling of its new analytical testing facility, located at 4260 Forest Park Avenue, in the Cortex Innovation Community, a 200-acre innovation hub and technology district located in St. Louis’s historic Central West End neighborhood. Alcami will welcome the public with a grand opening ceremony September 13, 2017, sharing the company’s outlook and key capabilities with clients and community leaders. The state-of-the-art facility will be Alcami’s new Center of Excellence for its advanced analytical testing operations.

Topics: News & Events

How Risk Assessment and Planning Safeguard a Supply Chain

The risks within the pharmaceutical supply chain are many and varied. However, the risk level of a given supply chain can be assessed, and risk reduction and strategic readiness plans can be created. While it is impossible to mention all the possible supply chain risks within one article, the following two scenarios are very common.

Scenario #1
A small pharmaceutical company in the middle of late-stage clinical trials ran into a huge problem when it was uncertain whether or not their contract development and manufacturing organization (CDMO) could meet their resupply timelines due to capacity restrictions. The substantial market approval delay, which could result from a clinical trial delay, would threaten their funding and jeopardize patient access to this new medication.

Topics: Supply Chain Blogs

Alcami to Establish Active Pharmaceutical Ingredient Center of Excellence in Germantown, Wisconsin

Germantown, WI (USA) – September 6, 2017 – Alcami Corporation, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces the formation of a Center of Excellence at its world-class active pharmaceutical ingredient (API) development and manufacturing facility in Germantown, Wisconsin.

Topics: News & Events

Identifying and Reducing Risks within the Pharmaceutical Supply Chain

For many years, pharmaceutical manufacturers have focused on increasingly stringent supplier certification requirements and other measures of this nature in attempts to reduce risk within their supply chains. Only in recent years have manufacturers recognized that they alone must own and manage the risks associated with their products in a manner that ensures the utmost protection for patients, maintains the integrity of their supplies, minimizes drug shortages, and achieves product development milestones.

Regulatory and quality violations within the supply chain, clinical holds, and capacity challenges represent the most significant risks to supply integrity that pharmaceutical manufacturers must manage.

Topics: Supply Chain Blogs