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 API HPAPI Manufacturing HPAPI

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 Drug Product Controlled Substances API

White Paper: Optimizing HPAPI Manufacturing Performance

Outsourcing highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing is reaching an all-time high thanks to an increased demand of highly-targeted new drugs with greater efficacy at lower doses and the price of investment to handle internally. Several factors will dictate the performance of a contract development and manufacturing organization (CDMO) when handling HPAPIs. It is not merely a question of having the physical assets for high containment; outsourcing of a specialized and potentially challenging piece of the supply chain requires partnership and collaboration between the CDMO and sponsor. Any relationship is reliant upon transparency, team cohesion, and a level of experience that ensures a collaborative understanding with effective communication. Ultimately, success relies upon the equipment, experience, and a right-first-time ethos. Consider the factors discussed in this white paper when evaluating a potential CDMO partner.

Topics: Resource Center API HPAPI Manufacturing HPAPI Thought Leadership

ON-DEMAND WEBINAR: Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO

Effective high containment API manufacturing has certain expectations and requirements; similarly, being a successful contract development and manufacturing organization (CDMO) has its own distinct challenges. When the demands of these two worlds meet, the ability to balance both offers a unique challenge.

Topics: Webinars API HPAPI

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

Case Study: Orphan Drug Product

According to the Food and Drug Administration and the Orphan Drug Designation program,  orphan status is applicable to drugs and biologics which are defined as “those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.” Due to the high costs and low demands of the drug product, it is important to efficiently use your API supply during the formulation process. This case study presents how Alcami successfully helped a client overcome an API supply shortage using Quality by Design studies to successfully formulate an orphan drug product. 

Topics: Drug Product Oral Solid Dose API Formulations Resource Center Thought Leadership Orphan Drugs

ON-DEMAND WEBINAR: Approach to HPAPI Suite Design in a Multi-Use Facility

Join Alcami for a webinar to learn more about the design approach to highly potent active pharmaceutical ingredient (HPAPI) suite design in a multi-use facility.

As new drug targets naturally become more potent in the search for more effective therapeutics, there is a growing demand for capacity and capabilities in support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.

Topics: Webinars HPAPI Manufacturing HPAPI CDMO API