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Editorial: Enabling Technologies Advance Poorly Soluble Highly Potent APIs

Alcami recently contributed to a special feature in Pharmaceutical Technology magazine, titled "Enabling Technologies Advance Poorly Soluble Highly Potent APIs."

Excerpt from Alcami: In fact, challenges in containment can limit the technology that can be deployed for solubility enhancement, according to Adam Kujath, global senior director of manufacturing science and technology at Alcami. “Typical API approaches for solid dosage forms to improve solubility like micronization and spray drying are more difficult to outfit with appropriate containment systems. For instance, milling of solids, while not impossible to do in appropriate containment, poses a challenge since it tends to create dust in the breathing airspace for any worker. For parenteral formulations, lyophilization presents a similar challenge,” he says.

Topics: Thought Leadership HPAPI Editorials CDMO API Formulations API Containment HPAPI Manufacturing

Crystallization in Solid State Chemistry

Solid state chemistry plays a major role in successfully developing a compound into a drug product. The physical and mechanical properties are important in selecting the most appropriate stable form with sufficient solubility. The occurrence of crystallization from a crude reaction mixture is the first step towards obtaining a pure drug substance.

For process chemists crystallization is an essential tool for isolation and purification of the compound in a robust and reproducible way. In addition, the crystallization conditions impact the crystal form or polymorph, particle habit, and its characteristics like stability and bio-availability. Optimized pharmaceutically-acceptable crystallization conditions are established by varying cooling profile and slurry conditions, by adding anti-solvent, or by applying seeding to obtain the preferred form, if needed.

Topics: Solid State API Crystallization

The 6 Pillars of Solid State Chemistry

Solid state chemistry is the study of the synthesis, crystal structure, and properties of solid phase materials. This area of inquiry and analysis is particularly relevant to explore the properties of oral solid dosage formulations.

In the graph provided below, the six pillars of solid state chemistry are illustrated with subcategories included to give further understanding of what solid state chemistry encompasses. Alcami fields this combined experimental and analytical capability through its own Center of Excellence (CoE) for solid state chemistry and crystallization, which is located in its active pharmaceutical ingredient (API) development facility in Weert, Netherlands.

Topics: Solid State API

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

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: Thought Leadership Resource Center HPAPI API HPAPI Manufacturing

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 HPAPI API

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