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Alcami Announces Sale of its Weert, Netherlands Facility

Next Step in Alcami’s Strategic Plan to Focus its Platform on High-Growth Market Segments

Durham, NC (USA) – January 8, 2020 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the sale of its preclinical and early stage active pharmaceutical ingredient (API) facility in Weert, Netherlands to MercachemSyncom, a leading mid-sized European integrated drug-discovery and development contract research organization. Terms were not disclosed. 

Topics: Company News API Contract Manufacturing Services Contract Development Services

Video: High-Potency APIs

The increasing trend of using highly potent active pharmaceutical ingredients (HPAPIs) in new drug development candidates has created a tremendous demand for high containment development and production capabilities.

Alcami is a trusted partner for the development and manufacture of HPAPIs. Our Germantown Center of Excellence for API development, scale up, and commercialization provides an exceptional platform for control strategy at each phase of the development process through a series of investments targeted at infrastructure, workforce, tools, and technology. Alcami’s extensive regulatory expertise allows innovators to execute all parts of development and manufacturing in one US‐based location to support the launch of tomorrow’s medicines.

Topics: Company News HPAPI API Videos

Video: Animal Health

Alcami will support your animal health products, both companion and livestock, with precise attention to quality by design and process development. We have experience advancing over 50 animal health products from concept through commercialization, with services ranging from analytical support to manufacturing of active pharmaceutical ingredients (APIs), oral solid dose (OSD) products, and sterile (liquid and lyophilized) products. 

Topics: Company News Analytical Testing Analytical Development API Drug Product Videos Animal Health

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 API Formulations

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

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

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

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