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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

Editorial: Designing a CMC Strategy for Accelerated Development of Biotherapeutics

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Designing a CMC Strategy for Accelerated Development of Biotherapeutics."

As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity. There are many drivers to accelerate development.

Topics: Thought Leadership Regulatory Compliance Biologics Editorials CDMO Parenteral Manufacturing Cell and Gene Therapies

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 CDMO API HPAPI Manufacturing

White Paper: Guide to Pharmaceutical Serialization 2017

As required by the Drug Quality and Security Act (DQSA) signed into law by President Obama on November 27, 2013, serialization will be required by pharmaceutical manufacturers on all commercially distributed prescription human drug products effective November 27, 2017. 

This guide is designed to serve as a reference for the core information, issues, and questions pharmaceutical companies must address as they work with their CDMO and other members of their supply chain.

Topics: Resource Center Serialization Supply Chain CDMO

Editorial: Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs." The article includes Alcami, along with other CDMOs, highlighting their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

Topics: Thought Leadership Manufacturing Editorials CDMO Development

Editorial: Alcami Featured in Pharma Horizon's January 2017 Issue

Syed Husain, Alcami CCO is featured in an article published in Pharma Horizon's January 2017 issue. The article, written by Cynthia Challener, Scientific Content Director at That's Nice, LLC discusses next-generation therapies: overcoming bioprocessing, characterization and logistics challenges. 

Topics: Thought Leadership Manufacturing Editorials CDMO

Editorial: Supporting the Pharma Industry Small Business Growth Engine

As published in Pharma's Almanac Q1 2017.


Small and medium-sized companies generate
greater than two-thirds of the clinical candidates
in the pharma and biotech industry drug pipeline.
They often, however, lack the knowledge and
resources required to take a new medicine from
the lab to the market and need support
from CDMOs that offer integrated, tailored,
customized solutions and personalized
technical support.

Topics: Thought Leadership Editorials CDMO