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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

Regulatory Requirements for Early Phase Drug Product Development

Supporting a compound from discovery to clinical phases and potentially commercial phases requires an immense amount of time, energy, and money. Regulatory management is paramount during the drug development pipeline funnel, and recognizing Current Good Manufacturing Practices (CGMPs) is the foundation of drug safety and efficacy.

Every country has its own regulatory authority, responsible for enforcing rules and regulations and issuing guidelines for drug development, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products.[1]

Topics: Thought Leadership Regulatory Compliance Drug Product Preclinical Studies

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

Editorial: Novel Therapies Roundtable Discussion

Alcami recently contributed to a roundtable discussion in Pharma's Almanac magazine, answering the question:

"What truly novel therapies in the earliest stages of discovery and development do you believe will have a significant impact in the future?" 

The article shares insights to this question from Alcami, along with other companies in the biologics space.

Topics: Thought Leadership Biologics Editorials Development