CapsCanada

Interchangeability Between Hard Gelatin and Hard Hypromellose Capsules Without Gelling Agent

PurposeHard gelatin capsules have long been used in a substantial proportion of oral dosage forms. However, they have some shortcomings. Concerns include the potential to become cross-linked, resulting in problems…
Altasciences

Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing

Liquid-filled capsules offer significant benefits for active pharmaceutical ingredients (APIs) presenting formulation or manufacturing challenges. Their use is beneficial throughout the different phases of drug development, from preclinical to commercialization.…

Monoclonal Antibody Manufacturing for BioPharma: To Build or Outsource?

As the global biologics market continues to grow, securing speed with scale has never been a greater priority. Here we demonstrate important factors to consider in making optimal outsourcing decisions…

Setting The Right Goals: Go Digital, Not Paperless

Digital transformation initiatives can often times result in false starts and inefficiencies by overemphasizing “paperless” environments. Such endeavors focus on identifying and converting paper-based forms and procedures to electronic means,…

N-nitrosamines in Drug Products: Overview, Challenges and Lessons Learned from an API Manufacturer’s Perspective

By Karina Boszko, Head of API Regulatory Affairs and Customer Technical Support Department, Polpharma API Nitrosamines—how has it all started?In July 2018, the pharmaceutical industry was surprised by the unexpected…

Planning for Success, Addressing Quality Early for Gene Therapies

The approvals of Roche’s Luxturna® (2017) for inherited retinal disease and Novartis’ Zolgensma® (2019) for spinal muscular atrophy are indicative of a resurgence in the gene therapy field after a…

Exploring Ultra-Low Temperature Packaging Solutions for Gene Therapies

With the industry moving to more personalized medicine and delivering genetic material to patients to treat conditions resulting from genetic mutations, we speak to Sean Canavan, Operations Manager at Almac’s…

Managing Manufacturing in Times of Uncertainty

Virtual pharmaceutical companies often have strong regulatory and clinical teams, but lack the resources needed to address the complexities of the complete product development and commercialization cycle. Partnering with a…