Research

Ophthalmic Drug Delivery for Retinal Disorders

This whitepaper explores the development and manufacturing considerations associated with ophthalmic drug delivery, with a focus on retinal disorders.

Current Trends and Emerging Needs for Microbial Fermentation

Over the last decade, the potential of fermentation-based manufacturing has expanded dramatically due to advances in synthetic biology and genetic engineering.

5 ADC Manufacturing Challenges You Need To Know

Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.

Simplifying Recombinant Protein Production: Breaking Down the Corynex Protein Expression System

The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses.

Critical Factors of Fill Finish Manufacturing For Biologics

The bulk drug substance, formulation, and sterile filtering and filling of the final drug product all require special handling procedures.

Is Your Complex Formulation Process Set Up for Success?

Often, the implementation of specialized equipment and/or processes is necessary to ensure successful formulation.

Preparing for Your CDMO Selection Process

Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing.

Cost-Effective Solution to Filing Your CMC Supplement

Opioid Reformulation for Abuse Deterrence — Filed as a CMC Supplement in Less Than a Year

Hot Melt Extrusion for Oral Solid Dosage Forms

HME is an efficient and trusted tool that improves solubility and enables the development of oral solid dosage forms from BCS Class II and IV compounds.

Leak Rate Testing for Freeze Dryers: A Scientific Approach

Assurance of the vacuum integrity of freeze - dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations; however, there is currently no generally accepted scientific rationale for establishing acceptance crite…

Pharmaceutical Development for ADCs: Not as Simple as ABC

Formulation, process, and analytical development for antibody - drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path a…

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Research

November/December 2019

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