Research

Process Development for Scaled-up hESC/hiPSC Manufacturing

An optimized 14-day manufacturing workflow which produces > 10^10 , cells was developed in < 12 months

Navigating a changing healthcare landscape with a focus towards patient centricity

When road conditions change, it is important to check your roadmap if you want to successfully reach your destination. Due to a rapidly changing global healthcare landscape, various developments are affecting the way in which companies are navigating…

Assessing the Financial Impact of Translational Pharmaceutics®

Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months & lowers R&D costs by more than $100 million per drug.

MAY THE FLOW BE WITH YOU: CONTINUOUS FLOW MANUFACTURING OF PHARMACEUTICAL INGREDIENTS

While batch process chemistry remains the standard in the pharmaceutical industry, a clear increase in continuous flow processes has emerged over the past decade thanks to the commercialization of preparative flow reactor units. In a recent survey…

Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances and Challenges

Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Many cell therapies have been shown to be efficacious in humans, suc…

Commercial Scale Manufacturing of Allogeneic Cell Therapy

Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Pluripotent stem cell (PSC) derived therapies, in particular, have substantial momentum and the potential to serve as treatments for a wide range of indica…

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.

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Research

November/December 2019

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