Formulation and Drug Delivery

Biosimilars: Making the Switch Comes with Challenges

June 01, 2016

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

FDA Releases Guidance on Topical Patches

May 31, 2016

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Removing Troublesome Solubilizing Excipients from Injectables

May 19, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Althea Patents Method to Crystallize Proteins

May 18, 2016

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

Capsugel Expands Micro-Dosing Services

May 16, 2016

Combining powder micro-dosing services with the Xcelodose technology, Capsugel offers capabilities in both North America and Europe.

Lessons Learned Accelerate Vaccine Development

May 15, 2016

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Biosimilars Council Says New Reimbursement Rules Will Hurt Competition in the Biosimilars Market

May 10, 2016

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

Investigational Malaria Vaccine May Protect Healthy Adults for More Than One Year

May 10, 2016

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

PTSM: Pharmaceutical Technology Sourcing and Management

ADCs Challenge Manufacturers’ Skill Sets

May 04, 2016

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

MilliporeSigma Expands California GMP Facility

May 04, 2016

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.