Manufacturing, Biologic Drugs

Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate

March 26, 2014

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

FDA Releases Guidance on Vial Fill Size

March 13, 2014

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

FDA Details National Vaccine Plan

March 11, 2014

HHS plan makes progress in ensuring availability of safe vaccines.

European Medicines Agency Updates Seasonal Flu Vaccine Guidance

February 11, 2014

EMA releases an update on its flu vaccine guidance.

MedImmune Signs Cancer Pact with Immunocore

January 09, 2014

MedImmune has entered into a research collaboration with Immunocore to develop novel cancer therapies.

The Role of NMR and Mass Spectroscopy in Glycan Analysis

January 02, 2014

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody Fragments

January 02, 2014

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Early Communication with Regulators is Essential for SMEs

January 02, 2014

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

Pfizer Appoints Head of Vaccines

December 19, 2013

Pfizer appoints management changes to take effect in 2014.

EMA Launches Vaccine Monitoring Project

November 26, 2013

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.