Manufacturing, Biologic Drugs

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

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

HHS plan makes progress in ensuring availability of safe vaccines.

EMA releases an update on its flu vaccine guidance.

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

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

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

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 management changes to take effect in 2014.

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

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in the United States to prevent this deadly disease, when such a therapy is approved in Europe and Australia.

John J. Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America of the PhRMA Research & Hope awards and creating an ecosystem for promoting new vaccine development

Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.

GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.

Roche's plans for a major biologics manufacturing expansion is the latest investment by Big Pharma

Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.

Scientific Digital Imaging's Synbiosis Division introduces SynStats statistical analysis software.

Advanced Biosciences Laboratories will support the development and production of a novel Shigella vaccine candidate for PATH.

USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.

Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.

The Biomanufacturing Research Program (BioMAN) at Massachusetts Institute of Technology (MIT) has received $10.4 Million from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics.

Merck & Co gets FDA approval to manufacture bulk varicella at its in Durham, North Carolina for use in chickenpox and shingles vaccines.

Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.

Avacta?s Optim 2 instrument provides a practical solution for determining the conformational stability of adjuvant bound vaccines, eliminating the need for awkward and time consuming standard analytical techniques. [more?..]

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

Novartis and Biological E, a biopharmaceutical company based in India, have entered into an agreement that aims to deliver affordable and accessible vaccines for typhoid and paratyphoid A fevers to developing countries and thereby address the unmet medical need in endemic regions.

Conjugated vaccines are meeting the need for longer-lasting immune responses, but the production process is complex, and manufacturers are looking for simpler solutions.