Dosage Forms

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.

Roger Hayes of MPI Research discusses highly potent drug development.

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.

ProBioGen signs agreement with Emergent BioSolutions for access to ProBioGen's avian AGE1.CR cell line.

Leidos Holdings awards Pfenex a subcontract in support of the development of an anthrax vaccine.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

Pfizer appoints management changes to take effect in 2014.

Operator training, preventive maintenance, and regularly scheduled calibration help prevent the manufacture of off-weight tablets.

Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

Excipients for lowering formulation costs and improving lipid-based formulations and the use of melt-spray-congeal microsphere sachet technology for targeted controlled release attract attention at the 2013 American Association of Pharmaceutical Scientists Annual Meeting.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Tablet Tooling Coating Reduces Formulation Sticking

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

In this sponsored podcast, Adam Stuart, Senior Design Engineer at 3M Drug Delivery Systems, discusses the role of dose counters for metered dose inhalers and the technical challenges companies can face when adding this feature to their inhaler products.

Stada licenses 3M's transdermal technology for a fentanyl patch.

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

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

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds.

Intertek is now offering comprehensive services for the development of orally inhaled and intranasal drug products (OINDPs) for both small molecules and biologics.

Screening methods and predictive models address tenacious tablet-sticking problems.

Progress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges

Generic Drug Super Office Takes Shape

Bend Research adds powder-filling technology.

The benefits of solvent-free processes and techniques specifically optimized for coating new dosage forms such as orally disintegrating granules are reviewed.

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