Dosage Forms

PDA works with FDA to create pharmaceutical quality metrics.

CMOs may find opportunities in alternative expression services.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.

PharmaCell enters an agreement purchase TiGenix therapy production facility.

I Holland announces service that predicts solutions for tablet sticking problems.

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

Novozymes Biopharma has released new study data on extending the serum half-life of albumin in vivo.

Products enable testing in accordance with methods described in new USP monograph.

A study led by Stanford University explains why men may have weaker responses to vaccines than women.

A monkey-vaccine study provides insight into HIV research.

ALpHA G Capsule Filter for Single-Use Systems

Training, calibration, and preventive maintenance help prevent over-and under-weight tablets. The author discusses causes of off-weight tablets and best practices for tableting.

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).