Dosage Forms

HHS plan makes progress in ensuring availability of safe vaccines.

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

Capsule filler

Speedy Filler Produces 200,000 capsules/hr

Tablet Press

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

Tablet Press with Fastest-in-Class Changeover

Discovery of split and broken tablets led to drug recalls.

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

EMA releases an update on its flu vaccine guidance.

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

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.