Dosage Forms

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Study provides first substantive reference data on key quality attributes of empty capsules

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

American Health Packaging announced a voluntary nationwide recall of ibuprofen and oxcarbazepine tablets due to mislabeling on the inner unit dose blister packaging.

New International Council on Biotechnology Associations advocates biotechnology growth.

Fette's FE75 Tablet Press is designed for large batches.

Kraemer KD60 equipment conveys and dedusts vitamin and nutraceutical tablets.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

Jones Packaging introduces a new solid dose vial line in its Toronto facility.

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Funding boosts life-sciences manufacturing in West Michigan.

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

GSK reports 5-year vaccine price freeze for countries graduating from GAVI Alliance.

Progress in equipment availability, process analytical technology, and advanced process control aids ongoing development of continuous solid-dosage manufacturing processes.

New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

Application of single-use technology in a parenteral facility for syringe filling.

An interview with Doug Hausner, C-SOPS, about continuous manufacturing

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

The Manesty TPR 500 tablet press from Bosch Packaging Technology increases output and features a hygienic design.

New formulations and expanded vaccine production are encouraged.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.