Dosage Forms

Eric Jayjock, Patheon’s director of continuous manufacturing, discusses the CDMO’s plans for its new continuous manufacturing business.

Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

The advantages of single-use systems become clear as they become more broadly implemented.

ChargePoint Technology is expanding its US presence by opening a new office in San Francisco.

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

Gerresheimer’s glass and plastic prefillable syringes will come with an innovative, integrated, passive syringe safety solution, acquired through an exclusive licence from West Pharmaceutical Services.

The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.

GE Healthcare’s Dharmacon business and CordenPharma contract manufacturing enter a strategic collaboration to accelerate the oligonucleotide development process.

Recro Gainsville expands its tableting capacity with the addition of a tablet press and film coater.

Lilly will provide up to $52 million in funding for research, making this Purdue’s largest strategic corporate collaboration

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The Spanish CDMO has installed a new automatic capsule filling machine at its EU GMP-approved plant in Pamplona, Spain

Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.

Oral solid-dosage and parenteral drug manufacturing equipment and systems have made great strides in safety and efficiency.