Dosage Forms

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.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Patheon, shared his perspective of changes to solid-dosage pharmaceutical manufacturing.

Tablet coating from DISONA can handle batch sizes up to 3 kg.

The BIOSTAT STR single-use bioreactor family from Sartorius Stedim Biotech is based on a conventional stirred-tank design.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.

Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.

New ADC therapies must overcome manufacturing challenges to reach market.

As commercial manufacturing considers single-use materials, a look shows how industry moved to the technology.

The more pharma science and technology change, the more business and policy concerns stay the same.

Polymers and surfactants impact stability and long-term performance.

FDA is working with manufacturers to encourage industry innovation.