Dosage Forms

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.

Biotech-based therapies and a move to single-use processes highlight recent industry changes.

ISPE measures impact of biotechnology and globalization on personalized medicine.

Advancements in cell culture and protein technology have opened the door for new therapies.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

The agency announced a plan to eliminate its existing orphan designation request backlog.

The directorate highlights its 2016 achievements.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

BIO report measures decade-long investment and acquisition trends for emerging biotech companies.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

Takeda inaugurated expanded capacity of solid-dosage drugs at its site in Oranienburg, Germany.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.