Dosage Forms

A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.

The author presents best practices for extractables and leachables.

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.

A conversation with Kevin Brady of Alkermes about how high potency APIs are changing the way drugs are developed and manufactured in terms of process, equipment and regulations, including a case study that demonstrates the effective scale up or manufacture of a drug with a highly potent API.

A screening method predicts delamination in primary packaging.

Semi-automatic technology aids egg-based influenza vaccine production in smaller facility footprints.

PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production.

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

The lipid-based method provides a tool for delivery of highly potent, poorly soluble, and unstable APIs. And new in-process capsule printing and shell technologies expand softgels’ applications further.

Conjugated vaccines are meeting the need for longer-lasting immune responses, but the production process is complex, and manufacturers are looking for simpler solutions.

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

The Fluid Air Tablet Coating System consists of a modular air atomizing manifold, liquid-delivery skid, and Batch Architect process controls.

Models and modeling software gain a foothold in solid-dosage manufacturing process design.

Crushing, fracturing, and bending tests quantify hardness.

The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.

GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.

The South Wales, UK contained-manufacturing operation was built in less than a year using design-to-manufacture and modular approaches.

Adoption of single-use systems and more flexible systems drive innovation.

Greater automation and the adoption of solid versus perforated pans are some recent advances.

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.

Crushing, fracturing, and bending tests quantify hardness.

Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market.

Drug manufacturers today are increasingly challenged to find new, effective methods for the delivery of active pharmaceutical ingredients, and many are discovering that orally disintegrating technologies can help.