Formulation and Drug Delivery, Parenterals

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.

The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.

This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

The FlexPro 50, from Groninger, is a modular filling and closing system designed to process vials, cartridges, and syringes, as well as vials in bulk and trays.

Selecting a delivery method early on may be beneficial.

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

Merck KGaA fill-finish expansion in Italy will be completed in 2017.

The authors review the angiopoietin pathway as an alternative for safer and more efficacious anti-angiogenic therapeutics.

A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

A survey provides insight into drug companies' plans for spending on outsourced services. This article contains bonus online material.

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

How to maintain product stability and prevent particulates.

In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

Set limits to provide incentives for process improvements.