Dosage Forms

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

3M and Impel will collaborate to develop and commercialize Impel’s Precision Olfactory Delivery technology for enhanced central nervous system drug delivery.

Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.

The development of successful ADCs involves careful selection of drug, antibody, and linker, as well as choosing the right attachment chemistry to link the cytotoxic to the antibody.

GEA’s Pony NS2006L is a self-contained, high-pressure laboratory and pilot plant homogenizer for product development of advanced fluid applications.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

The agency releases guidance on controlled correspondences related to generic-drug development.

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

Manufacturers challenge details in new policies designed to promote access to important therapies.

The Krämer KCP10 upward-conveying capsule polisher elevates, polishes, and dedusts capsules.

Lannett Company agreed to purchase Kremers Urban Pharmaceuticals, the US specialty generic-pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A., for $1.23 billion.

Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio officially launched commercially on Sept. 3, 2015.

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.