Dosage Forms

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

Dedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

Tablet presses require regular inspection and maintenance to prevent premature wear and tableting problems.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.

Expanded systems integration, serialization, and supply chain connectivity will enhance productivity and support counterfeit prevention.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

The reporter bioassay, used to evaluate ADCC activity of therapeutic antibodies, complements the classical ADCC assay.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

Novartis announced on Jan. 5, 2016 that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.

Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.

The DF30Plus, a new version of Aptar Pharma’s aerosol metering valve for pressurized metered dose inhalers (pMDIs), incorporates an elastomeric cyclic-olefin-copolymer (COC) neck gasket.