Drug Development

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.

New formulations that enhance bioavailability, optimize drug-delivery profiles, reduce dosing frequency, or improve patient experience have the potential to deliver quicker returns on investments than developing a completely new drug.

BASF completes sale of custom synthesis business and parts of its API business to Siegfried Holding.

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 the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

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.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

The company will showcase its range of drug packaging and delivery systems as well as launch a new ready-to-use validated packaging component.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

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.

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Matt Shaffer, manager, formulation development, Bend Research, a division of Capsugel’s Dosage Form Solutions business, and Martin Koeberle, PhD, head of analytical development and stability testing, Hermes Pharma, spoke to Pharmaceutical Technology about the different approaches used in taste-masking and the challenges involved.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

More complex drug candidates require more specialized and selective chemistry.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.