Formulation and Drug Delivery

The authors discuss a novel particle engineering technology based on mechano-chemical activation.

Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.

Working with biological matrices and understanding the intended use are crucial.

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

CMO executives share their opinions on where outsourcing is going and what is driving market change.

After launching a new mammalian cell platform, FUJIFILM Diosynth Biotechnologies U.S.A., has acquired fast-track vaccine manufacturing knowhow and a major presence in Texas’ emerging biocorridor with Kalon, its first acquisition.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

Sanofi has entered into a strategic manufacturing collaboration with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies (mAbs).

Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.

Mexichem announced that it acquired the distribution and sale license for HFC-227ea/P from Du Pont.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.

Tocophersolan or TPGS was developed 60 years ago as a water-soluble form of vitamin E. The author gives an overview of TPGS, including its interesting properties, examples found in the literature, and a brief summary of the regulatory status and marketed formulations.

Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

This year’s Drug Delivery & Formulation Summit included discussions on solubility, drug penetration, and new approaches to technology.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

Atlangram will have access to Carlina’s lipid nanocapsule technology platform Soludots under the terms of the agreement.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Sandoz announces their version of filgrastim, a follow-on biologic for the treatment of neutropenia, is as safe and effective as Amgen's Neupogen.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Dual sourcing is one of many possible solutions to securing the supply chain.

In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.