Drug Development

The company is the first multi-site excipient supplier to achieve accreditation across production facilities.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.

A new study from the United States National Institutes of Health (NIH) found that pairing the antidepressant amitriptyline with drugs designed to treat central nervous system diseases, enhances drug delivery to the brain by inhibiting the blood-brain barrier in rats. The blood-brain barrier serves as a natural, protective boundary, preventing most drugs from entering the brain. The research, performed in rats, appeared online April 27, 2017 in the Journal of Cerebral Blood Flow and Metabolism.

Catalent combines its formulation expertise, manufacturing excellence and particle size reduction technologies to provide a broad range of solutions in the development of inhalation and nasal drug products.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

The funding allows the company to broaden its range of services and finance its move to new laboratory facilities in the Illkirch-Graffenstaden innovation park in northeast France.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).

The project will foster the translation of nanomedicine applications for the treatment of cardiovascular diseases.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

FDA is in the center of the debate over developing and pricing new cancer therapies.

Researchers continue efforts to overcome challenges of effective oral delivery of biologic drugs.

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

Design of experiment plays a crucial role in the optimization process of formulation development.

David Fulper, PhD, director of technology support at Catalent, shares insights on the challenges and opportunities for cannabis-based therapeutics.

Anil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.

Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Advances in process analytical technology have been achieved, but significant challenges remain.

This article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.

Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.

A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.

Under the agreement, Laurus Synthesis will provide chemistry development services and manufacturing in support of an upcoming clinical trial evaluating EPX-100 in adolescents suffering from Dravet syndrome.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

Excipient manufacturer adds three tablet binding and disintegration products.

Human antibody for Zika virus could help in the treatment and prevention of the infection.