Drug Development

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

Hazardous reagents can simplify processes and provide higher yields and purities.

The chemical distribution industry has formed an international chemical trade association to address global issues.

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

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

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.

Andrew Badrot, founder and CEO of Centroflora CMS, discussed the acquisition and technical transfer of Boehringer Ingelheim’s (BI) non-captive phytochemical API portfolio with Pharmaceutical Technology.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

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

More “me-betters” and more focused breakthroughs could enhance new drug development.

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.

The author discusses the collection and evaluation of data part of FDA’s definition of process validation.

DAVID LEAHY/GETTY IMAGESThe pharmaceutical industry has an important role to play in implementing solutions to global envi

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.

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.

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.

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.

Synthetic biology promises to drive tomorrow’s therapies, while continuous processing is already being used in some new drugs.