APIs and Excipients

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Stephen Hoag, a professor at the University of Maryland (Baltimore), and a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) offers a brief update on issues, and NIPTE’s database project.

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

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.

Analytical laboratory equipment adapts for new realities of downsizing, outsourcing, and speed demands.

Hazardous reagents can prove to be faster, simpler, cheaper, and greener.

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.

Ashland Chemical’s Calvert City, KY, facility is the first in the US to receive EXCiPACT certification for GMPs of pharmaceutical excipients.

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.

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.

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.

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.

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.

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

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

BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.

Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.