APIs and Excipients

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

Antibody-based drugs offer new mechanisms of action and greater specificity.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

Demand for highly potent APIs continues to rise.

The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.

An advanced combination polymer for enteric coatings has been launched by Evonik and will be showcased during AAPS PharmSci 360 in Washington D.C.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.

At this year’s CPhI Worldwide congress in Madrid, Spain, Archer Daniels Midland Company (ADM) will present its range of products spanning probiotics and microbiome solutions to highly purified, injectable-grade vegetable oils.

Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.

Integration of new modeling and analytical tools with flow chemistry are notable trends.

CPhI releases the bio trends portion of its annual report, which predicts an increase in bioconjucation expertise and biopharma productivity over the next five years.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

Omya will showcase Omyapharm 500-OG (calcium carbonate and tribasic calcium phosphate) at CPhI Worldwide in Madrid, Spain, on Oct. 9–11, 2018.

The company will showcase its gelatins for advanced pharmaceutical and biomedical applications at CPhI Worldwide on Oct. 9–11, 2018 in Madrid, Spain.

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.