Contract Manufacturing, Biopharmaceutical Production

Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.

A monoplant may offer greater supply security and flexibility for specialist medicines.

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

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

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.

Pharmaceutical Technology spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development, validation, and sample analysis services, about best practices to ensure that biologics are safe and effective.

Suppliers set the tone for 2019 with strategic expansions, investments, and acquisitions.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

Requirements for virus filtration must be considered in developing continuous downstream processes.

Contract development and manufacturing organization (CDMO), Yposkesi, has entered into an agreement in principle with Axovant Sciences.

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

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.

The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.

A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

The company is certified as a manufacturer of pressure vessels and components for use in China.

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

CMOs have been active over the past year in expanding their biologics production and capabilities.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

This article highlights 15 years of changes in biopharmaceutical manufacturing.