Process and Scaling

Rockwell Automation’s updated FactoryTalk AssetCentre software supports several new types of production assets.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

The UK’s Centre for Process Innovation is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

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

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Boehringer Ingelheim plans to develop and test new strategies at its Solids Launch facility.

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

The acquisition will allow Lonza to further develop technology for scalable autologous cell-therapy manufacturing.

Syngene International’s Jegadeesh Thampi will discuss the significance of engineering data generation to develop robust, safe, and reproducible processes on Oct. 11, 2018 at CPhI Worldwide.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

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.