Process Development

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

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

The new column features Natrix’s signature macroporous hydrogel.

Talks will explore key trends and issues in the pharmaceutical space and address the “latest industry buzz.”

Optima Pharma is exhibiting a range of technologies from sterile-filling and freeze-drying solutions to isolators and restricted access barrier systems.

Hüttlin GranuLean offers a compact solution for high-quality granulation processes.

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.

The countdown has begun for one of the biggest trade shows for the process industry.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

Medicago's new production facility will make plant-based vaccines and therapeutics.

Economic benefits, equipment availability, research results, and FDA support are driving progress in continuous processing.

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

Virtualization has been mainstream in information technology (IT) for decades.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

In-silico design facilitates process optimization and evaluation of process control strategies.

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Use of modeling software can help improve process understanding, and can be used in open- or closed-loop control.

Real-time, noncontact imaging and spectroscopy techniques provide insight into pharmaceutical processes.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

With a quality-by-design approach, robust processes can help deliver quality product consistently.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

With a quality-by-design approach, robust processes consistently can help deliver quality product.