Process and Scaling

Intensified and distributed manufacturing approaches create flexible, local capacity.

The Testa Center in Sweden provides access to equipment and expertise to help bridge the gap between biopharmaceutical discovery and industrialization.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

Advanced manufacturing technologies are available, but challenges need to be addressed.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

The new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

A holistic approach to validation and quality assurance is essential.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

As biopharmaceutical process development advances, a more collaborative and knowledge-based approach, driven by better analytics and high-throughput system integration, is reducing the risk of failure.

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

The manufacture of gene therapy vectors is shifting to more modern technologies.

Industry experts discuss challenges and best practices for scaling up manufacturing under a short deadline.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.

Regulatory, analytical, and process concerns must be taken into account.

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Regulators have exaggerated expectations for simulated media fills.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.