Cynthia A. Challener

New investments, expansions, and company rebranding are discussed at CPhI.

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Adding light scattering to size-exclusion chromatography (SEC) can maximize the benefits of SEC.

Careful selection of downstream processing conditions is a must.

Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.

Methods must be suitable at each development phase, robust, and effective on multiple platforms.

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

Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.

Industry suppliers describe new technologies to facilitate downstream processing.

New test methods can provide improved quality and efficiency, but they must be validated to demonstrate equivalency.

Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

New human and plant-based expressions systems can enable faster product development and improve quality at potentially lower costs.

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

The targeted delivery of cytotoxic drugs using antibody drug conjugates would not be possible without effective linkers to connect and then release the key chemical and biological materials.

Advances in instrumentation, software, and methodologies provide more information than ever on the higher-order structure of proteins.

Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

Techniques to enable the design and formulation of stable, protein-based therapeutics.

Clinical-stage biopharmaceutical company Ambrx leverages its site-specific bioconjugation technology through partnerships.

NPS Pharmaceuticals uses its expertise in development, regulatory compliance, and commercialization to bring to market products with orphan drug status.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

Kevin Ott, executive director of the Bio-Process Systems Alliance, discusses the latest trends and issues surrounding single-use technologies and the role of his association.