Pharmaceutical Technology, November 2021 Issue

Investing in formulation strategies earlier on in development will maximize the chance of success.

Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms.

Alternative drug delivery approaches are promising, but due to their complexity, they need to be sufficiently justified.

Advances in simulation and the development of digital twins.

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.

Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.

Machine and material innovations yield more efficient, sustainable processes for pharmaceutical packaging, including vaccine vials.

Best practices help mitigate generic drug shortages.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

SEDDS and SMEDDS improve solubility and permeability while expanding efficacy and applicability.

Manufacturing capacity expansion is high on the agenda for many bio/pharma companies and service providers in Europe.

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.

WL-1-RT Wraparound Vial Labeling Machine can label up to 600 vials per minute.

The ADCC+ Cell Line is designed for rapid identification of clones expressing high levels of recombinant therapeutic proteins.

The Mettler-Toledo StarWeigh checkweigher provides fill level measurements of products like glass and plastic bottles, vials, and ampules.

The ROSS Ribbon Blenders ensures even mix and consistent batches.