With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.
While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?
4SC AG, a clinical-stage biopharmaceutical company partnered with Thermo Fisher Scientific Pharma Services, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.
Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed to market.
Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.
This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.
This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
It’s been more than 30 years since monoclonal antibodies (mAbs) were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.
Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.
How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time to market.
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