In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.
Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.
Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?
Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.
The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically.
Understand Capsugel’s best practices for mitigating risks and ensuring the quality, safety and traceability of empty capsule products and how their programs and processes actually benefit the companies and customers they work with.
Researchers today have more information available to them than ever before. Patents, publications, Electronic Lab Notebook (ELN) entries, internal and external databases, and countless other sources all offer insights that can catalyze discovery. The challenge is finding the right information at the right time.
Contracting an in-country clinical depot helps bring costs and timelines under control.
EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPac single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight.
Pharmaceutical companies work throughout their supply chain in a field dominated by regulations and demands for high quality.