Webinars
Qualifying and Optimizing GC Instruments and Methods in High-Throughput Regulated Laboratories
Three key areas of focus for qualifying and optimizing instruments and methods in high-throughput, fast-paced regulated laboratories are: 1) Staying compliant with instrumentation qualifications, 2) Ensuring lab personnel are properly trained to perform methods and understand their purpose and intent, and 3) Making sure methods are easy to follow and contain all the pertinent information. ... Qualifying and Optimizing GC Instruments and Methods in High-Throughput Regulated Laboratories
LBP cGMP Characterization and Stability: Designing an Effective Testing Program on the Road to Commercialization
Once the science has determined the production strains targeted to treat the disease indication, there are many regulatory hurdles that must be overcome on the path towards clinical trials, and ultimately commercialization. Setting up an effective, compliant release testing and stability regimen is paramount. This talk provides detailed background on the following: Evaluation of successful ... LBP cGMP Characterization and Stability: Designing an Effective Testing Program on the Road to Commercialization
Extractables & Leachables Testing of Large Molecule Drug Forms
Large Molecule drugs, Biopharmaceuticals, or Biologics are a growing class of drugs in the Pharmaceutical industry. These drug forms include pharmaceutical products that are manufactured in, extracted from, or synthesized from biological sources. These drug forms offer the ability to treat medical conditions that traditional “small molecule” drug forms cannot. Biologics are comprised of living ... Extractables & Leachables Testing of Large Molecule Drug Forms
Analytical Support in the Development of Biologics
Life-saving protein-based therapeutics are becoming an increasingly important therapeutic option. Analytical methods are deployed from the earliest moments of discovery up through delivery of approved protein therapeutics to patients, ensuring a safe and effective supply of drugs. So what is the role of analytical chemistry in the evaluation of protein drugs? When are certain approaches ... Analytical Support in the Development of Biologics
Microbiome-Based Therapies: Setting up a cGMP compliant program within current regulatory frameworks
The microbiome has opened up new frontiers for the treatment of many human disease indications. After the science has determined the drug product targeted to treat the disease indication, there are several regulatory hurdles that must be overcome on the path towards clinical trials, and ultimately commercialization. Setting up an effective, compliant release testing and ... Microbiome-Based Therapies: Setting up a cGMP compliant program within current regulatory frameworks