The pharmaceutical industry faces significant scrutiny from regulators, governments, and consumers, under pressure to deliver innovative, life-changing drugs and with demands for increased transparency and accountability. By automating some of the lengthy, time-consuming, and expensive manual reporting needed to ensure compliance and safety, NEXS can save significant time and money, helping get drugs to market faster and safer.
Active pharmaceutical ingredients (APIs) are biologically active ingredients in a drug candidate that produce effects. All drugs are made up of the API or APIs and excipients. (Excipients are inactive substances that deliver the drug into the human system.). High Potency Active Pharmaceutical Ingredients (HP APIs) are molecules that are effective at much smaller dosage levels than standard APIs. They are classified based on toxicity, pharmacological potency, and occupational exposure limits (OELs), and used in complex drug development involving more than ten steps.
The drug discovery process ends when one lead compound is found for a drug candidate, and the process of drug development starts.
Once a lead compound is found, drug development begins with preclinical research to determine the efficacy and safety of the drug. Researchers determine the following about the drug:
Preclinical trials test the new drug on non-human subjects for efficacy, toxicity, and pharmacokinetic (PK) information. These trials are conducted by scientists in vitro and in vivo with unrestricted dosages.
One of NEXS Research & Development Group’s core businesses is clinical supply manufacturing and testing. Quality clinical supply manufacturing and testing services have ensured that products are produced and tested under strict batch records, standard operating procedures, and cGMP controls. Manufacturing operations are fully audited after clinical supply manufacturing and testing by the Quality Assurance Team.
Sterile pharmaceutical products are prepared by sterile filtering and then aseptically filling solutions into glass vials. After filling, vials can undergo lyophilization if desired. NEXS also has the capability to terminally sterilize aseptically filled solutions if desired. Batch sizes can range from a few hundred vials to up to 4,000 vials or 40 L of bulk solution (whichever is less), depending on the fill volume of the product. Differential air pressures, along with other measures, including cleaning verification and dedicated product contact equipment components, are used to prevent cross-contamination. Because our fillers use peristaltic pumps and a single fill needle, line losses are low compared to larger operations. Vial sizes processed range from 2 mL to 100 mL (up to 50 mL for lyophilized products) and fill volumes can range from 0.5 mL up to 100 mL for liquid products.
We are able to process controlled substances schedules I-V and most potent and cytotoxic materials. We routinely work with both large and small molecules.