Active Pharmaceutical Ingredient Consulting

Conduct Research

• Winning the Space Race
  By Jason Kamm, Tunnell Consulting, Inc. ICH (the International Conference on Harmonization, ) Q8 and the Quality by Design (QbD) guidance issued by the FDA offer pharmaceutical manufacturers a significant opportunity to design quality into their manufacturing processes instead of inspecting...
• Winning the Pharma Cap Spending Game
  and high-efficacy therapies is increasing demand for sterile active pharmaceutical ingredients (API), which in turn is driving growth in the contract primary manufacturing market. These manufacturers are also adding capabilities in chiral chemistry, olignonucleotides and peptides, high-potency, hazardous...
• Potent Protection
  facilities. Included was a tour of a new oral dosage form R&D facility, which is expected to open later this year. Built using modular construction, the new facility will include areas where new drugs ad active ingredients will be evaluated, clinical-trial-scale quantities of new compounds...
• Controlling Crystallization through Modeling
  impacts downstream processing such as filtration, centrifugation and milling. Size distribution also affects the rate at which a powdered material dissolves in the body. Thus, greater control of CSD leads to better control of the release rate of active ingredients. In spite of its importance, CSD...
• Chiron's Curse
  the active ingredient is, or what precisely drives the process. As a result, there s a major ongoing effort where regulators say 'the product is the process, and you re stuck proving no easy feat that the process is the same as when you did your original clinical trial, and that it remains...
• Drug Makers Fight Back!
  Security (DHS) have paid enough attention to these issues," Livingstone says.FDA admits that vulnerabilities continue to run throughout the supply chain. Imported raw materials remain one Achilles heel, since over 80% of active pharmaceutical ingredients (APIs) used in the U.S. are imported...
• Drug Delivery: The "Great Equalizer"
  technology transfer from the licensor to the innovator. This raises more delicate collaboration issues than, say, the outsourcing of a mature or generic active pharmaceutical ingredient. Shown here, assembly cleanrooms for ITI’s intranasal delivery device. Photo: ITI. Within the old...
• Chiron's Curse
  stronger Risk Assessment.”Complex, primitive processNo doubt the inherent risk and complexity of vaccine manufacturing also led to some of the issues at the facility. “Vaccines are not like chemical entities that can be assayed,” says Gerson. “Often you don’t know what the active ingredient...
• Extending the Validated Workplace
  engineering. The facility uses environmental controllers from Johnson Controls and a variety of process control units run by InTouch. Production typically involves mixing active pharmaceutical ingredients into solution, while another part of the plant produces IV bags and closures, Collins says. The two...
• Lessons from Heparin
  of Life Science Auditing at the consulting firm SGS (Princeton, NJ). This holds true not just for the oversight of active ingredients, but excipients as well. Many major multinationals have already taken these steps, he says. Quality Contracts: The Devil's in the Details. Contracts are also...

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