CMOs can empower their sponsors or customers to conduct many of these activities on their own products or processes through better data transparency.
Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.
To allay fears about manufacturing changes, valuable tools are now in places by the FDA to facilitate these transitions. By not understanding the availability and value of these resources, manufacturers are making a sizeable mistake that could potentially impede the industry’s passage into the next phase of modernized manufacturing.
A solution to break down the silos that exist in the early stages of drug development could be what researchers need to facilitate—and expedite—the delivery of safe, effective drugs.
While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. To address this issue without preventing legitimate patients from receiving their necessary medication, Grünenthal set out to create an abuse-deterrent formulation with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.
For small biopha innovators, steep development costs are compounded by the fact that large molecules are becoming increasingly complex and present serious clinical or manufacturing problems.
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
When a clinical trial progresses, the formulation itself and the dosage form may change. As a result, sponsors may also want to consider the desirable commercial format in later stage clinical studies.
In order to ensure a smooth development and clinical process, companies must carefully plan their activities with regard to the innovator biopharmaceutical.
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