Establishing Control Over the Manufacturing Process and the Quality of your Biologic

101679_Large-Molecule_1575263331When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control testing to generate the medicine responsible for this patient trust.

For the development of biologic medicines, the process of generating a quality product is less straightforward than that of a small-molecule medicine, like pain relievers such as aspirin. Selecting the right partner, such as Covance and its ‘Central GMP Testing Laboratory’ model, can smooth the path to validation and consistent manufacturing quality for your biologic.    Continue reading

How to Proactively Avoid the Common Pitfalls in Biologics Development

When developing a biologic, great science does not always translate into a great product. Doing the rights studies, the right way, is paramount to realizing the product’s potential. Knowing which studies to conduct, when to conduct them and interpreting the data in the context of the product’s development, can make the difference between success and failure.

oysterFor Biologics, “The Product is the Process”

Biological medicines, including therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins are large, complex molecules that cannot be fully defined by physicochemical analytical methods. They are manufactured from genetically modified living cells using processes that are usually complex. Biological medicines are often 200 to 1,000 times the size of small molecule drugs, and because of the biological nature of the starting materials, the manufacturing processes have inherent variability and product heterogeneity. Continue reading

A Well-Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

A Well Developed Regulatory Strategy is Key to Increasing Your Chance of Regulatory Approval

The level of investment required and inherent risks in development of today’s new and advanced biopharmaceutical products are greater than ever posed in the history of the industry.  Pharmaceutical products are more specialized, technology is more complex, the regulatory environment more tortuous, global markets for these products are more competitive and return on investment may be uncertain at the early stages of product development.  Additionally, new clinical development tools and regulatory principles, e.g., enrichment strategies, adaptive trial designs, breakthrough designation, are emerging that enable more efficient clinical development, as well as, more expedited approval pathways for new therapeutic approaches to disease management. Continue reading

Biosimilars Development Demands Expertise Across All Phases of Development

Biosimilars Development Demands Expertise This is an exciting time for biosimilars. Based on a recent MarketsandMarkets report, the global biosimilars market is expected to be worth $19.4 billion by 2014, growing at a CAGR of 89.1% from 2009 to 2014.

While the opportunity is immense, the risk involved with biosimilar development is still high with large up-front investment required and possible failure of the drug during development stages. Given the nature of biosimilars development, choosing the right CRO with capabilities across the drug development spectrum is critical to market success. Continue reading