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

Integrated Solutions: Combining Multiple Endpoints into a Single Study Delivers Greater Confidence

covance_knife“The whole is greater than the sum of its parts” is often quoted to inspire teamwork and synergy but it can also apply to drug development. Studies that assess endpoints in isolation have value and can achieve the desired outcome.  Yet, many times a more complicated picture emerges and assessing multiple endpoints in a combined study reveals a more holistic view.

Inspired by the 3Rs—reduction, refinement and replacement of animals used in safety testing—the possibility of integrating multiple endpoints into one study is shaping new best practices in early drug development. Integrated solutions can maximize the value of each study to provide a better understanding, reveal earlier decision points and produce greater confidence in clinical outcomes.

While the concept seems straightforward, it’s not only a combination of otherwise standalone studies. Integrated solutions require a unique blend of fit-for-purpose experimental strategies tailored to each unique drug development program and the relevant endpoints. 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

Shaping Global Standards for Bioanalysis

Global Bioanalysis ConsortiumWhen we provide sample concentration data for submission with new drug applications, clients have an expectation that those data will meet regulatory agency expectations for quality, accuracy, and precision. Those expectations have been evolving since the first US consensus AAPS/FDA workshop (Crystal City I) in 1990. Subsequent workshops and the resulting white papers have formed the basis for guidance documents on conducting method validations and sample analysis. These documents are published by regulatory agencies such as the US FDA and the European Medicines Agency. Continue reading

Biotherapeutics and Immunogenicity Implications in Drug Development

Immunogenicity

In contrast to new chemical entities, biotherapeutic drugs are potentially immunogenic, and, in rare cases, treatment with such products can lead to severe and devastating illnesses in humans. Therefore, the importance in understanding how immunogenicity affects drug exposure, efficacy, and toxicity at all stages of the drug development process can not be overstated.

There are more than 200 biotechnology products currently on the market with 400-plus additional therapies in clinical trials targeting diseases such as cancer, Alzheimer’s, rheumatoid arthritis, multiple sclerosis, and HIV/AIDS. In 2014, it’s predicted that 50% of the top 100 drug sales will be biologics, an increase of 28% from 2008. Continue reading

Why Some Sponsors are Considering Dedicated Resource Agreements

Many sponsor-CRO relationships are based upon one or more transactional agreements that are each focused on a specific project. Projects are offered by the sponsor and are generally bid upon by a number of different CROs. Once a project is awarded to a particular CRO, then that organization becomes responsible for the logistics, such as setting up the facility, making technology decisions, assigning staff, organizing the work flow, and ensuring compliance with appropriate regulatory guidelines. When the project is completed, the relationship between the sponsor and CRO ends, at least until the cycle of offering, bidding, and awarding has been repeated with a different project.

While this type of arrangement works very well for some sponsors, particularly those with small, well-defined projects, other sponsors find the transactional agreement presents challenges.

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Dried Blood Spot Technique Making a Comeback

DBP Punching CardIn recent years there has been renewed interest in the Dried Blood Spot technique for determining drug levels in blood samples. The advantages it offers – including less blood per sample, easier logistics due to longer shelf life, non-hazardous samples, storage at ambient temperature, and reduced costs – are helping Dried Blood Spot gain momentum as a popular alternative to the traditional plasma/serum blood sampling technique.

Although Dried Blood Spot has been in existence for almost 50 years, it had not been widely utilized within the drug discovery and development process due to limitations of the method. In the past, analytical technologies were not sensitive enough to obtain reliable, quantitative data from such tiny blood samples. However, recent advancements – mainly ultra-high performance liquid chromatography and mass spectrometry (LC-MS/MS) – have overcome this limitation, enabling Dried Blood Spot to not only screen for the presence or absence of a particular molecule, but also to quantitatively determine the extent to which a molecule is present. Continue reading