Outsourced Pharma White Papers

  1. Golden Retriever Lifetime Study: 5 Years Of Vet Health And Biobanking Progress 2/11/2019

    An overview of a prospective cohort study of some 3,000 young Golden Retrievers, and how extensive data and biological samples will be used for future analyses of major diseases, disorders, or conditions..

  2. Lyophilization Of Highly Potent Drugs: Facility and Equipment Design Elements 5/24/2019

    Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

  3. Using A CMO To Streamline Process Characterization 3/19/2019

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

  4. Quality Matters – SEC Analysis For Antibody Aggregates 10/25/2019

    Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

  5. The Use Of Cell-Free Synthesis In The Future Of Modern Medicine 4/2/2019

    Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.

  6. API In Capsule Vs. The Lost Art Of Formulation Development 5/5/2020

    Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes. By Todd Daviau, Ph.D

  7. Unifying Cell Therapy Logistics And Manufacturing 2/24/2020

    The supply chain and logistics for cell and gene therapies are especially critical to ensure the right patient gets the right treatment at the right time. Collaboration is the key to solving challenges such as data management and process variability, as stakeholders work towards a common goal—getting these life-saving treatments to the people who need them.

  8. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics 9/11/2019

    Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  9. More Efficient Bispecific Antibody Purification With Fewer Steps 2/28/2019

    A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

  10. Telltale Signs You’re With The Wrong CDMO 4/27/2020

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.