Outsourced Pharma White Papers

1. Strategies For Flexible Manufacturing 6/22/2020

   Biopharmaceuticals are increasingly complex and on shorter timelines to meet patient needs. Here's an in-depth look at the latest market drivers, approaches, and technologies in flexible manufacturing.

2. How To Avoid High Potency API Contamination 3/22/2019

   To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies. Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs.In this paper learn how to determine exposure potential and select the correct equipment and technology.

3. Business Continuity Program Helps Maintain Operations In The Face Of Crisis 5/5/2020

   Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

4. 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.

5. 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.

6. Optimizing Process Efficiency In Upstream Manufacturing 2/8/2019

   Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

7. Comparator Local Sourcing For Clinical Trials 8/24/2020

   This growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.

8. Towards A Better Process Outcome 8/12/2020

   In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

9. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins 10/2/2018

   This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

10. 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.