Outsourced Pharma White Papers

  1. Can You Afford Not To Outsource Buffer Preparation? 2/6/2020

    The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

  2. 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.

  3. Is Your CMO Ready For Serialization And Aggregation? 3/20/2019

    While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

  4. Robust Business Continuity Program Helps To Maintain Operations In The Face Of Crisis 5/5/2020

    Experts at Cytiva provide 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.

  5. Flow Chemistry: Scale-Up Solution For Modern API Manufacturing 2/20/2019

    Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

  6. Addressing New Chromatography Challenges With Fiber Absorbents 6/2/2019

    An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

  7. Microtableting: Going Small To Create More Targeted, Effective Therapeutics 5/5/2020

    The desire to create more targeted, effective therapeutics with fewer side effects has driven drug formulators to expand into more technically demanding areas over the past decade. Microtablets are one result of this burst of creativity and engineering expertise. Going small opens up numerous new delivery options, but also creates additional challenges for drug formulators and manufacturers.

  8. Increasing Productivity In Hydrophobic Interaction Chromatography (HIC) Using Capto Resins 2/27/2020

    Downstream processes for biomolecule purification are becoming more complex. Challenges include increasing titers from upstream cell culture, greater diversity of target molecules, and a need for better productivity. HIC has characteristics designed to solve these challenges. In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

  9. Component Selection: The Key To Your Program Success 10/1/2019

    The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.

  10. How Buffer pH And NaCl Affect Size Exclusion Chromatography 4/22/2020

    Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.