INSIGHTS ON DOWNSTREAM MANUFACTURING

• Vaccine Manufacturing: Collaboration Helps To Overcome Vaccine Process Challenges

  Due to the sheer number and diversity of today’s promising vaccine types, and many competing cell culture, production and purification options that are available, development of large-scale vaccine production process remains an inherently
  challenging undertaking. This white paper showcases collaborative technology-development efforts carried out by the DiViNe consortium to advance the use of an innovative affinity chromatography platform during vaccine manufacturing. This paper also discusses how long-term partnerships with strategic technology experts can help overcome inherent issues that arise as promising vaccine candidates move through scaleup, from proof-of-concept through commercial-scale manufacturing.

• The Roadmap To Outsourcing Vial Fill/Finish

  Outsourcing a fill/finish project can be a challenging journey without a formal guide to the “right” path. There are several key milestones along the way that determine your outcome and this article will guide you through them.

• Flow-through Chromatography And Adsorptive Depth Filtration For Continuous Bioprocessing Applications

  Current technologies for downstream processing such as clarification and chromatography can be adapted to make them more suitable for continuous bioprocessing applications. This white paper describes the use of these technologies to remove impurities in a manner compatible with a flowthrough, continuous process.

• Process Optimization And Scalability Evaluation Of Pellicon® Capsules For Single-Pass Tangential Flow Filtration Of mAb-Based Biomolecules

  SPTFF has been successfully implemented between unit operations throughout the downstream production process of biopharmaceuticals. Its value lies in the simplicity of operation as well as its small footprint and equipment requirement. This document describes the principles of SPTFF and how to determine operating conditions to achieve the target concentration factor with single-use Pellicon® Capsules.

• Strategies To Develop Lipid-Based Drug Delivery Systems And Oral Dosage Forms

  Liquid-filled capsules (LFC) are the primary delivery platform for oral delivery of lipid formulations which includes both softgels and liquid-filled hard capsules. Liquid-in-bottle is another avenue for delivering lipid formulations. Proper deployment of these technologies can provide formulators with effective delivery platforms during early-phase development and commercial products. In this webinar, industry experts discuss strategies to develop lipid-based drug delivery systems (LBDDS) for oral delivery. The experts share the fundamental principles, advantages and disadvantages of different dose forms for LBDDS and considerations for selecting a suitable dosage form for early phase development programs through commercialization.

• Scale Your Process Directly From 3L To 2,000L Blindfolded

  In the biotech industry, you need to move quickly and use resources efficiently to advance a drug candidate into the clinic and ultimately onto the market. Being able to quickly produce a batch at the right time and at the right size is essential to support development and get to the finish line faster. We developed a strategy to enable a direct, efficient and robust tech transfer of a monoclonal antibody production process from a 3L bioreactor to 2000L without the need for any intermediate volumes.

• How To Minimize API Loss: A Case Study In Aseptic Fill/Finish

  With API (active pharmaceutical ingredient) values continuing to climb as production scales conversely drop, it is time to rethink our aseptic filling processes to minimize API loss.

• Development Of A Modified Purification Process For A Monoclonal Antibody Therapeutic-Yield Improvement

  A Mab product had been manufactured at the 2,000L scale and production at the 10,000L cGMP manufacturing scale was planned. Read how they improved yield of Mab product from bulk harvest by 1.8 fold by simplifying the downstream process in addition to eliminating the use of resins that were difficult to pack and resulted in declining yields with short life cycles.

• Development Of A Drop-In Purification Step For Removal Of Aggregates From An Antibody Therapeutic

  A client was engaged in large scale cGMP manufacturing operations at a major CMO and their product contained high levels of aggregate following an affinity capture step. Subsequent chromatography steps reduced the aggregate level to acceptable levels but product losses were encountered in elution buffers, and stat in-process assays. Read how they were able to reduce aggregate level and simplify the downstream purification process.