Bioprocessing White Papers

  1. Quality Results Faster With Integrated Pharmaceutical Development Platform

    How an integrated pharmaceutical development platform can meet the needs of both analytical development and QC teams through shorter turnaround times, fewer repeats and higher quality.

  2. Manufacturing Of Sterile Aqueous Suspensions: A Primer

    Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

  3. Choosing The Best Sterile Dosage Form For Your Phase I Clinical Supply Needs

    When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.

  4. In-House Versus Outsource: A Decision-Making Guide

    Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

  5. The Right Upstream Bioreactor Techn For Industrial Scale Viral Manufacturing

    Solving the bottleneck in gene therapy of manufacturing of viral material at sufficient cost and scale.

  6. BioProcess Containers – Materials Of Construction

    Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).

  7. Accelerate Your Process Development With High-Throughput, Single-Use, Fully Automated Bioreactors

    Biopharmaceutical R&D teams everywhere face the same dilemma in the development of biologics and vaccines: they must increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.

  8. Advances In Single-Use Technologies For Cell Clarification

    One of the major challenges in batch mammalian cell clarification is cost-effective improvement in filtration in the face of high cell densities. Single-use technology has serious benefits for flexibility in production, pilot or clinical batches, but with existing filtration equipment, the economic benefits have not been fully realized at volumes < 2,000 liters.

  9. Reducing Total Cost Of Ownership In Media Filtration

    The production of monoclonal antibodies (mAb) and recombinant proteins has undergone significant progress in recent decades. Higher titers and increasing cell densities present challenges to upstream and downstream bioprocessing groups alike. In downstream processing, this challenge is quite clear (i.e., purification of larger product masses with currently available equipment/technologies is an on-going industry topic), but these changing conditions bring major challenges in upstream bioprocessing as well.

  10. Aseptic Sampling Product Manager On PDA Technical Report No. 69

    This paper delves deeper into aseptic sampling devices to explain how they offer superior performance in the effort to control contamination.