Bioprocessing White Papers

1. Vaccine Manufacturing: Collaboration Helps To Overcome Vaccine Process Challenges 1/23/2020

   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.

2. Developing An Accelerated And More Cost-Effective Single-Use Adenoviral Vector Vaccine Manufacturing Process Through Public-Private Collaboration 1/23/2020

   while remarkable progress has been made in eradicating devastating diseases such as smallpox and polio, the global population remains at risk due to difficulties accessing vaccines, shortages in supply, slow responses to outbreaks and pandemics and the presence of emerging pathogens. In this whitepaper, we describe our collaboration with the Jenner Institute, Oxford University in the United Kingdom to develop an optimized, single-use GMP process for manufacturing adenoviral vector-based vaccines.

3. Flow-through Chromatography And Adsorptive Depth Filtration For Continuous Bioprocessing Applications 1/14/2020

   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.

4. Freezing And Thawing Of Protein Solution 12/19/2019

   The process of freezing could lead to a denaturation of the protein. In fact, parts of the protein solution will always show less activity based on the stress the protein is exposed to during freezing and thawing. It is therefore important to optimize the freezing and thawing process in order to minimize activity loss.

5. Advantages Of Single-Layer Film Vs. Multilayer Film For Use In Bioprocessing 12/17/2019

   Now more than ever, speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population. This paper takes a closer look at plastic storage bags for bioprocessing applications, the challenges associated with them, and technology developments to address these challenges and focuses on materials that enable a shift from multi-layer to single-layer storage solutions.

6. Employing Single-Use Technology To Control Frozen Bulk Drug Storage: The Cold Hard Facts 12/17/2019

   The traditional approaches for primary packaging in frozen applications have been bottles and stainless steel cryo vessels. While each has its strengths, both have significant shortcomings. This paper addresses the challenges of bulk drug substance (BDS) storage, shipping, and other critical factors users must consider in deciding whether and how they will adopt the technology. Also highlighted are specific options to consider in moving toward single-use drug substance storage.

7. Cold-Chain Bioprocessing Readiness: Mitigating Risk And Protecting Pharmaceutical Products 12/17/2019

   Many pharmaceuticals — monoclonal antibodies, vaccines, and patient-specific therapeutics — must be reliably stored and transported at sub-zero temperatures, requiring a robust cold chain that continues throughout downstream processing. This white paper addresses the concerns of development laboratories, contract manufacturing organizations (CMOs), and contract research organizations (CROs) and explains several factors they should consider when expanding operations and selecting single-use systems for cold-chain bioprocessing.

8. Bioreactors And Fermentors: Tools For Resolving Cultivation Bottlenecks 12/10/2019

   In this white paper we explain the key characteristics of stirred-tank bioreactors and which organisms are typically grown in them.

9. Current Perspectives On Biosimilars 12/1/2019

   Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. In this paper the biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. In addition, an overview of the biosimilars market, pipeline and industry targets is discussed.

10. Continuous Flow Manufacturing Of Pharmaceutical Ingredients 11/25/2019

    Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.