Top Downstream Process Articles of 2021
Don’t miss our top articles on downstream processing for 2021! I have compiled a list of our most popular articles from 2021 in alphabetical order.
Addressing Downstream Throughput Bottlenecks with Rapid Cycling Protein A Based Fiber Chromatography
Faster process times and increased flexibility in manufacturing continue to be key drivers in both upstream and downstream processing. New technologies are needed to address bottlenecks and to infuse more flexibility in process development and manufacturing. For downstream, chromatography purification can be a resource intensive step and a source of bottlenecks due to decreased throughput…
Addressing the increasing demand for single-use technologies and supply chain shortages with future proof systems
In this podcast, we talked with Phil Sanders, Biotech Chief Innovation Officer, Agilitech, about the increase in demand for single-use equipment and consumables and how this has led to supply chain shortages. We also talk about how to address these issues by incorporating strategies like being brand agnostic and designing systems that are future proof…
The BioContinuum™ Buffer Delivery Platform Provides Solutions to Costly Buffer Management Pain Points
Buffer management is a significant logistical challenge in biomanufacturing and is the cause of many bottlenecks. While it is an essential function in downstream processing, it does not provide added value commensurate with the level of footprint, labor and equipment investment required. While buffer preparation itself isn’t overly complex, the volume and number of buffers required create a challenge. On average, a downstream process will use 15 unique buffers and require 5-10 liters of buffer per liter of bioreactor harvest. In addition, buffers have critical quality attributes for process performance that must be met…
Downstream Manufacturing of Gene Therapy Vectors
The downstream manufacturing process takes the output from upstream operations and transforms it through multiple steps into a viable drug product ready for administration to patients. The major challenge in downstream processing is to maximize yield while meeting both product and impurity specifications. Viral vectors destined for clinical use must comply with regulatory standards for product safety and potency and this means contaminants must be removed and impurities controlled…
Driving Efficiency and Ingenuity with an OPC Platform
The regulatory approval of several oligonucleotides over the past five years – combined with the recent headlines around rapid COVID-19 vaccine development – has created significant interest in the oligonucleotide (DNA/RNA) segment of the scientific industry. This includes everything from antisense oligonucleotides (ASOs) to lengthy gene transcript mRNA, as well as shRNA (small hairpin RNA), siRNA (small interfering RNA), CRISPR/Cas9 and anti-miR (anti-micro RNA)…
Evolving Beyond the Status Quo with Next Generation Buffer Prep Solutions
In this podcast, we spoke with Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America about buffer prep and delivery systems. We discussed current pain points and how next generation buffer prep solutions can greatly improve upon the status quo, including increasing the use of automation and remote operation, while reducing the overall footprint, labor and cost associated with more traditional approaches…
Future-proof Bioprocesses: Flexible Single-use Technology that Adapts to an Evolving Industry
The one constant in biopharmaceutical manufacturing is change. There is an ever-present need to adapt to new therapeutic modalities, more cost-effective approaches, higher product demands, and now a worldwide pandemic. Thus, the best way to ensure efficient biomanufacturing is to future-proof bioprocesses with flexible systems that enable companies to respond to changing priorities, new opportunities, and increasing demands…
Integrated Freezing Solutions to Minimize Risk and Preserve Product Quality
In this podcast, I talked with Claire Jarmey-Swan, Global Product Manager, Pall Corporation about the evolution of freeze-thaw technologies and how these new methods can streamline the process, minimize loss and maintain the highest product quality…
Mastering the Fundamentals of Oligo Development
With over 300 candidates in clinical trials, oligonucleotides are one of the most promising therapeutic modalities and for the foreseeable future – and solid phase synthesis remains the gold standard approach for manufacturing. Benefits include the relative ease of developing a synthesis route, the straightforward path to scale-up and improved in-process controls. For all the complexity that exists in oligonucleotide development – from end to end – a mastery of synthesis fundamentals can go a long way toward a successful run…
OCELOT™ System Control Provides Flexible Automation for Process Precision
The biopharma industry has continued to embrace automation as a key part of creating more efficient, cost-effective manufacturing. There are many options for how to automate systems, but a universal requirement is the need for a responsive, built for purpose automation software. In most cases automation software provides a single interface for all applications, while this may seem convenient, it often can’t be configured to meet an end users’ exact process or mode of operation…