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The Evolution of Predictive Toxicology: Improving Predictivity Using New-Approach Methodologies

A pharmaceutical’s approval for commercial distribution is contingent on submission of pharmacological and toxicological safety data as defined by regulatory agencies such as the US FDA and ICH. Guidances state that such data can come from in vivo or in vitro studies. The current paradigm works well for collecting critical data about, e.g., a drug’s pharmacological effects and mechanism of action (MoA). However, increasing evidence points to current methods’ inadequacy for predicting a drug’s risks to human patients. Such limitations…

Accelerating Cell Line Development with an Efficient, Combined Platform Approach

The determination of product critical quality attributes (CQAs), key process parameters and indicators (KPPs and KPIs respectively) is a critical step for process efficiency during cell line development. Thousands of clones are typically screened with the goal of finding those that are stable, produce high yields of the bioproduct and exhibit desired CQAs. Screening and process optimization activities are typically carried out at the small scale in bioreactor cultures and are aimed at ensuring that results translate to larger bioreactor…

Selecting the Best Transfection Method – When to Use Transfection Reagents, Viral Transduction or Electroporation

No single delivery method is ideal for all situations, but researchers may routinely employ a suboptimal approach for the sake of familiarity or to avoid any start-up costs associated with new methods. In this white paper, we will describe three methods (chemical, electroporation and viral transduction) and highlight the Mirus Bio TransIT® transfection reagents and Ingenio® EZporator® Electroporation System, which are both easy to use and cost-effective.

Cell and gene therapy processing: Iteration or innovation?

Cell and gene therapies represent the “next evolutionary step” in bioprocessing incorporating disruptive technologies on a well-proven manufacturing base, agree panelists at BPI Europe. “Is is cell and gene therapy really the shiny, bright object on the field that breaks all the rules and disrupts everything? Or is it just an iteration of the same principles that we had before, with slightly different practices?” That was the question Nadine Ritter, president and analytical advisor at Global Biotech Experts posed to…

Merit implementing digital tech to speed up facility builds

Merit says the adoption of digital technology has enabled it to construct biopharmaceutical facilities three times faster than the industry standard.   According to Merit, a major issue in the construction space is the scarce implementation of digital technologies. However, the firm decided to rethink, reengineer, and reform how to deliver a construction project,  leading to the creation of an integrated IT platform and digital form of construction using Revit, a software to plot and track stages in the building’s…

Avantor and Cytovance team to address $1.5bn plasmid DNA market

The advanced therapy pipeline is driving demand says Avantor, which has collaborated with Cytovance to offer an expanded plasmid DNA service.  “The demand for plasmid DNA, especially at cGMP-grade, supporting advanced therapeutic modalities is growing rapidly,” said Ger Brophy, EVP of Biopharma Production at Avantor.  He told BioProcess Insider it is being driven by the growing, early-stage pipeline of cell and gene therapies, DNA and RNA vaccines, and gene editing technologies. “We estimate that the total addressable market for plasmid DNA…

Standardized handling practices would help cell therapy sector, study

Cell therapy developers need uniform handling, storage, and usage methods say the authors of a new report examining how the market for centrally manufactured products is evolving.  The study – published in the Journal of Translational Medicine in April – looked at the role medical center processing labs play in cell therapy distribution and usage and concluded that such facilities will be a potential bottleneck unless handling processes become more uniform.  “Cell processing laboratories at many academic medical centers are…

Lithuanian CDMO Northway invests $40m in MA plant

Northway will open a facility in Waltham offering microbial and mammalian cell line development and upstream and downstream process advancement. The contract development manufacturing organization (CDMO) headquartered in Vilnius, Lithuania opened its doors to international ministers for a tour of its 30,000 square foot sister facility in Waltham, which is expected to be fully operational by the end of 2022. “We selected Waltham because of its close proximity to the Boston biotech cluster, one of the premier global life sciences hubs…

Korean CDMO enters US with BMS plant buy

Lotte is set to buy Bristol-Myers Squibb’s (BMS) facility in East Syracuse, which it says will serve its CDMO business in the US. The deal, which is subject to regulatory approvals and other closing conditions, sees Korean-based firm Lotte Corporation acquire BMS’ New York site’s operations and assets. This includes the equipment, property, plant, workforce, and technical capabilities. “This transaction is consistent with our longstanding goal of creating a manufacturing network to best support the ongoing needs of the business…

PCI forks out $100m to expand New England plant

The Philadelphia-based CDMO will expand its capacity in sterile lyophilization technology and aseptic liquid fill/finish to stay ahead of demand. PCI Pharma Services says the investment of $100 million at its Bedford, New Hampshire campus will include a 50,000 square-foot facility, which will enable the contract development manufacturing organization (CDMO) to expand its service offerings in biologics packaging and manufacturing. “We are excited to introduce clients to our newest facility, which is part of our broader strategy to provide integrated…