This week’s headlines include: How is the Inflation Reduction Act affecting biotech investment?, EU regulator backs use of Merck’s viral infection drug, Thermo Fisher Scientific to buy Olink in $3.1 billion deal, Taking lessons from COVID, Minnesota researchers will help develop response plan for next pandemic, HHS pledges to keep Paxlovid available as it transitions to commercial market, and FDA launches Digital Health Advisory Committee to address cross-cutting issues.

Podcasts:

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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Overcoming the Challenges of Scaling Stem Cell Cultures for Allogeneic Therapies

In this Ask the Expert session, we spoke with Whitney Wilson and Antonio Fernandez-Perez, both Field Application Scientists with Corning Life Sciences, about the incredible potential of allogeneic therapeutics, ways to solve the current challenges they face, and what the future may hold…

Accelerating the Cell and Gene Therapy Journey with Plug-and-Play Viral Vector Production Platforms

The demand for high-quality clinical-grade viral vectors has reached an all-time high, presenting a significant challenge for companies aiming to accelerate the development and potential commercialization of their cell and gene therapy (CGT) candidates. With the expanding range of approved therapies and their applications broadening beyond ultra-rare diseases, there is an urgent need for viral vector manufacturing technologies to evolve rapidly. Implementing scale-down models to develop and refine production methods that are predictive of conditions at a larger scale effectively reduce the financial burden of development, making it more accessible for developers. The current lack of standardized manufacturing procedures for lentivirus (LVV) and adeno-associated virus (AAV) vectors, commonly used in ex-vivo and in-vivo gene therapies, results in complexities and delays in achieving good manufacturing practice (GMP) compliance for crucial clinical trials…

Corning® Matrices and Cultureware Solutions for 3D Cell Culture

While traditional two-dimensional (2D) cell culture has been foundational for in vitro studies, researchers are finding that culturing cells in 3D can better replicate the in vivo microenvironment of tissues and organs, providing a more accurate view of cellular behavior within the body. 3D cell models are increasingly being integrated into research and drug discovery pipelines to bridge the gap between traditional 2D cell cultures and in vivo systems. These models serve as physiologically relevant platforms for more accurate drug screening, target discovery, and personalized medicine approaches…

The Unique Challenges of Lipid Nanoparticle Development and Manufacturing

The use of lipid nanoparticles (LNPs) as non-viral delivery tools for messenger RNA (mRNA) helps alleviate the otherwise poor pharmacokinetics (PK) and in vivo instability of mRNA. However, LNP formulation development and manufacturing remains complex and challenging. LNPs directly impact the efficacy and safety of the drug and as such, improvements to the formulation during clinical trials require significant time and human studies. Large scale CGMP manufacturing is also difficult and requires improvements to standardization, scalability, and reproducibility as the industry expands use of mRNA technology to multiple therapeutic applications. In the following interview, Jingtao Zhang, Ph.D., Scientific Director at Catalent Biologics, answered some frequently asked questions about the challenges with lipid nanoparticle development and manufacturing…

f(x) Columns for Mechanistic Chromatography Modeling

Mechanistic modeling is an approach that uses computer simulations based on known physiochemical phenomena to understand and describe a variety of chromatographic modes. These simulations can effectively decrease the number of physical experiments that need to be performed during downstream process development to optimize parameters that can affect chromatographic performance. Advantages of mechanistic modeling include time savings, improved process understanding and robustness, and support of regulatory decision making…

ÄKTA ready™ Chromatography Systems from Cytiva

In the current landscape of biopharmaceuticals, single-use technologies are being increasingly incorporated into bioprocessing workflows. They offer several benefits such as enhanced manufacturing flexibility, reduced risk of contamination, and decreased downtime that can streamline process scale-up and manufacturing. These benefits align with the goals of improving efficiency, product safety, and accelerating time-to-market for novel therapeutics while being adaptable to the evolving needs of the industry…

Enhance Downstream Bioprocessing Efficiency with AKBA’s Award-Winning MOTIV™ Inline Buffer Formulation (IBF™) Systems

Buffer formulation is an essential part of downstream bioprocessing to produce safe and effective biopharmaceuticals more efficiently. Buffers are aqueous solutions with precise pH and ionic strength that can stabilize proteins, aid purification steps, as well as regulate enzymatic activity – and are essential to creating optimal conditions for various biochemical reactions. Specific buffer compositions are required throughout the downstream process, often in volumes that can reach thousands of liters…

Cytiva MabSelect™ VL protein L affinity resin

Monoclonal antibodies (mAbs) represent a rapidly growing class of therapeutics designed to target and bind to specific proteins to treat a variety of diseases, including cancer, autoimmune disorders, and infectious diseases. They can be custom engineered to have specific properties that suit specific therapeutic needs, such as increased potency, longer half-life in the body, or reduced immunogenicity. As the field continues to advance, the molecular diversity of mAbs is increasing rapidly, where non-traditional mAb formats such as bispecific antibodies, fragments, and antibody-drug conjugates now account for up to a quarter of projects in the clinical pipeline. Conventional purification protocols relying on protein A may not always be suitable for these novel antibody variants since they may require new ligands or base matrices for effective capture of target molecule and separation of impurities. Therefore, the development of chromatography resins that can accommodate these variants is crucial for manufacturing and process development in the evolving landscape of mAb therapeutics…

Cool Tool – GoSilico™ Chromatography Modeling Software from Cytiva

Biopharmaceutical manufacturers are continuously striving to find efficiencies and make improvements across downstream processing steps to improve product quality, reduce costs, and accelerate the development of safe and effective biopharmaceuticals. Chromatography plays a critical role in the purification of biopharmaceutical products. However, developing chromatography processes can be a challenging task because it involves balancing factors such as selectivity, yield, and productivity while maintaining the purity and quality of the final product. Strategies for process development are evolving and include design of experiments (DoE) and high throughput process development (HTPD). These strategies accelerate process development and increase process understanding, but they require multiple experiments and extensive data analysis, which can be time consuming and resource intensive…

Simplified, Closed Slurry Preparation to Manage a Wide Range of Chromatography Media for DAC LC Columns

Slurry preparation is a critical step in preparing a well-packed column and achieving a successful bioprocess purification. However, this step can be challenging as different therapeutics require different chromatography media to achieve effective chromatographic separation. For instance, therapeutics in the 5 to 15 kDa range, such as insulins and oligonucleotides utilize rigid and spherical chromatography, which can be more difficult to work with. These media are based on a wide range of matrices including silica gel, polystyrene-divinylbenzene, polymethacrylate, agarose and hydroxyapatite, each with its own packing properties. As these processes are scaled up to larger column diameters, packing media becomes more complex and more crucial for success…

Webinar:

Did you know that heavy metal impurities can reduce cell culture density by up to 17 times? Nobody wants that.

Introducing the Cytiva Targeted Cell Culture Media Manufacturing™ program. It’s designed to enhance the quality of cell culture media and remove heavy metal impurities. With this program we’ve mastered the art of consistently predicting and manufacturing cell culture media within an optimized specification range—without changing your formulations. Let us help you achieve better results with our innovative approach to media manufacturing.

Learn how you can benefit from Cytiva Targeted Cell Culture Media Manufacturing program

Date: October 25, 2023

Time: 9:00 AM EDT/6:00 AM PDT

Presenter: Christopher J. Woolstenhulme, PhD Chemistry and Raw Materials Team Leader, Cytiva

Register here

Stem Cell Day Community Day:

Taking place on November 21st 2023, in Leiden, the Netherlands, the Stem Cell Community Day provides you the possibility to get together and expand your knowledge on everything stem cell-related.

Register now and join!

eBook:

Purification of antibody therapeutics – DOWNLOAD EBOOK

Approach for diversified pipeline of multispecific antibodies and antibody fragments

Antibody therapeutics are the largest class of biotherapeutics, and their development has been ongoing for decades. Over the years, development beyond traditional monoclonal antibodies (mAb) has increased, like multispecific and bispecific antibodies, antibody fragments, and antibody drug conjugates.

Manufacturing platform approaches conveniently used for many traditional mAbs are being adopted or tweaked to fit the respective molecule.

In the eBook Purification of antibody therapeutics, you will learn about considerations and tips for developing purification protocols for antibody variants.

Download eBook

eLearning Opportunity:

DESIGN OF EXPERIMENTS (DOE) FOR CHROMATOGRAPHY – TakE FREE E-LEARNING COURSES

Improve process development efficiency compared to studying one factor at a time (OFAT)

A Design of Experiments (DoE) model can be used to understand how experimental parameters affect outcomes. In chromatography process development, a DoE approach can greatly improve the efficiency in screening for suitable experimental conditions, in optimizing a process, or in robustness testing.

What is DoE?

Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows you to use a minimum number of experiments. You systematically vary several experimental parameters simultaneously to obtain sufficient information to create a mathematical model of the chromatography process.

Take one of the DoE eLearning courses from Cytiva

Explore the basic concepts of DoE, learn about the typical workflow, and get guidance on graph interpretation in the first course. Then see how to perform a DoE screening with UNICORN™ software to optimize conditions for high yield and protein purity.

• Take free eLearning “Get to know DoE”
• Take free eLearning “DoE using UNICORN™ software”

Headlines:

“How is the Inflation Reduction Act affecting biotech investment?,” Bio News

The law on every company’s and investor’s mind: the Inflation Reduction Act (IRA), which allows the government to set the prices of certain drugs. The final day of the 2023 Biotechnology Innovation Organization (BIO) Investor Forum began with a conversation about the outlook for the law and its impact on investment decisions. Regardless of whether the law stands, is amended, or goes away entirely, companies need to strategize their next steps…

“EU regulator backs use of Merck’s viral infection drug,” Reuters

Merck & Co (MRK.N) said on Tuesday the European Union medicines regulator recommended a marketing authorisation for the company’s drug Prevymis to prevent a type of infection in adult kidney transplant recipients at high risk. The drugmaker says Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) also recommended the approval for extending dosing of the drug to 200 days from 100 days, following a type of transplant in adult patients…

“Thermo Fisher Scientific to buy Olink in $3.1 billion deal,” Reuters

Thermo Fisher Scientific (TMO.N) would acquire Olink Holding AB (OLK.O) in a deal valued at $3.1 billion, the companies said on Tuesday, as the U.S. medical equipment maker seeks to boost its life sciences portfolio that helps drug discovery. The deal lifted Olink’s U.S.-listed shares nearly 67% in early trading, while shares of Thermo Fisher were down over 1%. Thermo Fisher has been struggling with softening demand for its life sciences offerings, which includes discovery and production of new drugs and vaccines, as its biotech clients face a funding crunch…

“Taking lessons from COVID, Minnesota researchers will help develop response plan for next pandemic,” Minnesota Public Radio

The University of Minnesota and the Minnesota Department of Health have been awarded $17.5 million to help develop a national outbreak response network alongside the CDC. Two of the three co-principal investigators working on the project talked with MPR News host Cathy Wurzer…

“HHS pledges to keep Paxlovid available as it transitions to commercial market,” The Hill

The Department of Health and Human Services (HHS) announced on Friday it had reached an agreement with Pfizer to ensure continued access to the antiviral Paxlovid for the next few years as it prepares to transition the drug into the commercial market. HHS said the agreement “maximizes taxpayer investment.”…