This week’s headlines include: BIO CEO Rachel King Outlines Industry’s Challenges on “Close to the Edge, Extragel: a new highly effective growth matrix, BIO submits comments on IRA’s Medicare Drug Price Negotiation Program, Bispecific CAR-T induces durable responses in advanced non-Hodgkin lymphoma, How small vaccine stockpiles can stop outbreaks of infectious disease from becoming big, and BLA Submitted for Lovo-cel, a One-Time Gene Therapy for Sickle Cell Disease.

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

Cellvento^® 4HEK Medium Provides a Comprehensive Media Solution for all Scales of AAV Production

Streamlining the adeno-associated virus (AAV) production process is a top priority for gene therapy development, as there are still issues that limit consistency and productivity. When looking at the AAV production process using human embryonic kidney (HEK) 293 cells, cell culture media has been a challenge. Specifically, there are a limited number of serum-free media that are specifically designed for AAV production at all scales, and this impacts the production consistency. To further complicate matters, there are a variety of commercially available HEK293 cell lines used and each have unique properties and different nutritional requirements, which make it difficult and time consuming to find a medium to support each cell line. In addition, because of the lack of a stable production cell line, plasmids are used for transient transfection, which means a transfection friendly media is important. Lastly, high AAV titer is needed due to large dose requirements, this means that a successful medium must be extensively optimized to each cell line to ensure high productivity…

GenScript’s Protein Molecular Weight Calculator – A Reliable and Easy-to-Use Tool for Accurate Molecular Weight Determination

Peptide molecular weight calculators are important because they provide a quick and easy way to determine the molecular weight of a peptide. Peptides are short chains of amino acids joined together by peptide bonds with a wide range of applications in various fields of research, including biology, medicine, and peptide chemistry. Accurately determining the molecular weight of peptides is essential for many research and development applications, such as peptide synthesis, protein purification, and drug development. For example, in peptide synthesis, knowing the molecular weight of a peptide is essential to determine the appropriate amount of starting materials required for the synthesis reaction…

Automating Osmolality Monitoring in Upstream and Downstream Bioprocessing

Osmolality, the concentration of a solute in a given solvent, is a frequently monitored critical quality attribute (CQA) in bioprocessing. The need to test osmolality is present throughout upstream and downstream bioprocessing. However, many current methods for monitoring osmolality are inefficient and not geared to support high throughput. Developers are increasingly looking to make critical product decisions earlier in process development. This requires testing more conditions in a shorter timeline and making the results quickly and easily accessible. For companies to have the confidence needed to make these decisions, the data generated in testing must be accurate and have low variability. The increase in testing and data generation has resulted in bioprocessing incorporating more high-throughput and automation solutions. Thus far there has not been an osmolality monitoring solution that can support this level of high throughput with accurate, precise results…

GenScript Real-time PCR (TaqMan) Primer and Probes Design Tool

Real-time PCR is a powerful molecular biology technique used in various fields that enables the quantification and amplification of specific nucleic acid sequences in real-time. The TaqMan assay is a popular real-time PCR method that employs fluorescent probes to detect and quantify DNA or RNA targets in samples that contain only a few copies, making it valuable in applications ranging from clinical diagnostics to genetic research. The PCR reaction relies on oligonucleotide probes designed to hybridize specifically to the target sequence and are composed of a fluorescent reporter dye and a quencher dye at the 5′ and 3′ ends, respectively. The primers flanking the target sequence serve as the starting point for the Taq polymerase for synthesis of the template…

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…

Advanced Single Use Scalable Chromatography System – Delivers 2 Flow Path Sizes in 1 Skid

The need for flexibility in bioprocessing is well documented. Changes in demand, multi-product facilities, and technology advancements are just some of the reasons bioprocessing volumes may increase or decrease. Since, it is not time or cost effective to procure, configure, and qualify new equipment to meet changing requirements, equipment that supports process flexibility is advantageous…

New Technology Solutions for Lentiviral Vector Clarification

The growth of the cell and gene therapy sector, and the growing number of gene and gene-modified cell therapies entering the market has translated into an increased global demand for lentiviral vectors (LVs) as a gene delivery tool. There are currently two FDA approved LV-based cell and gene therapy products—Kymriah® (Novartis) and ZYNTHEGLO® (bluebird bio), and according to the Alliance for Regenerative Medicine, an estimated 48% of the ongoing cell and gene therapy clinical trials use lentiviral vectors, with a significant number in late-stage evaluation. The strong pipeline of LV-mediated gene and CAR-T cell therapy products headed towards market approval means the development of efficient LV vector purification methods to improve yield and recovery is needed to meet the growing demand while also driving down the cost of production…

Future Proofing Downstream Bioprocess Operations

Historically, downstream bioprocesses have been simpler than upstream bioprocesses. They were more manual and Protein A columns permitted a simple and effective purification solution for monoclonal antibodies and protein-based therapeutics. More recently, upstream bioprocesses have undergone significant improvements in process and subsequently yield. These improvements in upstream created bottlenecks in downstream as the systems in place were not prepared to adjust to changes in both the starting material from upstream and yield. As a result, downstream bioprocesses have had to evolve to meet the needs of these new challenges by incorporating technology advancements such as single-use technologies, improved chromatography solutions, continuous processing, advanced buffer management systems, increased automation, and many others…

Webinar:

Anti-Idiotypic Antibody Platforms for Accelerating Antibody Drug Discovery

18 MAY 2023 10:00 AM EDT | 7:00 AM PDT

Speaker: Dr. Hui Foon Tan, PhD, Sr. Global Product Manager – Antibody, GenScript Biotech

Antibody drug discovery (ADD), starting from target identification & generation, lead validation & optimizations, preclinical candidate selection to clinical phases, is an arduous and challenging process. Advanced antibody discovery platforms and innovative techniques for antibody functional screening contribute to accelerating and improving the success rates in current therapeutics development. Once the drug candidate is identified, stringent efficacy and safety evaluations are essential from preclinical to clinical stage. Anti-idiotypic antibodies (Anti-ID Abs) are capable of binding to antibody drugs within biological fluids, therefore they are commonly used to validate drug efficacy through pharmacokinetics (PK) and pharmacodynamics (PD) kinetic assays and also used to evaluate drug safety by measuring the antibody drug immunogenicity through anti-drug antibody (ADA) assays.

In this webinar you will learn:

• Overview of anti-ID Ab in ADD.
• Overcoming the timeline challenges in ADD with GenScript’s anti-ID ab platforms.
• Elaborate on capabilities through many success case studies in current popular therapeutics such as antibody drug conjugates, scFv, VHH, bi-specific antibody and etc.
• Strategies and advantages of ADA and PK ELISA kits development.

Join on May 18th 2023 to learn more about Anti-Idiotypic Antibody Platforms for Accelerating Antibody Drug Discovery

Headlines:

“BIO CEO Rachel King Outlines Industry’s Challenges on “Close to the Edge” Genetic Engineering News

Rachel King is a trailblazer in biotech, a venture capitalist turned co-founder and CEO, now turned industry leader. As CEO of the Biotechnology Innovation Organization (BIO), King has focused in recent months on stabilizing the leadership and direction of the 1,000-plus member industry group, where the long tenure of Jim Greenwood was followed by the relatively short tenure of Michelle McMurry Heath, MD—about two years, ending last October…

“Extragel: a new highly effective growth matrix,” AMSBIO Press Release

AMSBIO is pleased to announce the launch of Extragel, a like-for-like replacement for Matrigel™, Geltrex^TM and Cultrex^TM Basement Membrane Extract (BME). Available ex-stock, with overnight shipment, Extragel is a reconstituted matrix hydrogel formed by basement membrane components extracted from mouse tumor tissues which are rich in extracellular matrix proteins…

“Mpox outbreak was wake-up call for smallpox preparation, vaccine maker Bavarian Nordic says,” CNBC

The maker of the mpox vaccine is looking at ways to dramatically scale up its production capacity to prepare for a potential threat from smallpox. Bavarian Nordic CEO Paul Chaplin said the rapid spread of mpox last year was a wake-up call for the company, which is based in Denmark…

“Bispecific CAR-T induces durable responses in advanced non-Hodgkin lymphoma,” Healio

Ten of 11 patients with relapsed or refractory B-cell lymphoma achieved objective response to an investigational dual-target chimeric antigen receptor T-cell therapy, according to study results. The novel cellular therapy exhibited a manageable safety profile, with no reports of high-grade cytokine release syndrome or neurotoxicity, findings presented at American Association for Cancer Research Annual Meeting showed…