This week’s headlines include: Drug developers take fresh aim at ‘guided-missile’ cancer drugs, It was back to earth for new drug approvals in 2019, Novo Nordisk to offer free insulin to U.S. patients in immediate need, StemBioSys acquires a majority stake in Cartox, Merck’s Keytruda wins U.S. FDA approval for bladder cancer, and FDA: 2019 Continues Uptick in Orphan Drug Approvals.

Podcasts:

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Trainings:

Continuous DSP

This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.

Location: Biofactory Competence Center in Fribourg, Switzerland

January 28-30, 2020

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

Automated, high-throughput solution for cell counting, concentration and viability

There have been many improvements in the area of cell counting and several instruments have been developed to move away from time-consuming manual cell counting. However, even with automated devices, the lack of throughput for cell concentration and viability measurements can create a process bottleneck, particularly at large-scale or industrial manufacturing. In addition, this lack of high-throughput can limit experimental design or create resource demand that isn’t feasible when large numbers of samples need to be analyzed…

Optimizing Characterization and Quantification of Therapeutic Oligonucleotides

Oligonucleotides (OGN) are a class of therapeutics comprised of short strings of synthetic nucleotides. OGNs have the ability to to alter, suppress or restore expression of target genes associated with disease or health. This makes them uniquely positioned to provide treatment for diseases with a known genetic component. There are currently more than 80 companies currently investigating OGNs to treat diseases and it is a therapeutic modality that is growing dramatically…

Intelligent Lentivirus Analysis – Coupling an Automated Imaging System with Artificial Intelligence

The number of gene and cell therapies in the clinic is increasing rapidly. With the increase in gene therapy manufacturing, comes the need for improved analytics during the production process. Analytics for Lentivirus production is particularly important as it is currently the second most common vector used in cell and gene therapy manufacturing…

New Technologies to Facilitate 3D Bioprinting of Transplantable Organs

Broadly, the term “3D printing” refers to processes where a computer model of an object is recreated using materials are deposited and fused (such as polymer liquid or powder granules solidified together), layer by layer, to create a three-dimensional object. It is not surprising that this simple premise sparked innovation in other fields such as biomedical research. In this iteration, known as 3D bio-printing, living cells are deposited layer by layer in combination with biological scaffolds to form a desired 3D organic structure. While the spirit is the same as conventional 3D printing, bio-printing is considerably more complex because the functionality of tissues and organs is not solely based on physical structure. There are key interactions with other cells as well as their microenvironment, which inform their tissue-specific role. Nevertheless, this technique can be leveraged to fabricate complex, functional, cellular structures for many applications, including basic research, personalized medicine (disease modeling), regenerative medicine (transplantation or prosthetics) therapeutic investigation (drug screening/development) and for use in bioassays (cosmetics testing)…

Cool Tool – New BenchStable™ Media Provides Flexibility and Convenience While Helping the Planet

Researchers looking for reduced cold storage space requirements and easier access to media on their bench top, now have an answer. Recently launched Gibco™ BenchStable™ media are specifically engineered for room-temperature storage. This permits flexible media storage on the lab bench, thus freeing up valuable cold storage space…

Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L

Ever since the licensing of first monoclonal antibody (mAb) drug, biologics have seen unprecedented growth as drugs to treat a variety of malignancies¹. The modular structure of mAbs have allowed protein engineers to create smaller, nimbler, and multispecific next-generation antibody therapeutics. Some of these modalities can be easily produced using microbial expression systems, offering higher yields and excellent process economy²…

Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture

To ensure a safe and continuous supply of life-saving biopharmaceuticals, raw materials for biomanufacturing must be selected carefully and suppliers evaluated with much scrutiny. Several instances of drug shortages as the result of either a raw material shortage or contamination reinforce the need for thorough evaluation. Ensuring a reliable supply and the quality of the materials selected is of paramount importance…

Bioburden Control Strategies for Continuous Downstream Processing

Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process. While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing…

Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process

Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include a Protein A based affinity chromatography step followed by polishing steps. The purpose of the affinity chromatography is to capture the mAb, while the polishing steps remove any remaining impurities, such as residual DNA, host cell proteins, viruses and aggregates. There are options in the selected polishing steps, but often they involve cation exchange or hydrophobic interaction. Increasingly membrane chromatography is being used as a polishing step to remove any remaining contaminants…

Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach

Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…

Headlines:

“Drug developers take fresh aim at ‘guided-missile’ cancer drugs,” Reuters

“Dozens of drugmakers are conducting human trials for a record 89 therapies that pair antibodies with toxic agents to fight cancer, evidence of renewed confidence in an approach that has long fallen short of its promise, an analysis compiled for Reuters shows…”

“It was back to earth for new drug approvals in 2019,” Chemical & Engineering News

“After a record-shattering 2018, new drug approvals came back down to earth in 2019. The US Food and Drug Administration gave the green light to 48 new medicines last year—a slide from the 59 new molecular entities approved in 2018 but higher than the industry’s average productivity over the past decade…”

“Novo Nordisk to offer free insulin to U.S. patients in immediate need,” Reuters

“Novo Nordisk said on Thursday it would offer free, one-time supply of insulin to people in immediate need and at risk of rationing the medication, the rising price of which has attracted fierce criticism from lawmakers and regulators. Novo said patients with prescription can get a free, one-time supply of up to three vials or two packs of pens of its insulin, after which they should find a longer-term solution from its other affordability offerings…”

“StemBioSys acquires a majority stake in Cartox,” Press Release

StemBioSys, Inc. (StemBioSys) and CarTox, Inc. (Cartox) are pleased to announce that StemBioSys has acquired a majority stake in Cartox. StemBioSys will acquire all remaining equity of Cartox subject to the achievement of certain milestones. Cartox has developed an innovative approach to test cardiac safety of new drugs before those drugs are given to human patients in clinical trial programs. The Cartox technology was initially developed at the University of Michigan by Drs. Todd Herron and José Jalife who formed a company (Cartox) to further develop and commercialize this novel technology. StemBioSys believes that this technology holds significant commercial promise for applications in both pre-clinical cardiotoxicity testing as well as the potential to revolutionize the cardiac drug efficacy screening process.

“Merck’s Keytruda wins U.S. FDA approval for bladder cancer,” Reuters

“The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co Inc’s Keytruda for a hard-to-treat form of bladder cancer, making it the first new treatment for the cancer in more than two decades. The therapy was approved for patients with a high-risk, non-muscle-invasive bladder cancer who have undergone prior treatment and are ineligible for or have opted out of surgical removal of the bladder…”

“FDA: 2019 Continues Uptick in Orphan Drug Approvals,” Regulatory Focus

“Similar to 2017 and 2018, the US Food and Drug Administration (FDA) in 2019 approved an increasing number of orphan drugs and biologics, as well as drugs targeted at specific cancers. Sponsors have continued to target the development of pricier orphan treatments and the Center for Drug Evaluation and Research (CDER) reported approving more than twice as many orphan drugs in the past eight years as in the previous eight years (see graph below). In addition, more than one-third of CDER’s novel drug approvals in 2019 were cancer treatments…”