As COVID-19 swept across the world, it has impacted millions of individuals and families. During that time, the biopharmaceutical industry came together to create treatments as swiftly as possible. As of January 2022, the main types of COVID-19 vaccines to treat SARS-CoV-2 that are approved or authorized include (1):

, which use genetically engineered mRNA to teach cells how to make a protein that triggers an immune response (ex: Pfizer-BioNTech and Moderna’s COVID-19 vaccines).

 give cells genetic instructions to produce antigens, using a different, harmless virus from the one the vaccine is targeting (e.g., Johnson & Johnson’s [J&J] COVID-19 vaccine).

Telma Lery, Janssen EMEA therapeutic area lead for infectious diseases and vaccines at Johnson & Johnson, explains that the company’s COVID-19 vaccine candidate (also known as Ad26.COV2.S, Ad26COVS1, VAC31518, JNJ-78436735, or Ad26-S.PP) is a monovalent, recombinant, inactivated/non-infective adenovirus vector (similar to a cold virus), which contains a transgene that codes for the coronavirus spike (S) protein.

Other vaccines are in the works as well. Some of the COVID-19 vaccines in clinical trials include—but are not limited to—whole virus, protein subunit, and nucleic acid vaccines (RNA and DNA) as well as more mRNA and viral vector vaccines (2). Vaxart, an American biotechnology company, is developing oral recombinant vaccines, one of which is in clinical trials in the United States as a candidate to prevent COVID-19.

“‘Recombinant vaccine’ means using DNA technology to make a protein target (i.e., antigen), rather than using the native virus to make the antigen,” says Sean Tucker, chief scientific officer of Vaxart. “Most flu vaccines [are] made in eggs by growing a flu virus, deactivating it, and injecting it in a vaccine. We use a dead common cold virus to deliver the DNA encoding the antigen to the person, where the antigen is then made. Our vaccine delivers the DNA via a tablet that breaks open in the intestine. Our vaccine works because we have a molecule that tells the immune system to pay attention to the antigen that is being made.”

“Most recombinant vaccines are made in a liquid that is injected into the arm, like the Hepatitis B vaccine. Our vaccine is dried and tableted with inert ingredients; so, it can be swallowed,” Tucker explains.

J&J has worked with industry partners, governments, and health authorities since the beginning of the COVID-19 pandemic to develop a preventative COVID-19 vaccine candidate, Lery explains. But prior to the pandemic, the company researched vaccine technology, which Lery believes granted J&J a head start in the development of its COVID-19 vaccine. The vaccine technology, AdVac, is based on the development and production of adenovirus vectors (gene carriers).

“There are 57 identified distinct variations (serotypes) of adenovirus, a type of virus that causes the common cold. Adenovirus vectors (gene carriers) are genetically altered forms of an adenovirus and lack the DNA needed to replicate. So, the vaccine cannot cause a cold, and the protein it produces cannot cause harm either,” says Lery, adding that the vaccine technology makes use of adenovirus vector Ad26, specifically.

One of the differentiating factors in the development of J&J’s COVID-19 vaccine is what could be termed “multitasking efforts.” The company combined phases of early-stage trials and had its discovery and manufacturing teams conduct processes in parallel—rather than sequentially.

The process for developing an oral recombinant vaccine, on the other hand, is similar to an injectable vaccine in terms of the clinical trials and the path to approval, according to Tucker.

“We began by identifying six vaccine candidates and winnowed the list to two,” Tucker continues. “Our initial Phase I trial tested a version that made two different antigens from SARS-CoV-2, the S protein and the nucleocapsid (N) protein. That S+N candidate made very strong T cell responses and nasal antibody responses that were cross-reactive against a wide variety of coronaviruses. The current set of trials (Phase II in the US) is evaluating an S-only protein approach, which made better antibody responses in non-human primates.”

But the process of identifying and progressing to clinical trials in a pandemic wasn’t without its challenges. In early 2021, Vaxart had to compete with other biotech companies for manufacturing space. Fortunately, the company had two plants for producing pills for their clinical trials and had enough materials on hand.

Some of the main differences between a COVID-19 oral tablet vaccine from injectable COVID-19 vaccines, according to Tucker, include:

Immune responses are triggered in the mucosa and the serum with a COVID-19 oral tablet vaccine (based on preclinical and clinical testing), unlike the existing vaccines that are serum-only.

Ease of distribution and vaccination with a COVID-19 oral tablet vaccine, which eliminates the need for special accommodations to transport injectable vaccines that require cold chain infrastructure as well as the need for trained professionals to administer vaccines.

The research behind COVID-19 vaccines: antigens

Understandably, the COVID-19 vaccines weren’t created without upfront heavy lifting. One company, The Native Antigen Company, part of LGC Clinical Diagnostics, provides commercially available S1 and S2 antigens for SARS-CoV-2, which include the amino mutations associated with different variants. The company developed more than 100 antigens, antibodies, receptors, and kits for the coronavirus, which have been used by diagnostic, therapeutic, vaccine, and public health organizations to study SARS-CoV-2 and develop countermeasures against it.

Vaccine developers can use S mutant antigens to raise mutant-specific antibodies and develop assays (often enzyme-linked immunosorbent assays) to assess the efficacy of their vaccines, according to James Shore, technical product manager of The Native Antigen Company. In addition, biopharmaceutical companies use The Native Antigen Company’s reagents to develop monoclonal antibody therapies against SARS-CoV-2 and its variants. But how can S antigens be adapted to address the various variants?

“If a variant includes only a couple of point mutations, then a modification of PCR [polymerase chain reaction] amplification can be used to introduce changes to the gene sequence,” says Shore. “More commonly, however, the sequence is computationally redesigned and chemically re-synthesized.”

No matter the type, COVID-19 vaccines and treatments must address new variants and mutations of the virus in some capacity. Some of the variants include Delta, Mu, and Omicron.

“COVID-19 variants arise through mutations in the virus. Mutations may result in the virus obtaining increase in transmissibility, more severe disease, reduction in vaccine or treatment efficacy, etc.,” says Kristina Hsieh, scientific affairs lead, Clear Labs. “There are numerous real-world studies that have shown that getting vaccinated reduces one’s risk of severe illness, hospitalization, and death from the different variants. One of the articles recently published by Bajema et al. indicated a reduction in hospitalization due to vaccination from data gathered from five Veterans Affairs Medical Centers” (3–5).

Hsieh adds that the main difference, genetically, between the variants are different mutations that have accumulated throughout the virus. As the Delta variant has demonstrated, some mutations may lead to increased transmissibility and/or more serious illness. In addition, one of the new variants, Omicron, has been detected in the US.

“The CDC and its public health partners are working closely to monitor this variant,” says Hsieh. “Through Whole Genome Sequencing (WGS), public health laboratories are able to quickly identify, track, and monitor the variant.”

In addition to monitoring variants of the virus and being vigilant in the research and development of new COVID-19 vaccines and treatments, the industry needs to continue to communicate and share resources. Consistent communication and collaboration between all organizations in the biopharmaceutical industry—from governments, to agencies, to developers, to manufacturers, and everyone in between—will play a huge role in combatting the spread and impact of COVID-19.

Gavi, “There are Four Types of COVID-19 Vaccines: Here’s How They Work,” 

M. W. Tenforde et al., “Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity,” 

H. Chung et al., “Effectiveness of BNT162b2 and mRNA-1273 Covid-19 Vaccines Against Symptomatic SARS-CoV-2 Infection and Severe Covid-19 Outcomes in Ontario, Canada: Test Negative Design Study,” 

K. L. Bajema et al., Morbidity and Mortality Weekly Report, 

Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021

Articles

Features

New technologies are treatments are emerging to tackle COVID-19 and its assortment of new variants.

The Next Step For COVID-19 Vaccines

Regenerative medicines encompass a range of emerging biotherapies, the most well-known of which are cell and gene therapies. Tissue therapies are also a category of regenerative medicines. The development of regenerative medicines has sparked some of the most innovative therapeutic targets and biomolecules. However, the complex nature of these medicines makes successful commercial development quite challenging. With significant leaps in drug development technologies over the past few years, where does the market for regenerative medicines stand today?

Much of the progress that regenerative medicines have made in the past two years would not have been possible without infusion of funds, and the investment patterns seen in 2021 are expected to strongly support the long-term growth and success of this sector. In the Alliance for Regenerative Medicine’s (ARM’s) 2022 state of the industry address (1), Janet Lambert, CEO of ARM, noted that the regenerative medicines sector, specifically cell and gene therapies, had another record-breaking year of investment in 2021. In particular, the rise of gene editing continued at a strong pace, which Lambert attributed to a hefty infusion of venture capital into early-stage companies.

According to Lambert in her state-of-the-industry presentation, 2021 set another investment record for cell, gene, and tissue-derived therapies, with $23.1 billion raised over the course of that year, reflecting a 16% increase from 2020. Lambert emphasized that gene therapy developers raised the most capital in 2021 with $10.6 billion raised, followed closely by cell-based immuno-oncology (cell IO) developers, with $10.1 billion raised. “Although gene therapy out-raised cell IO, cell IO continues to show the strongest growth with 26% increase in financings year-over-year,” Lambert said in the presentation.

Meanwhile, companies active in gene editing raised a total of $8.5 billion in 2021, which accounted for more than one-third of the total amount raised sector-wide, according to Lambert. A breakdown showed that companies active in gene editing made up $4.7 billion of the financing in the gene therapy category, or approximately 45% of the total gene therapy financings in 2021, up from 38% three years ago. “Excitement in this sub-sector is driven by the in-vivo CRISPR [clustered regularly interspaced short palindromic repeats] data from Intellia [Therapeutics]as well as the continuing advances in traditional and new editing technologies,” said Lambert. Meanwhile, products derived from base editing technology is set to enter the clinic in 2022, with the approval of the first gene-edited therapy potentially occurring in 2023, she noted in her presentation.

The year 2021 was notable for new regenerative medicine product approvals. With six new products approved, 2021 was the second best year on record, following the approvals of nine new regenerative medicines in 2016, stated Lambert in her state-of-the industry address. Additionally, 2021 was a notable year for approvals of cell-based immuno-oncology, with three new chimeric antigen receptor T cell (CAR T) therapies approved across the United States, Europe, and China, including the first approval of a B cell maturation antigen (BCMA)-targeted CAR T therapy, Abecma (idecabtagene vicleucel) by Celgene, a Bristol Myers Squibb company (2). Lambert noted that this product was also the first CAR T therapy approved for treating multiple myeloma.

Furthermore, 2021 also saw notable product approvals for regenerative medicine products for treating a serious inherited neurological disorder, a rare and historically fatal birth defect, and severe burns. 2021 was a breakout year for FDA’s regenerative medicine advanced therapy (RMAT) designation (3), in which three out of the four products approved in the UShad RMAT designation. “This designation, which ARM played a leading role in creating, was established in 2016 and is intended to expedite patient access to innovative regenerative medicine therapies. To date, 67 regenerative medicine programs have been awarded RMAT designation,” said Lambert her presentation.

ARM is currently tracking 2261 active global clinical trials in regenerative medicine, including both industry-sponsored trials and academic and government-sponsored trials. Lambert presented clinical trial data in her state-of-the-industry address, which represents data from the third quarter of 2021 (end-of-year clinical data not yet reported at the time Lambert’s state-of-the-industry was given). Looking at specific indications, cancer is shown as the number one target for cell and gene therapies, with 1354 ongoing trials in cancer indications. There is also significant clinical development activity in other disease categories, namely neurological disorders, diabetes and diabetes-related disorders, cardiovascular, rare genetic disease, and stroke, according to ARM’s findings.

“Of these [2261 active global clinical trials in regenerative medicine], there are 1129 active industry-sponsored regenerative medicine trials globally,” said Lambert. Cell-based immuno-oncology makes up the largest portion of the regenerative medicine clinical trial landscape, which is primarily due to a large number of Phase I trials in immuno-oncology indications. According to data collected by ARM, cell-based immuno-oncology makes up more than half of all Phase I industry-sponsored regenerative medicine trials, which reflects a relatively recent tilt towards the immuno-oncology field. With 143 Phase III industry-sponsored trials currently underway, 44% are in cell therapy, 33% are in gene therapy, and 22% are in immuno-oncology, according to ARM.

“We’re also tracking 1100 academic and government-sponsored trials worldwide, about the same number as industry trials. As a whole, these trials, not surprisingly, tend to be earlier stage with a significantly different technology mix. In academia, we also see a much larger proportion of cell therapy trials and a much lower proportion of gene therapy trials,” explained Lambert in her address.

Based on a rich pipeline, ARM anticipates that 2022 may be a record year of approvals for new gene therapies targeting rare diseases. “It could be a really active year, with as many as 15 anticipated decisions across the US and Europe, including nine on never-before approved products,” Lambert emphasized in her state-of-the-industry address. “As of now, we’re due to have regulatory decisions on five new products across the US and Europe from BioMarin Pharmaceutical, Gencyte Therapeutics, PTC Therapeutics, uniQure and CSL Behring, and Crystal-Bio. We will very likely see a record number of approvals for this product class in 2022.”

Looking at the clinical pipeline for regenerative medicines beyond 2022, Lambert expects that the industry will gradually see an evolution from rare monogenic diseases and liquid tumors to more prevalent diseases and solid tumor cancers. “We have many late-stage programs in a variety of cancers. Importantly, the first gene therapy for a prevalent disease could be just a few years out. The oft quoted 2019 FDA prediction of 10–20 approvals by the year 2025 still looks doable, albeit likely at the lower end of that range. This is something [FDA] has recently reinforced in conversations with us,” Lambert stated in her presentation.

1. ARM, “Cell & Gene State of the Industry Briefing,” 

, Jan. 10, 2022.
2. FDA, “FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma,” Press Release, Mar. 27, 2021.
3. FDA, “Regenerative Medicine Advanced Therapy Designation,” 

Feliza Mirasol is the science editor for 

A rise in investments and funding into regenerative medicines projects has helped to advance a rich clinical pipeline. 

Regenerative Medicines Development Activity Spikes on Back of Focused Investments

McGill University announced on Feb. 15, 2022 that university researchers used the Canadian Light Source (CLS) at the University of Saskatchewan to advance a novel method for growing synthetic bone tissue. The breakthrough comes after more than 30 years of the scientific community’s work on developing a synthetic alternative to bone grafts for repairing diseased or damaged bone.

Bone tissue engineering, a rapidly growing field, is focused on growing bone cells in the lab on scaffolds, then transferring these structures into a person’s body to repair bone damage. Like the bone it mimics, the scaffolds need an interconnected network of small and large pores that allow cells and nutrients to spread and help generate new bone tissue.

The McGill research team developed a way to modify the internal structure of a material, known as graphene oxide, to make the material more conducive to regenerating bone tissue. Graphene oxide is an ultrathin, extra-strong compound increasingly used in electronics, optics, chemistry, energy storage, and biology. Because of the material’s unique properties, stem cells tend to transform into bone-generating osteoblasts when placed on the graphene oxide.

The research team is a multidisciplinary group, comprising researchers from McGill’s Departments of Mining and Materials Engineering, Electrical Engineering, and Dentistry. The team found that adding an emulsion of oil and water to the graphene oxide, then freezing it at two different temperatures, yielded two different sizes of pores throughout the material.

When the now-porous scaffolding was “seeded” with stem cells from mouse bone marrow, the cells multiplied and spread inside the network of pores, which is a promising sign that the new approach could eventually be used to regenerate bone tissue in humans.

“We showed that the scaffolds are completely biocompatible, that the cells are happy when you put them in there, and that they’re able to penetrate all through the scaffold and colonize the whole scaffold,” said Marta Cerruti, a materials engineering professor at McGill University, in a company press release.

The researchers used the BioMedical Imaging and Therapy–bend magnet beamline at the CLS to visualize the different sized pores inside the scaffolding as well as the growth and spread of the cells.

“To our knowledge, this is the first time that people have used synchrotron light to see the structure of graphene oxide scaffolds,” said lead researcher Yiwen Chen, who works under Cerruti.

Widespread clinical application of this new approach may still be many years away, but the work could enable other researchers to learn more about how stem cells morph into bone cells, according to Cerruti in the press release.

“Maybe this will lead to a better understanding of the biology of bones that we wouldn't understand otherwise,” Cerruti said in the press release. “Perhaps in the shorter term we can use the methods in the lab to better understand bone and perhaps develop new drugs.”

News

Researchers at McGill University have made advancements with a novel method for growing synthetic bone tissue.

Researchers Make Progress with New Method of Rebuilding Bone Tissue

Bio-Rad Laboratories launched a range of anti-daratumumab antibodies that are specific for daratumumab (Darzalex) in February 2022. These antibodies inhibit the binding of daratumumab to its target, CD38. Because of their high specificity and high-affinity these recombinant antibodies are suitable for bioanalysis and drug monitoring of daratumumab and its biosimilars.

Bio-Rad’s portfolio of antibodies are generated using the Human Combinatorial Antibody Libraries and CysDisplay, a proprietary method of phage display, along with guided selection methods to obtain highly targeted reagents, according to the company in a Feb. 14, 2022 press release. The anti-daratumumab antibodies are approved for 

 research purposes and for commercial applications providing 

testing services to support preclinical and clinical drug development.

Daratumumab, an anticancer drug that binds to the CD38 protein that is overexpressed in multiple myeloma cells, leads to immune-mediated apoptosis of the tumor cell. The new range of anti-daratumumab antibodies comprises three fully human immunoglobulin G1 inhibitory antibodies that have varying levels of affinity. The antibodies can be used as surrogate positive controls in anti-drug antibody assays as well as for the development of pharmacokinetic bridging enzyme-linked immunoassays to measure free drug.

“We are pleased to continue the expansion of our range of anti-idiotypic antibodies to support researchers developing novel treatments,” said Amanda Turner, Bio-Rad product manager, Life Science Group, in the press release. “Our recombinant production methods result in batch-to-batch consistency, so researchers can rely on our antibodies to deliver reproducible results over the lifecycle of their bioanalytical assays.”

New Technology

Bio-Rad has launched a range of antibodies specifically for daratumumab that inhibit the binding of the drug to the target antigen, CD38, which allows for highly specific bioanalysis and drug monitoring.

Bio-Rad Offers a Range of Anti-Daratumumab Antibodies Specific for Daratumumab

New England Biolabs (NEB) announced the release of its Luna Probe One-Step RT-quantitative polymerase chain reaction (qPCR) Mix with uracil-DNA glycosylase (UDG) in February 2022. The lyophilized master mix is designed to enable sensitive, linear, real-time detection of target RNA sequences in a room temperature-stable format.

The LyoPrime Luna is the first lyophilized product manufactured by Fluorogenics since NEB purchased the company in 2021, according to a Feb. 9, 2022 press release. The product contains murine RNase inhibitor, deoxynucleoside triphosphate, and a passive reference dye. It incorporates thermolabile UDG, which is well-suited to RNA workflows, as well as deoxyuridine triphosphate to reduce carryover contamination risk between reactions.

"The launch of LyoPrime Luna Probe One-Step RT-qPCR Mix will showcase the first of many NEB lyophilized products that we hope will change the market's perception of ambient, stable molecular reagents," said Martin Lee, managing director of Fluorogenics, in the company press release. "Customers everywhere will benefit from state-of-the-art real-time PCR performance in a more flexible format that additionally reduces the environmental impact of cold shipment and storage."

When measured in NEB’s “dot in boxes” scoring method—a high-throughput data visualization tool that provides quality scores for qPCR outcomes—the LyoPrime Luna outperformed many competitor products and strongly matched the company’s liquid mix, according to the press release.

"The current worldwide focus on infectious diseases has highlighted the need for increased access to robust RNA reagents in a variety of formats,” said Nicole Nichols, associate director of applications and product development, NEB, in the press release. “By lyophilizing our Luna WarmStart RT-based product, we've achieved a one-step RT-qPCR mix that provides the same high level of performance delivered by our liquid master mix. As a standard catalog offering, this will lower barriers to a high-quality lyophilized reagent and simplify the RT-qPCR assay development process.”

The Luna Probe One-Step RT-qPCR Mix with UDG is designed to enable sensitive, linear, real-time detection of target RNA sequences.

New England Biolabs Releases Lyophilized Master Mix

Element Biosciences, a biotechnology company, announced on March 1, 2022 that it has entered into an agreement with Genoox, a community-driven genomic data platform, to validate the clinical potential of its AVITI system. AVITI is Element’s new DNA sequencing platform that is designed to perform whole-genome sequencing in research concerning rare and undiagnosed diseases.

According to a company press release, while the use of sequencing data in clinical research has grown at a “staggering rate”, the density of data in genome-wide approaches has resulted in an interpretation bottleneck. The bottleneck can be circumnavigated by tools such as those developed by Genoox, as these tools can rapidly identify small sets of variants most likely to cause the phenotype of the patients.

An initial study using the AVITI platform sequenced the data of ten individuals with a rare eye disease. In five of these cases, high confidence candidate variants were identified by Genoox’s interpretation platform Franklin. Should these results be clinically validated, the anticipated diagnostic yield of the study will be 50%.

“We are pleased to partner with Genoox,” said Molly He, CEO and co-founder of Element, in the press release. “Our initial study demonstrated how effectively the joint offering works for whole genome sequencing and variant interpretation.”

“The accuracy of the sequencing data that is being produced by Element Biosciences and its AVITI system has the power to unlock the value of whole-genome sequencing and create lasting impacts for the genomics industry,” said Amir Trabelsi, CEO and co-founder of Genoox, in the press release. “Combining the technologies of Element and Genoox enables actionable insights to be drawn from that data.”

Genoox will use their genomic data platform to validate Element's AVITI system.

Element Biosciences Partners with Genoox on Validation Project

On March 1, 2022, Thermo Fisher Scientific and Symphogen, an affiliate of and the antibody center of excellence within pharmaceutical company Servier, announced the continuation of a collaboration under which the companies are providing biopharmaceutical discovery and development laboratories with innovative tools and streamlined workflows for efficient characterization of complex therapeutic proteins.

Under the initial collaboration, started in 2018, Symphogen adopted new and innovative instruments and software that improves data quality and processes. The implementation of these instruments and software enhanced the ability to develop, test, and routinely implement platform workflows for intact and native mass analysis of therapeutic monoclonal antibody mixtures. More recently, the implementation of the Thermo Scientific Orbitrap Exploris MX Mass Detector allows for a high level of data confidence and an efficient workflow by conferring seamless method transfer from development instruments, according to a company press release.

The new system adds to Symphogen’s range of high-resolution accurate mass mass spectrometry technologies, including the Thermo Scientific Q Exactive Plus Orbitrap liquid chromatography–tandem mass spectrometry system and the Thermo Scientific Orbitrap Exploris 240 and 480 mass spectrometers. These systems will be controlled with the Thermo Scientific Chromeleon chromatography data system software, which allows for secure, remote operations and data processing from any location in the world. The ability to have remote operations provides working flexibility and improved data protection.

“The extension of our collaborative relationship with Symphogen demonstrates our continued commitment to solve tangible scientific challenges within the biopharmaceutical industry,” said Eric Grumbach, director biopharma, pharma business, chromatography and mass spectrometry, Thermo Fisher, in a company press release. “Further investment in this collaboration enables critical insights that feed directly into the development of new analytical tools, providing meaningful impact to the characterization of complex biotherapeutics.”

“Mass spectrometry is playing an increasingly important role in biopharmaceutical development at Symphogen, as exemplified in 2021, when we analyzed over 10,000 biopharmaceutical samples by intact mass analysis on our Orbitrap mass spectrometers. A multitude of separation techniques are now routinely hyphenated to our mass spectrometers, providing unrivalled insight into product quality, from early discovery to late-stage clinical development,” said Dan Bach Kristensen, principal investigator, Symphogen, in the press release.

Thermo Fisher and Symphogen have extended their collaboration involving improved data workflow, which supports the discovery and development of new cancer treatments.

Thermo Fisher Scientific Extends Collaboration Support for Biopharma Discovery and Development

A new collection of caps, vials, inserts, kits, well plates, and mats from Thermo Fisher Scientific is intended to improve analytical performance and sample security for chromatography and mass spectrometry users in routine and research laboratories. The new consumables are applicable in both the pharma and biopharma sectors as well as across the clinical, food, environmental, and academia sectors.

Launched under the Thermo Scientific SureSTART portfolio in February 2022, the new consumables are compatible with all add-on and chromatography autosamplers, allowing analysts to use the new portfolio regardless of instrument vendor, according to a Feb. 21, 2022, company press release. The new collection provides sample security and low compound adsorption, even for challenging, low-level analytes, which provides laboratories with confidence in results and reduces the time needed for reviewing background peaks or identifying analytes that have shifted retention times.

The SureSTART product line draws from existing products that have been historically successful in the market. The collection aims to provide precise and consistent measurements between different vials and different lots.

“As a trusted provider of vials, closures, and well plates, we continue to innovate to offer laboratories the improved flexibility and assurance needed to meet analytical requirements,” said Detlev Lennartz, product manager, sample handling, chromatography and mass spectrometry, Thermo Fisher, in the press release. “SureSTART consumables are built from high-quality materials that meet both the performance and price requirements of our customers, providing the confidence they need to analyze challenging analytes. Additionally, the new collection is fully compatible with GC [gas chromatography], GC–MS [gas chromatography mass spectrometry], LC [liquid chromatography] and LC–MS [liquid chromatography mass spectrometry] analytical instruments and includes three performance levels to help laboratories choose the right product for their experimental needs.”

A new portfolio of chromatography and mass spectrometry consumables launched by Thermo Fisher Scientific is designed to meet higher performance requirements while remaining economical.

Thermo Fisher Scientific Introduces New Portfolio of Chromatography and Mass Spectrometry Consumables

FDA’s Center for Drug Evaluation and Research announced a new virtual workshop slated to happen on March 23–24, 2022. The public meeting, “Identification of Concepts and Terminology for Multi-Component Biomarkers,” will be held to discuss high-level terminology surrounding biomarkers.

According to an FDA press release, the goal of the symposium is to develop multi-component biomarker concepts and terminology, identify areas of conceptual language development, and discuss gaps in terminology for concepts and approaches as it relates to multi-component biomarkers.

The symposium will be held via live webcast for the public from 1:00–3:00 pm ET on both days. A full breakdown of the events schedule can be found 

. The public will also gain access to additional pre-recorded talks three weeks prior to the live event, which FDA recommends viewing ahead of the event.

FDA will hold a symposium discussing the identification of concepts and terminology for multi-component biomarkers from March 23–24, 2022.

FDA to Hold Public Symposium on Multi-Identification Biomarkers

The European Patent Office has granted another patent to Salipro Biotech, a Swedish biotech company, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

According to a Feb. 8, 2022 press release, the “Antigen and method for production thereof” patent (No. EP 3 043 814 B1) will strengthen Salipro Biotech’s proprietary platform technologies to enable the discovery and development of next-generation therapeutics against challenging drug targets.

“We’re constantly increasing our collaborations, partnerships and licensing agreements with major pharma companies on a wide range of challenging drug targets,” said Maria Knudsen, business development director at Salipro Biotech AB, in the press release. “Expanding our already strong patent portfolio further will enable us to increase the value of such collaborations for our partners as well as moving towards building our own discovery pipeline.”

“We’re excited about this important milestone that provides additional protection for our core technologies. The market for therapeutic antibodies, vaccines and biologics is ever expanding,” added Jens Frauenfeld, CEO, Salipro Biotech, in the press release. “Securing these patents protects our innovative platform and further strengthens our position by supplementing our foundational and follow-up patents that have already been granted to Salipro Biotech in many countries, including US, [European Union], China, and Japan.”

The European Patent Office has granted another patent to Salipro Biotech,  covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

BioPharm International's BP Elements, March 2022