This compilation allows readers to adjust their thinking to appreciate the full impact certain select technologies will make on the industry by 2026.

Six Approaches Making the Most Significant Impact in the Future

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

Purification of Antibodies Using Novel Convecdiff Membranes Part 1

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

Crossing the Same River Multiple Times

Biologic drug development requires relevant bioassays to measure and help predict cellular response.

Complex Analytical Workflows Increasingly Require Robust Bioassays

Affinity chromatography resins must perform well under mild elution conditions yet withstand robust cleaning and sanitization protocols.

Choosing the Right Resins for Viral Vector Affinity Chromatography

Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.

Safeguarding Biologics— Blending Engineering Ingenuity and Managerial Excellence

Health crises, political tension, and budget concerns were major challenges.

Pandemic and Politics Shaped Pharma and FDA in 2022

Agilent and Quest Diagnostics entered into an agreement to expand access to the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test. The ctDx FIRST is a single-site premarket approved test that is approved by FDA (1) as a companion diagnostic (CDx) to identify advanced non-small lung cancer (NSCLC) patients who may benefit from treatment with adagrasib (brand name Krazati). Adagrasib is a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.

According to a Jan. 23, 2023 company press release, under the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for adagrasib. The test can be ordered online through Quest’s online connectivity platform, and healthcare providers may additionally direct patients to provide specimens at one of Quest’s 2100 patient service centers in the US.

“We are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution,” said Paul Beresford, vice-president and general manager, Companion Diagnostics Division, Agilent, in the release. “This expands the testing options available for NSCLC patients as patients don’t always have tissue available for molecular analysis.”

"The addition of the ctDx FIRST test to our oncology menu underscores our commitment to providing access to precision medicine innovations to improve care for patients with cancer," said Kristie Dolan, vice-president and general manager, Oncology Franchise, Quest Diagnostics, in the release. "It also reflects our ability to optimize our national physician and patient access network to extend access to important medical innovations with the potential to improve patient outcomes."

1. FDA, “FDA Grants Accelerated Approval to Adagrasib for KRAS G12C-Mutated NSCLC,” Press Release, Dec. 12, 2022.

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Agilent will work with Quest Diagnostics to distribute the ctDx FIRST test.

Agilent and Quest Diagnostics to Collaborate on Lung Cancer Diagnostic

Illumina, a DNA sequencing and array-based technologies provider, and Nashville Biosciences, a subsidiary of Vanderbilt University Medical Center (VUMC), have teamed up with Amgen to provide whole-genome sequencing of approximately 35,000 DNA samples. The sequencing of this sample cohort, which primarily comprises DNA from African-Americans, is intended to mitigate their underrepresentation in research for clinical applications of genomics. The sequencing will be performed by deCODE genetics, a subsidiary of Amgen.

According to a press release from Jan. 9, 2023, the sequencing of these samples is the first step in Illumina and Nashville Biosciences Alliance for Genomic Discovery (AGD) program. The agreement intends to whole-genome sequence at least 250,000 de-identified human DNA samples from VUMC’s BioBU biobank over the course of two and a half years.

"The initial cohort will be among the largest sequencing efforts involving African Americans to date," said Leeland Ekstrom, CEO, Nashville Biosciences, in the release. "Once complete, this data set will provide a wealth of new information about the human genome and accelerate the study of disease in—and discovery of new therapeutics for—populations less well represented in prior large-scale sequencing efforts. The opportunity to sequence this diverse set of samples will help broaden our understanding for individuals who have been underrepresented in genetic research and continue to experience health disparities."

"deCODE's sophisticated human data capabilities are well positioned to sequence these samples and analyze the resulting data to provide a better scientific understanding of disease through the context of human diversity," said Kári Stefánsson, founder, deCODE genetics, in the release. "Insights from human data, including both genetics and clinical records, can help inform how medicines may affect different patient populations."

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement

GeoVax announced on Jan. 25, 2023 that the United States Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, “Method for Generating a Zikv Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein.”

According to GeoVax, Zika virus (ZIKV) is linked to an increase in microcephaly in infants and neurodegenerative disease, Guillain-Barre syndrome, in adults. The claims to be granted in the patent cover GeoVax’s modified vaccinia Ankara (MVA) vector comprising a nucleic acid sequence encoding a ZZIKV nonstructural (NS1) protein, of which GEO-ZM02 is designed. The company states its MVA platform holds the potential to address the critical unmet need in vaccination of women of childbearing age and newborns against ZIKV.

“Our novel Zika vaccine candidate, GEO-ZM02, is constructed using our modified vaccinia Ankara (MVA) vector platform. Preclinical studies demonstrated a single dose of GEO-ZM02 provided 100% protection against a lethal dose of Zika virus,” stated GeoVax CEO David Dodd, in a company press release. “Addressing many of the world’s most threatening infectious diseases is part of our vision and corporate priorities for MVA’s applications, which also includes an MVA-based next-generation COVID-19 vaccine currently in Phase II clinical trials.”

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

USPTO Issues Notice of Allowance for Zika Vaccine Patent 

Eli Lilly and Company (Lilly) announced that FDA had rejected its accelerated approval application for donanemab as a treatment for early symptomatic Alzheimer's disease on Jan. 19, 2022. In its response letter, FDA cited concerns surrounding an insufficient quantity of clinical trial data.

According to a company press release, FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly cited the experimental design of the study, which allowed patients to complete their treatment once targeted deposits of amyloid plaque were reduced to predefined endpoints, as causing the insufficient quantity of data. Lilly is currently in the middle of a confirmatory Phase III clinical trial (TRAILBLAZER-ALZ 2), with topline data expected in the second quarter of 2023.

"We anticipate [TRAILBLAZER-ALZ 2] will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ Phase II study and believe that patients and physicians will be well served by having the full Phase III data available alongside our Phase II data when they need to make treatment decisions," said Anne White, executive vice-president and president, Lilly Neuroscience, Eli Lilly and Company, in the press release. "We are committed to working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need."

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

The FDA is issuing a new guidance to support sponsors in the development of drugs for monkeypox (mpox). The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

In the past, FDA has approved drugs for the treatment of smallpox under regulations commonly referred to as the Animal Rule, but this pathway is not applicable to drugs for mpox because the research team can design and implement clinical trials for mpox that are both ethical and feasible.

The FDA’s guidance documents do not establish legally enforceable responsibilities but instead describe the Agency’s current thinking on a topic and should only be viewed as recommendations.

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.



FDA Issues Guidance on Development of Drugs for Monkeypox

AmMax Bio announced on Jan. 19, 2023 that the European Medicines Agency (EMA) has granted AMB-05X Priority Medicines (PRIME) designation for the treatment of tenosynovial giant cell tumor (TGCT).

“The positive proof-of-concept data from our prior 12-week Phase II study of AMB-05X in TGCT provided the basis for our PRIME application,” said Larry Hsu, PhD, chief executive officer of AmMax Bio, in a press release. “We appreciate EMA’s decision to award AMB-05X its PRIME designation, which validates the high potential therapeutic value of the program and the significant unmet medical need for patients impacted by TGCT.”

AmMax Bio presented positive Phase II data for the novel local administration of AMB-05X in patients with TGCT at the Connective Tissue Oncology Society meeting in November 2022. The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

The PRIME designation was launched by EMA to boost support for the development of medicines that target an unmet medical need. EMA will continue to offer early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks through PRIME, according to the company press release.

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

Asimov, a synthetic biology company advancing the design and manufacture of therapeutics, announced a strategic partnership with Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) on Jan. 18, 2023.

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients. According to the press release, HEK293 cell lines are the industry standard for producing therapeutic viral vectors, which are used mainly in gene therapies.

CBM will now be available for clients to get immediate access to a high-performance clonal good manufacturing practice qualified cell line as a measure of its comprehensive capabilities for vector manufacturing designed to deliver high yields and higher throughput without comprising quality.

“Our partnership with CBM is a major step forward in our goal to advance therapeutics manufacturing,” said Alec Nielsen, CEO of Asimov, in a press release. “This validates our efforts in the viral vector space, and supports other research directions in host cell optimization, genetic system engineering, and bioreactor process modeling and development. By licensing our HEK293 viral vector production platform, CBM will be able to provide their clients with immediate access to reduce the cost of manufacturing these complex therapeutics.”

The agreement finds CDM offering its clients access to the platform as a part of its end-to-end comprehensive capabilities for vector manufacturing designed to accelerate development and manufacturing timelines of vector-based advanced therapies.

“We believe this is the initial step of many with Asimov, an industry leader in mammalian synthetic biology and cell line development,” said Avi Nandi, chief technical officer at CBM, in a press release. “We continue to make significant investments into our technology platforms to ensure our clients have access to an end-to-end solution that allows them to develop and manufacture at lower costs. Our goal is for rare disease therapies to be accessible to as many patients around the world as possible and our relationship with Asimov removes a key barrier to therapy developers.”

The partnership led to Asimov licensing its clonal GMP HEK293 suspension cell line to CBM for pre-clinical and clinical production of viral vectors for its clients. 

Asimov and Center for Breakthrough Medicines Collaborate for Viral Vector Production

On Jan. 19, 2023, Advaxis, Inc., a biotechnology company focused on the discovery, development, and commercialization of immunotherapies, completed a previously announced merger with Ayala Pharmaceuticals, Inc., a clinical-stage oncology company that develops and commercializes small molecule therapeutics for patients who have rare tumors and aggressive cancers.

The merged company will operate under the name Ayala Pharmaceuticals and will target the development and commercialization of Ayala’s lead program, AL102, for the treatment of desmoid tumors. AL102 has received Fast Track Designation from FDA and is currently in phase 3 of a trial for patients with desmoid tumors.

The merged company will operate under the name Ayala Pharmaceuticals and will target the development and commercialization of Ayala’s lead program, AL102, for the treatment of desmoid tumors. 

Advaxis, Ayala Pharmaceuticals Complete Merger

Medigene AG, an immuno-oncology company focused on the development of differentiated, T Cell Receptor engineered T cell (TCR-T) therapies, announced on Jan. 18, 2023, that it has received a $3 million payment from partner 2seventy bio as a part of its T cell receptor agreement in cancer immunotherapy, which may lead to further historical payments in the future.

This payment comes after the strategic alliance between 2seventy bio and JW Therapeutics with a focus on the development of 2seventy bio’s MAGE-A4 program, which services a highly potent TCR discovered in collaboration with Medigene’s proprietary end-to-end technology platform.

Recently, 2seventy bio announced the initiation of a strategic partnership with JW Therapeutics aiming at the collaboration being the development of 2seventy bio’s MAGE-A4 cell therapy in mainland China, Hong Kong, and Macao.

“We are delighted that Medigene’s partnership with 2seventy bio has led to the progress of cell therapies in China through 2seventy bio’s strategic alliance with JW Therapeutics,” said Selwyn Ho, PhD, chief executive officer of Medigene, in a press release. “This alliance, and recent milestone payment to Medigene, further validate our end-to-end technology platform and its potential to deliver differentiated, best-in-class TCRs. We look forward to the commencement of the MAGE A-4 TCR program in mainland China, Hong Kong, and Macao, and the benefits this could mean for patients.”

“We are excited about the ability to accelerate the development of the MAGE-A4 program; made possible in part by the important contributions of our collaboration with Medigene,” said Steve Bernstein, chief medical officer of 2seventy bio, in a press release. “This is a powerful program, supported by our collective areas of expertise and designed to create potentially transformative treatments for patients with solid tumors.”

This recent payment does not alter guidance on the cash runway of Medigene, which is based on current planning into Q4 2024.

Medigene Receives Historic $3 Million Payment from 2seventy Bio

Cambrex, a global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services, announced on Jan. 18 2023 that it has acquired Snapdragon Chemistry, a US-based provider of chemical process development services to a broad range of emerging and established biopharma customers.

“Today, we welcome our new colleagues from Snapdragon to Cambrex,” said Tom Loewald, CEO of Cambrex, in a press release. “With Snapdragon’s depth of scientific expertise in API process development, I’m certain our customers will see the benefits of this combination and be delighted to work with Snapdragon’s team.”

“I am extremely proud of what our team at Snapdragon has built over the years,” said Matt Bio, CEO of Snapdragon, in a press release. “With Cambrex, we have found an ideal home for our customers and employees, and I look forward to continued success as part of Cambrex.”

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

Cambrex is aiming to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing, especially with Snapdragon’s expertise in continuous flow manufacturing and complementing recent investments in continuous flow process development capabilities.

Cambrex Acquires Snapdragon Chemistry

Agilent Technologies announced a $725 million investment in nucleic acid-based therapeutics on Jan. 9, 2022. Therapeutic nucleic acids, also known as therapeutic oligonucleotides or oligos, are short DNA and RNA molecules that serve as the active pharmaceutical ingredient (API) for various drugs. The investment will be used to double manufacturing capacity to produce APIs.

According to a company press release, the investment will add two new manufacturing lines (Trains C and D) to Agilent’s Frederick, Colo., facility. The expanded facility will employ advanced automation and engineering enhancements such as water reduction and solvent capturing and recycling. Customer shipments from the expansion are expected to begin in 2026.

“One of our strategic priorities is to help existing and new biopharma customers develop, globally commercialize, and accelerate growth of oligo-based therapeutics,” said Sam Raha, president, Diagnostics and Genomics Group, Agilent, in the release. “This additional capacity will enable us to meet strong demand for siRNA [small interfering RNA] and antisense molecules and also significantly increase the number of CRISPR [clustered regularly interspaced short palindromic repeats] guide RNA programs we can take on.”

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

Agilent Invests $725 Million in Nucleic Acid-based Therapeutics

Nova Biomedical, a life sciences instrument provider, recently announced the launch of the BioProfile FAST CDV, a high-throughput, fully automated viable cell density and viability analyzer. The device uses trypan blue dye exclusion methodology for determination of live and dead cells, as well a high-resolution camera/optics to provide cell density and cell viability measurements.

According to a press release from Jan. 3, 2023, the analyzer is capable of producing results in less than 70 seconds with 100 microliters of sample volume. It also performs all sample dilutions internally, which allows cell culture samples up to 140e⁶ c/mL to be analyzed without external sample dilution. The device can sample cell cultures via an external 36-position loans-and-go tray or via a 96-well plate option.

The software associated with the device has a built-in touch screen display and icon-based navigation. Its software and networking capabilities are 

 compliant and have also been designed to meet FDA’s new cybersecurity guidelines.

“We at Nova Biomedical are excited to launch the next addition to the BioProfile platform with the FAST CDV Analyzer,” said Matt McRae, Biotechnology Sales Product line manager, Nova, in the release. “The FAST CDV is a significant advance in automated cell density analyzers and breaks the boundaries of existing technologies. It will enable even faster evaluation of cell lines and physicochemical parameter optimization, ultimately bringing products to market faster.”

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.