Jill Murphy

Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced on Sept. 13, 2023 that it has received the cGMP Manufacturing Compliance Certificate following a successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at the UK site. According to the press release, the ATMP business was announced in early 2021 and the facility is in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, UK.

“MHRA’s approval marks a major milestone for Rentschler Biopharma, and we are excited to offer our services from process and analytical development through cGMP manufacturing. Our team is highly knowledgeable, bringing years of experience in the field of AAV,” said Dr. Robert Panting, general manager of Rentschler’s ATMP business, in a press release. “We provide a tailored program for each client, in line with their needs and stage of development, while working closely with them to move projects forward as rapidly as possible. We are thus continuing the Rentschler tradition of offering a truly client-centric approach with the ultimate goal of helping patients. With our first clients already on board, we look forward to adding other exciting programs soon.”

According to the press release, following the MHRA inspection, Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

“Our contribution to improving the health and quality of life of seriously ill patients, is made possible by continuously expanding our expertise in the production of essential biopharmaceuticals. By launching Rentschler’s ATMP business, we aim to address an important gap in expertise and support for innovative, early-stage cell and gene therapy programs,” said Dr. Christian Schetter, chief scientific officer of Rentschler Biopharma, in a press release. “It is gratifying to achieve this important milestone of MHRA approval, bringing us closer to reaching our objective of supporting clients already from the earliest stages of CMC development. We are continually looking to understand not only current client needs but future ones as well, which is how our ATMP offering came to fruition. We will continue to listen to our clients to anticipate how we can improve our offering and collaborate in advancing medicine to save lives, together.”

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Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

Rentschler Biopharma ATMP Facility Receives MHRA Approval

Nurix Therapeutics announced on Sept. 7, 2023 that it has entered a multi-year, multi-target strategic collaboration agreement with Seagen, to further advance a new class of medicines, called degrader-antibody conjugates (DAC), for use in cancer treatment. According to the press release, the collaboration between the two companies will focus on an innovative approach to combine two powerful technologies to target cancer, antibody-drug conjugation (ADC) and targeted protein degradation (TPD), with the intention of creating drugs with new mechanisms of action, improved specificity, and anti-cancer activity.

“By combining the tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins, we believe that DACs may represent a next generation of cancer medicine for a wide range of solid tumors and hematologic malignancies,” said Arthur T. Sands, MD, PhD, president and chief executive officer of Nurix, in a press release. “With Seagen, our strategic goal is to advance ADC technology to the next level to provide patients with new DAC drugs that deliver greater anti-tumor efficacy and safety compared to currently available agents.”

According to the agreement terms, Nurix will receive an upfront payment of $60 million and the potential to receive up to approximately $3.4 billion in research, development, regulatory, and commercial milestone payments across multiple programs. Further, as a part of the multi-year collaboration, Nurix will use its proprietary DELigase platform to develop a suite of targeted protein degraders against multiple targets nominated by Seagen that are fitting for antibody conjugation. According to the press release, Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

“The targeted protein degrader modality provides unique advantages over payloads currently employed across the ADC field,” said Gwenn M. Hansen, PhD, chief scientific officer of Nurix, in a press release. “This collaboration is a new application of our DELigase technology, and we are delighted to work with Seagen, a pioneer in the development and commercialization of ADC therapeutics, to create a new generation of drugs to fight cancer.”

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Nurix Announces Strategic Collaboration with Seagen

On Sept. 6, 2023, Charles River Laboratories International and PathoQuest announced the publication of the results of a seminal study in 

, which demonstrated the proprietary, good manufacturing practice (GMP) grade, next-generation sequencing (NGS)-based assay from PathoQuest had a greater capability of detecting viral contaminants when compared to 

The objective of the study was to compare classical 

 testing methods used to screen cell lines for adventitious viruses with a GMP-compliant viral transcriptome NGS assay. Further, the study was conducted as a head-to-head comparison of standard 

testing and NGS-based testing of cell substrates.

According to the press release, the team of Charles River experts prepared test materials and ran the 

 assays, while PathoQuest’s team tested the material with their proprietary NGS-based assay. There were cells infected with a wide variety of viruses reflective of the diversity and various patterns of virus-cell interactions in a real-world setting for biologics to determine the range of detection. Additionally, the infected cells were increasingly mixed with uninfected cells to further assess the analytical sensitivity and analyzed across several conventional 

 tests and with the NGS-based transcriptomic assay.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to 

 adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

“Our study demonstrates that PathoQuest’s unique NGS assay significantly increases the capability of detecting viral contaminations in cell substrates like cell banks, the starting material for biologics production, and in bioreactors during biologics production. The test has been validated to GMP standards and provides the pharmaceutical industry a faster, more efficient, and reliable testing option compared to animal-based testing,” said Professor Marc Eloit, DVM, PhD, head of the Pathogen Discovery Laboratory at the Institute Pasteur and Founder of PathoQuest, in a press release.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Charles River and PathoQuest Publish Study Validating Proprietary Next-Generation Sequencing Viral Safety Assay 

Orano Med and Orbit Discovery announced on Sept. 11, 2023 that they have entered a collaboration to discover specific peptide receptor radionuclide therapies against cancer cells and advance the development of novel radiopharmaceuticals. According to the press release, the agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

“We’re delighted to continue expanding our existing portfolio of partners by collaborating with Orano Med who have a strong track record of discovering novel radiopharmaceuticals,” Neil Butt, chief executive officer, Orbit Discovery, said in a press release. “We’re very proud of our proprietary screening platform at Orbit and acknowledge its role in empowering the next wave of peptide therapeutics.”

Radioligand therapies rely on the concept of combining the ability of biological molecules, like peptides, to target cancer cells with the short-range cell-killing capabilities of radioisotopes. According to the release, the approach results in an increased cytotoxic potential toward cancer cells while still limiting toxicity to nearby healthy cells.

This collaboration will strengthen the capabilities of Orbit’s peptide display engine to identify peptide candidates specific to tumor-associated targets, and the technology enables the screening of large peptide collections through the combination of DNA encoded libraries and bead-based presentation, according to the press release.

“Since the inception of Orano Med, we have recognized the value of collaboration,” said Julien Dodet, chief executive officer, Orano Med, in a press release. “In our strategy to develop and deliver 212Pb Targeted Alpha Therapy for cancer patients, we’re delighted to work with Orbit Discovery and leverage its technology and expertise in peptide ligand discovery to build our pipeline of radiotherapies.”

The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

Orano Med and Orbit Discovery Enter Collaboration for New Novel Targeted Radioligand Therapies 

Optibrium announced on Aug. 31, 2023 the acquisition of BioPharmics to further expand the 3D drug design and modelling offering and to focus on research and development and application science, according to the press release.

BioPharmics developed a series of industry-leading algorithms and software for 3D ligand-based and structure based computational drug design, including software for 2D to 3D ligand conversion and conformer generation, molecular docking, molecular similarity, and binding affinity prediction. Additionally, these highly performant products have all been analyzed and their results demonstrated in numerous peer-reviewed papers, specifically published jointly with key pharmaceutical industry partners, according to the release.

“After years of close collaboration, we are delighted that Optibrium was chosen to support BioPharmics’ continued scientific innovation and expanding customer base,” said Dr Matthew Segall, CEO, Optibrium in a press release. “We are delighted to welcome Ajay and Ann to the team. Their extensive experience in computational chemistry and biology, alongside BioPharmics’ world-leading software for 3D ligand- and structure-based design, will bring Optibrium to the forefront of these essential technologies for small molecule discovery and design.”

Dr Ajay Jain, founder and CEO of BioPharmics, added that their team believes that there is no better team to continue the powerful software developments that BioPharmics has introduced over the years. “I look forward to working as part of the Optibrium team to expand their internal expertise in 3D drug design, as well as on future drug discovery innovations,” he said in a press release.

Optibrium announced on Aug. 31, 2023 the acquisition of BioPharmics to further expand the 3D drug design and modelling offering and to focus on research and development and application science.

Optibrium Acquires BioPharmics

Analytical testing forms a vital part of the development lifecycle of bio/pharmaceutical drugs as it provides assurances of the safety and effectiveness of the products prior to patient use. As industry focuses on more complex molecules, growth within the analytical testing services sector is inevitable. In fact, according to recent market research, the sector is expected to experience compound annual growth of 11.4% between 2022 and 2027 (1), largely driven by the swell of biologics and biosimilars in development.

Another aspect altering the analytical testing landscape has been the COVID-19 pandemic, which significantly boosted demand for clinical services as numerous companies raced to develop safe and effective vaccines and medicines to treat the disease.

Since the start of the COVID-19 pandemic, there has been a greater level of investment into analytical testing and services, points out Kishore Hotha, vice president, Global Head of Analytical Research & Development at Veranova.

“The shift to remote work has also impacted the industry, prompting the development of remote analytical testing technologies to support remote operations,” Hotha adds. “Moreover, the pandemic has accelerated the utilization of artificial intelligence (AI) and machine learning (ML) in analytical testing. These technologies offer automation, improved accuracy, and efficiency in testing processes while enabling the identification of potential drug-related issues. Additionally, there has been a heightened emphasis on personalized medicine, which involves tailoring drugs and treatments to an individual’s genetic makeup and medical history.”

In terms of identifying genetic markers associated with diseases and targeted therapies, Hotha feels the changes should persist in the post-pandemic era, as the pharmaceutical industry develops novel drugs and treatments to address unmet patient needs. “Overall, the COVID-19 pandemic has therefore catalyzed advancements in analytical testing, promoting innovation and enhancing the industry’s ability to deliver safe and effective pharmaceutical solutions,” he says.

A prime example of innovation that is helping to expedite testing processes is the rising use of robotics and AI, according to Hotha. These kinds of technological advances benefit both the patient and the pharmaceutical company when utilized properly.

“Labs are implementing new processes in analytical drug testing to enhance safety, efficacy, and efficiency. These include using robotics for automated tasks, cloud-based data storage and analysis, AI, and machine learning (ML), and personalized medicine approaches,” Hotha says. “Robotic systems automate tasks like pipetting and centrifugation, improving accuracy, efficiency, and cost-effectiveness. Cloud-based systems enable seamless data sharing and collaboration, enhancing testing accuracy and efficiency while facilitating the development of novel methods. AI and ML aid in developing new testing techniques, identifying potential drug issues, and improving result interpretation.”

In the case of personalized medicine, testing needs to be individualized to the patient, taking into account genetic makeup and medical history, specifies Hotha. “[Automated] processes foster safer and more efficient drug development, making testing more affordable and accessible. Labs can accelerate testing, improve accuracy, and reduce costs by leveraging automation, data-driven analysis, and tailored approaches,” he emphasizes.

Efficiency: cost versus development time?

For Hotha, analytical drug testing services continue to be highly beneficial for pharma companies, particularly in the face of emerging trends in the industry. He explains that the increasing demand for personalized medicine, which focuses on tailoring drugs and treatments to individual patients based on their genetic makeup and medical history, has created a significant need for robust analytical testing.

“These services play a crucial role in identifying genetic markers associated with various diseases, enabling the development of targeted therapies,” Hotha comments. “Furthermore, there is a growing emphasis on safety and efficacy in drug development. Analytical drug testing services ensure that drugs are safe and effective before administering them to patients. They help assess pharmaceutical products’ quality, purity, and stability, ensuring that they meet regulatory standards and minimize potential risks.”

In addition, researchers are working on treatments for more intricate diseases, which is leading to an increasingly complex drug development landscape, Hotha continues. “Analytical drug testing services play a vital role in unraveling the complex mechanisms underlying these diseases and aiding in developing effective treatments. Through advanced analytical techniques and data-driven approaches, these services enable scientists to gain insights into the intricate aspects of drug behavior and optimize their therapeutic interventions,” he says. “Analytical drug testing services remain indispensable for pharma companies to develop high-quality, targeted therapies that meet the evolving needs of patients and regulatory requirements.”

Contract development manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) are a major component to vaccine and therapy development, as well as fill/finish operations, toxicity testing, and cost control. In terms of analytical testing, CDMOs/CMOs are hoping to enhance their testing services and make the changes necessary to do so, according to Hotha.

Hotha points out that there are some fundamental approaches to improve efficiency, accuracy, and customer satisfaction, including investment in advanced technologies, expanded testing capabilities, focus on quality systems and compliance, and collaboration/partnerships. For example, expanded testing capabilities hope to cater to broader client needs, he reveals.

In terms of collaboration and partnerships, Hotha adds that specialized testing laboratories collaborate well with CDMOs/CMOs. “Collaborations enable CDMOs/CMOs to offer comprehensive solutions and access a broader range of testing services, contributing to their competitiveness,” he says.

“Success for CDMOs/CMOs in the testing services realm is achieved through a combination of factors,” Hotha continues. “A robust infrastructure, skilled personnel, adherence to strict quality standards, and customer-centricity are critical. CDMOs/CMOs consistently deliver high-quality testing services within defined timelines and budgets and tend to excel in the industry. Flexibility and adaptability in tailoring testing services to meet specific client requirements are highly valued. These strategic initiatives enable them to provide comprehensive, reliable, and customer-centric testing services, positioning them as preferred partners in the pharmaceutical industry to transform molecules into medicines.”

Testing can differ depending on the size of the molecule and the phase of development. The variances may also be based on the drug’s nature, therapeutic area, regulatory guidelines, and individual company strategies. Therefore, flexibility and adaptability in testing methodologies are critical to meet the specific needs of different molecules and development stages.

Large-molecule testing, involving biologics like proteins and antibodies, present more complex challenges than small-molecule testing, according to Hotha. “Large-molecule analysis requires specialized techniques such as mass spectrometry and nuclear magnetic resonance spectroscopy for structure and composition identification. Sample preparation for large molecules is more challenging due to their instability and susceptibility to degradation, necessitating specific preservation methods. Data analysis for large-molecule testing is also more intricate, as these molecules often have multiple subunits with varying biological activities,” he explains.

As for early phase versus late-phase development, Hotha emphasizes how different the testing requirements can be in each phase. “In early-phase development, the focus is on safety, toxicity, and dosage optimization. Analytical methods concentrate on identifying and characterizing drug candidates, stability assessments, and early safety evaluations using qualified analytical test methods with minimum requirements,” he adds. “Late-phase development involves comprehensive testing to meet regulatory safety, efficacy, and quality standards. This includes extensive validation, impurity profiling, stability studies, and method transfer/validation for commercial production.”

The future of analytical drug testing services

In Hotha’s opinion, the future of testing services holds significant promise for the pharmaceutical industry, with new analytical methods of technologies and more collaborations among analytical testing labs with other stakeholders and pharmaceutical companies to further improve the accuracy, efficiency, and reliability of drug testing. “Improvements in technology, automation, and data analytics will enhance the speed and precision of testing processes, leading to quicker turnaround times for results and faster decision-making in drug development,” he summarizes. “Integrating advanced analytical techniques such as mass spectrometry, high-throughput screening, genomic analysis, and imaging will provide a comprehensive understanding of drug properties and mechanisms of action. This knowledge can drive the discovery of new therapies and the optimization of drug formulations.”

Healthcare Analytical Testing Services Market by Type (Biomarker Testing, Stability Testing, Raw Material Testing, Batch-Release Testing, Cleaning Validation), End User (Pharmaceutical Companies, Medical Device Companies, CRO), and Region—Global Forecast to 2027

The focus in labs is leaning more heavily toward automated processes while at the same time maintaining efficiency, safety, and a personalized experience for the lab worker.