Biopharma thought leadership
As the FDA signals stronger support for advancing gene therapy approvals, manufacturers face increasing pressure to get to market quickly. Ger Brophy tackles emerging scale-up challenges to efficiency and safety, with an in-depth look at optimizing viral vector production, managing costs, and collaborating on industry standardization and automation.
Formulation challenges are complex, with the potential to delay — or derail — commercialization of breakthrough mAbs. This article discusses the latest research in excipients and buffer composition, as well as manufacturing considerations, to develop a stable and patient-friendly commercial mAb.
The final critical steps in commercial monoclonal antibody (mAb) manufacturing — from bulk drug substance collection through formulation to final sterile filtration and fill — present several ongoing challenges that demand meticulous attention to detail and a well-thought-out process. This article offers solutions for operational excellence to optimize efficiency, mitigate risk and speed up time to market.
Single-use technologies are now an integral part of the bioprocessing manufacturing landscape – and we continue to see rapid growth in this area with the development of new components and processes. Single-use fluid pathways offer significant manufacturing flexibility and process efficiency for multiple biopharma modalities, but this doesn’t mean that everything is perfect.
Production of viral vectors, such as adeno-associated virus and lentivirus, is a complex process and requires innovative approaches to maintain their long-term stability and efficacy in the final gene therapy product. Scaling to larger volumes exacerbates manufacturing challenges, however, significant advancements have been made at each step in the manufacturing workflow to ensure the integrity and quality of the final product.
As gene therapy expands, the scalability of bioproduction processes, especially cell lysis, has become a critical challenge. This white paper examines how the J.T.Baker® Cell Lysis Solution delivers a compliant, easy-to-use alternative to traditional detergents, streamlining operations at scale while supporting viral vector integrity and downstream compatibility.
It is essential to consider cGMP compliance early in development rather than waiting until late clinical trials and/or large-scale production. This article explores how using well-characterized, high quality and cGMP raw materials and reagents earlier in the transition to large-scale commercial manufacturing can avoid process changes, bottlenecks and delays.
New bispecific antibodies show better cancer-fighting promise as compared to traditional monoclonal antibodies, but they can create process difficulties due to aggregation and instability. Study results show the efficacy of new technologies that address these challenges, so customers are better prepared to meet growing demand and patient need.
To ensure the safety of biopharmaceuticals derived from mammalian cell culture, it is critical biomanufacturing processes can clear or inactivate potential viral contaminants.
Buffer preparation consumes a substantial portion of a manufacturer’s facility footprint and overall cost, labor requirements and equipment. A review of four case studies explores how Avantor customers resolved their buffer management challenges with custom solutions to reduce manufacturing floor space and save time and expenses.
Most monoclonal antibodies (mAbs) are developed with low protein concentrations, and typically delivered to the patient in liquid form via injection or intravenous infusion (IV). However, there are a growing number of indications that prefer intramuscular or subcutaneous injections - mainly so that a patient can self-administer the drug at home and reduce hospital stays and/or treatment costs, increasing patient compliance.
The scale-up of monoclonal antibodies (mAbs) from pilot to production is a well-established process, but opportunities to further de-risk and improve processes - using platform products and technology - are available today. Innovations in raw materials, equipment and single-use technology continue to emerge in response to high market demand. Technology choices and decisions should be considered very early in development to avoid obstacles and maximize efficiency, as the stakes have never been higher.
Insufficient planning, in the early stages of mAbs scale-up, results in an inefficient process at best, or validation failures leading to serious market delays at worst. Using cGMP grade reagents earlier in the transition to large-scale commercial manufacturing makes for a seamless transition. Read about benefits and background in our GMP fact sheet.
Artificial Intelligence offers a new smart technological approach to reducing the complexity of the single use component library supply chain. Learn how predictive forecasting based on real time usage, with positive feedback to the original manufacturer drives anticipative demand.
Dr. Ger Brophy, EVP Biopharma Production, provides insights into manufacturing challenges, including scale up, mitigating raw material shortages and supply chain issues, and other industry trends during his interview at 2022 Biotech Week Boston.
Biopharma companies should consider these four best practices as they develop and manage their single-use supply chain.
Avantor’s Dr. Ger Brophy recently joined three industry colleagues for a pre-CPhI 2022 panel discussion hosted by The Medicine Maker magazine, discussing key biomanufacturing challenges.
How a new training room at Avantor Fluid Handling is ensuring the reliability and quality of your single-use systems
Monoclonal antibodies still dominate the world of biopharma. Given that 60–80 percent of mAb production costs can be attributed to downstream processing, removing downstream bottlenecks, and improving yields will continue to be an important priority for mAbs manufacturers – especially amidst rising demand. The following article, published in The Medicine Maker, is offering a few suggestions.
Monoclonal antibodies (mAbs) are the dominant therapeutic modality in the biopharmaceutical industry, representing the largest sector of the market. As of 2022, more than 100 mAb therapies have been approved by the FDA – over twice as many as had been approved only 5 years ago.
Jonathan Fura and Navjot Kaur provide insight into pain points in mRNA manufacturing and into the solutions that can evolve through the supplier-manufacturer relationship.
Opinion piece by Arvind Srivastata, Technical Fellow, describing the problems than can occur in viral vector production, and offering solutions based on a collaborative model that standardizes processes.
Across the biopharma industry, manufacturers of mRNA vaccines and therapeutics are seeking new tools and resources to help improve the safety, stability and quality of their mRNA drug products. Read about two key resources that can support scale-up production.
Arvind Srivastava, Technical Fellow; Ger Brophy, EVP, Biopharma Production Solutions and Meera Agarkhed, former Sr. Manager, Technology and Innovation discuss how formulations containing citrate compare to other buffers in reducing SC injection-site pain in a peer reviewed paper.
Approaching raw material characterization with Biopharma 4.0 thinking in addition to robust collaboration between producers, vendors and end-users may improve biopharma manufacturing processes.
What is the purpose of chromatography in downstream processes of mAbs therapeutic manufacturing? And how does Avantor’s premium protein A chromatographic resin and single-use technologies to address the challenges of manufacturing a safe and effective final product? Learn more in this piece by Nandu Deorkar, Ph.D., M.B.A., Senior Vice President R&D.
A discussion about the challenges and benefits of having a well-designed and properly composed fluid handling system using single-use technology. Correct design and adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.
Narayana Rao, Vice President, Biopharma, AMEA spoke to BioSpectrum in April 2021 about Avantor’s support of companies battling the global pandemic, and the potential of the AMEA region to meet COVID-19 vaccine needs.
The evolution of the monoclonal antibodies (mAbs) market, since approval of the first mAb more than 30 years ago, has dramatically changed patient care. Advances in technology as well as knowledge about antibody engineering have brought forth a wide range of targeted therapies to address previously unmet medical needs.
Adeno-associated virus (AAV) has emerged as a leading platform for gene delivery for treating various diseases due to its excellent safety profile and efficient transduction to various target tissues...
In producing monoclonal antibodies (mAbs), finding ways to remove bottlenecks and improve yields in downstream processing is a key focus area for biopharma manufacturers.
Cell therapies, including CAR-T and TCR-T, and gene therapies will offer transformative outcomes for challenging diseases.
Since the beginning of the COVID-19 pandemic in 2020, Avantor has innovated and pivoted to help customers develop and scale-up the production novel vaccines. While the pandemic dominated the work of biopharma and life science companies, Avantor was also able to address multiple, ongoing global needs and continue to focus on the importance of strong supplier-manufacturer collaboration.
Single-use systems have come a long way. Timothy Korwan and Sean DeFusco, single-use experts from Avantor, discuss biopharma’s experience with the technology so far – and consider why it has become a popular choice for producing new drugs.
COVID-19 has compressed bioprocessing timelines, leaving no room for uncertainty in the characterization of raw materials and contaminants.
Best practices in the semiconductor industry, including advanced materials analysis and characterization, can improve yields in biopharmaceutical production.
There has been significant change across the biomanufacturing industry over the last couple of decades, as increased complexity of biologics and a growing focus on smaller patient populations have led to a greater need for cost control and process efficiency.
Scaling up cell & gene therapies from research and development to commercialization is creating a new set of challenges for manufacturers...
Scaling up cell & gene therapies from research and development to commercialization is creating a new set of challenges for manufacturers...
It is common for biologics manufacturing processes to require hundreds of raw materials, ranging from media and media supplements, buffers, and salts to other process chemicals...
The term “optimize” is often applied to complex manufacturing, automation and business processes and implies that the most efficient function of all the elements of a process – technologies, sequences and procedures – has not been achieved...
With the rapid growth of single-use systems (SUS) for drug production, especially by drug manufacturers with multiple locations across the globe, there are many risks associated with underestimating the regulatory compliance, manufacturing and quality requirements of these systems...
Despite significant advances made in recent years to increase biologic yields as well as the intensity and consistency of these processes, there is still the potential for innovation in this area in order to reach more efficient production of therapeutic proteins...
Opportunities for advancements and challenges in manufacturing processes remain as the biopharmaceutical industry focuses on gene therapy.
Processing times can be reduced and yields increased by utilizing new hydrophobic interaction chromatography tools.
Continued expansion of the biosimilar marketplace has led to many commercial opportunities and technical challenges...
Q&A interview with Ger Brophy, Executive Vice President for Biopharma Production at Avantor.