Avantor

Articles

Scaling production of mAb drugs remains a critical industry challenge – especially in downstream process chromatography steps. This Avantor White Paper details how technologies such as a novel protein A chromatography resin and the use of additives can improve efficiencies in this complex process step. It also reveals the potential for expanding single-use and continuous processing systems to help further streamline downstream production and improve cost profiles.

New Technology Advances Biopharma Chromatography Productivity

Finding more efficient ways to reduce processing times and improve downstream yields is a major bioprocessing industry challenge. In this study, two mAbs chromatography resins were examined. Both were used for a capture step, and additives were screened to reduce the nonspecific binding of impurities. The goal of the study was to optimize chromatography steps and thus increase the capacity and removal of impurities. 

Improving mAbs Impurity Clearance Through Use of Selective Additives

Pulmonary and nasal delivery are the preferred routes of administration for the majority of locally acting drugs exerting their effects on the airways or nasal mucosa. For both routes of administration, molecules are most often highly potent small molecules. Pulmonary products are primarily delivered via metered dose inhalers, Dry Powder Inhalers (DPIs) with carrier-based formulations, or nebulized solutions; nasal products are delivered as liquid solutions or suspensions. Drug pipelines have now expanded to include inhaled high-dose products, biotherapeutics (peptides, proteins, gene therapies, and phages), and systemically acting therapeutics, which serve as alternatives to intravenous and sub-cutaneous injected dosage forms. New technologies, such as spray drying, are gaining traction to address the complexity of delivering these molecules through the pulmonary or nasal routes. This webinar will discuss challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches.



Spray drying as an approach for the development of carrier-free systems

Challenges and key considerations for spray-dried formulations for inhalation

Review of current technologies and approved products utilizing particle engineering approaches



Biopharma, Pharma, and consultants working in the oral inhalation space



Director Innovation and Partnerships - Orally Inhaled Delivery
Catalent

., has focused his career on developing drugs for respiratory delivery, leveraging nearly 15 years of experience developing inhalation products in industrial and academic settings. Watts joined Catalent from Savara Pharmaceuticals, where he spent four years working in pharmaceutical development on two late-stage inhalation programs. Prior to that, Watts was a Research Assistant Professor at the University of Texas at Austin, where he created and oversaw an aerosol testing lab, taught courses on pharmaceutical entrepreneurship and pharmacokinetics, and co-invented a novel dry powder inhalation platform.

Watts has served in multiple roles within the American Association of Pharmaceutical Scientists (AAPS), as a reviewer for several pharmaceutical journals, and as proceedings editor for the Respiratory Drug Delivery (RDD) conference.

Watts holds a doctorate in Pharmaceutics from the University of Texas at Austin.


University Faulty Scholar Associate Professor, Department of Industrial and Physical Pharmacy, College of Pharmacy
Purdue University, Indiana

., is a recognized expert in inhalation dosage forms and pulmonary drug delivery systems. He is an editor of AAPS PharmSciTech and an Editorial Board Member of nine pharmaceutical journals, including International Journal of Pharmaceutics, Pharmaceutical Research, and Journal of Pharmaceutical Sciences. He has published over 100 journal articles and filed eight patents/applications. Zhou’s research has attracted more than $8 million in funding, including NIH R01 grants and many industrial projects. His significant contribution to the field of pharmaceutical science has been recognized with many prestigious awards, including the 2021 AAPS Emerging Leader Award, the 2019 DDL Emerging Scientist Award from The Aerosol Society, the 2018 Rising Star Scholarship Award from the National Institute for Pharmaceutical Technology & Education (NIPTE), the 2017 New Investigator Award from International Society of Aerosols in Medicines (ISAM), and the 2016 Emerging Researcher Award from International Pharmaceutical Excipients Council of the Americas Foundation (IPEC).
Zhou holds a doctorate in pharmaceutics from Monash University, Victoria, Australia.

Webcasts

Wednesday, November 16, 2022 at 11 am ET | 8 am PT | 4 pm GMT | 5 pm CET
This webinar will discuss challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches. 

Formulation Technologies for the Development of Dry Powders for Inhalation 

With multiple, complex chromatographic purification, buffer exchange, and viral inactivation steps, downstream processing of monoclonal antibodies (mAbs) remains the major bottleneck in biopharmaceutical production. This webinar will discuss critical evaluation and selection considerations for proper materials and reagents during process development and how these considerations are crucial in developing and optimizing a robust purification process. The webinar will also examine how a novel affinity chromatography resin, combined with selective additives, offers enhanced purification and improved removal of impurities, such as host cell proteins, DNA, and viruses, providing a model for the kinds of steps that can be taken to lead to improvements in overall mAbs manufacturing process efficiencies.



Provide insights into key aspects of efficient viral inactivation and purification in the context of an overall virus safety assessment and control strategy purification

Review how proteins-based affinity ligands can be better engineered and provide increased purification of FC-fusion proteins

Show how the combination of a novel Protein A affinity chromatography resin with select additives further enhances impurity removal.



Biopharma production professionals —downstream process engineer, downstream scientist, manager downstream process development, production and operations manager, research scientist



Senior Manager, Bioprocess Applications
Avantor, Inc.

 joined Avantor in September 2021 and is Senior Manager, Bioprocess Application, at Avantor Technology & Innovation (T&I). He is focused on applications of new products and processes to overcome challenges in biologics manufacturing for multiple therapeutic areas. Prior to joining Avantor, Tuhidul worked as a process development manager at Thermo Fisher Scientific, designing and developing downstream processes for different biologics drug modalities, scale-up, and technology transfer to CGMP. He also worked at AGC Biologics for late-stage process development. Tuhidul holds a PhD in Biochemical Engineering from Jacobs University, Germany, with a particular focus on protein purification method development, and spent several years as a postdoctoral researcher at BTEC, NC State University, United States. These experiences afforded him opportunities to learn various aspects of process development and manufacturing sciences of monoclonal antibodies, fusion proteins, adeno-associated virus, and lentivirus.

Tuesday, November 8, 2022 at 11 am EDT | 10am CDT | 8am PDTThis webinar will provide a detailed look at successful procedures for developing effective viral clearance and purification strategies to improve mAbs downstream process efficiency through enhanced engineering of a novel Protein A resin, combined with selective additives in key process steps. The webinar will include details on new techniques and recommendations for optimizing process steps, to help reduce costs and process time and increase downstream yield.

Increased Viral Clearance in Downstream Process Manufacturing Efficiency of Monoclonal Antibodies Through Use of Novel Purification Resin and Additives