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Overcoming Challenges in Ophthalmic Formulations through Polymer Selection – A Closer Look at Polyvinyl Alcohol

Ophthalmic drug formulations are growing in importance due to the increased prevalence of eye-related disorders such as diabetic retinopathy and macular degeneration. However, ocular drug delivery is challenging due to unique anatomical and physiological barriers such as pre-corneal loss factors including tear turnover, nasolacrimal drainage with potential systemic absorption via the conjunctiva or nasal mucosa, transient residence time, and the relative impermeability of the corneal epithelial membrane. The low ocular bioavailability (<10%) of conventional ophthalmic formulations is driving the need…

Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts to a biopharmaceutical after administration. Pharmacokinetic studies (PK) measure the variations of drug levels in the body as a function of time and are an essential part of the drug development process. Properly designed PK studies…

Host cell protein impurities in viral vector manufacturing: a critical quality attribute for product efficacy and safety

Viral vector manufacturing processes require rigorous analytics, including testing for process-related impurities such as host cell proteins (HCP), host cell DNA, growth media additives and enzymes used in viral vector purification processes [Cellular and Gene Therapy Guidances]. Even after multiple purification steps, significant levels of HCP impurities can be present. While low levels of most impurities can be inconsequential, patient safety demands that HCPs be eliminated or reduced to the lowest levels practical to prevent problems such as adverse immune…

Streamlining of Process Characterization Using an Automated Reactor System

This webcast features: Kyle Deluca, Senior Scientist, Engineering & Felix Milman, Specialist, Engineering, Merck. In an effort to improve the efficiency of large molecule process characterization work, the Bioconjugation and Chemistry Commercialization team at Merck looked to automate steps involved in the production of its vaccine pipeline candidates. The actions taken by the team included installation of an automated reactor system that would provide new process capability and allow reactions to be completed outside of business hours, while improving process…

Sterile Fill/Finish Manufacturing

The bio/pharmaceutical industry is rapidly changing with increased product complexity, shorter timelines, and a push from the FDA for less human intervention in aseptic processing. These changes can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art Vanrx Microcell Vial Filler…

Case Study – Merck Process Transfer and Scale-Up of Batch Chromatography to Multi-Column Platform

Traditional batch chromatography has high operating costs. Merck sought to evaluate the relative performance and costs of an MCC system. Learn how Merck achieved resin savings and productivity gains by implementing multi-column chromatography with the Sartorius BioSMB System. Key Learning Objectives: Learn how Merck achieved 3.5x higher productivity with MCC compared to batch mode See how the shift resulted in 80% reduction in chromatographic resin use Find out how Sartorius experts supported Merck’s process transfer Access this case study and…

BioProcess Insider Interview: Dr. Ger Brophy, Avantor

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Dr. Ger Brophy, Executive Vice President, Biopharma Production, Avantor. Avantor has expanded its biopharmaceutical capabilities significantly over the past year. In addition to opening facilities in The Netherlands and Massachusetts for manufacturing and distribution of single-use systems, respectively, the company has broken ground on sites in Ireland and Singapore. Avantor also acquired Masterflex, a manufacturer of peristaltic pumps and fluid-handling solutions. Brophy explained that such activity exemplifies Avantor’s efforts to increase…

How Our Partnerships Move Your Life-Changing Biologics to Market: Two Case Studies

Muctarr Sesay, chief scientific officer, Goodwin Biotechnology. Goodwin Biotechnology’s mission is to minimize manufacturing risks associated with complex biopharmaceuticals, including antibody–drug conjugates (ADCs), bioconjugated vaccines, and multispecific antibodies. Sesay described his company’s capabilities, which span from preclinical process development through commercial supply. Currently, the Goodwin site in Fort Lauderdale, FL, is equipped for 200-L and 500-L bioreactors in both stainless-steel and single-use formats. The company can perform drug substance and drug product manufacturing as well as fill–finish steps, all according…

BioProcess Insider Interview: Tom VanCott, Catalent

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Tom VanCott, PhD, Global Head of Product Development, Catalent. Contract development and manufacturing organization (CDMO) Catalent has expanded significantly over the past decade through strategic acquisitions and investments in cell and gene therapy (CGT) capabilities. VanCott reflected on how his company has supported such growth while manufacturing SARS-CoV-2 vaccines and therapeutics. Catalent was able to accommodate the sudden and extraordinary demand for COVID-19 products because it already had been increasing capacity…

BioProcess Insider Interview: Dave Backer, Oxford Biomedica

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: David Backer, Chief Commercial Officer, Oxford Biomedica. Early in 2022, Oxford Biomedica (OXB) purchased a majority stake in Homology Medicines. The companies have taken similar journeys, the primary difference being that they have worked with lentivirus (LV) and adenoassociated virus (AAV) vectors, respectively. Both companies started as drug developers and established manufacturing capacity to support internal products. Because of program attrition, OXB began offering its capabilities as a service. OXB now…