Insights On Drug Development

31. Venerated And Vital: Using Lipid Based Delivery For Fast And Efficient Early Phase Development 7/17/2019

    Introduced to the pharmaceutical industry decades ago, lipid-based drug delivery systems are the most well-studied and widely utilized technology among all available bioavailability enhancement technologies. Lipid-based drug delivery systems have delivered more than 60 unique drug molecules to market – and counting. Watch this webinar to learn more about the importance of and recent developments in lipid-based drug delivery systems, novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems, and using mechanistic studies and modeling to predict the impact of lipids on oral absorption.

32. Is Your Partner Prepared For Your Scale-Up Challenges? 6/26/2019

    Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, it is critical you find a partner that can help you overcome the challenges.

33. The Criticality Of API CDMO Selection: Insights From A Client 6/17/2019

    Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them.

34. Manage Risks In Development And Manufacture Of Potent Pharma Products 6/17/2019

    Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, is an effective strategy.

35. The Importance Of Inventory Management: Do You Know Where Your Samples Are? 6/12/2019

    With the exciting advances in research and drug development, the importance of sample management has never been higher. If you have ever experienced sample management mishaps, we ask: Do you know where your samples are? In this article, we’ll explore some of the common causes of inventory mismanagement and best practices to guard against sample loss and near misses.

36. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

37. Developing A High-Throughput Formulation Development Platform For High-Concentration, Therapeutic Monoclonal Antibodies 6/10/2019

    Some of the challenges in the early stages of a pharmaceutical are a limited supply of protein to use in formulation screening studies, and a need to obtain stability data quickly to initiate tox studies. In this poster, scientists at Catalent Biologics outline a method utilizing a high-throughput, micro-well plate platform to economically screen a mAb in 96 formulations.

38. How To Address Process Characterization And Late Phase Development Of A Monoclonal Antibody 6/10/2019

    Process characterization is an important step in the overall journey of product development. In this poster, scientists at propose a step-wise approach for the definition and execution of process characterization for the production of a monoclonal antibody.

39. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

40. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand 5/30/2019

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.