DPT webinars provide information on topics related to drug development and manufacturing.
Strategies for Successful Scale-up Using Quality by Design
Successful scale-up from clinical-scale to commercial-scale production is imperative for realizing the market opportunities for a drug product. As pharmaceutical companies adopt Quality by Design (QbD), scalability is even more challenging and complex. Realizing the benefits of QbD requires setting a foundation in development by identifying critical quality attributes (CQA) and critical process parameters (CPPs) and understanding how those CQAs and CPPs may need to be redefined with scale-up and related modifications in equipment, material attributes or process changes.
This 60-minute webcast will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up and commercial manufacture.
QbD Based Formulation Development – The DPT Labs Approach
DPT Labs’ QbD Formulation Development service leads a customer through a rigorous process that minimizes risks to development success. Beginning with a Quality Target Product Profile (QTPP), the service further examines and narrows down formulation choices through a strategic process involving pre-formulation and preliminary stress testing activities, prototype formulation development, analytical method development, and informal stability testing.
Quality by Design – What is QbD and Why Should You Care?
Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone.
Risk Management in Sterile Manufacturing – Part 2
This webinar is a continuation of our discussion about sterility assurance. Sterility assurance is a critical component in the planning and manufacturing of pharmaceutical products. Good risk management consists of identifying and assessing risks prior to the manufacturing process as well as taking measures during the production process to control, mitigate, or eliminate risks.
Risk Management in Sterile Manufacturing – Part 1
Sterility assurance is a critical component in the planning and manufacturing of pharmaceutical products. Good risk management consists of identifying and assessing risks prior to the manufacturing process as well as taking measures during the production process to control, mitigate or eliminate risks.
Optimizing Topical Drug Development and Manufacturing
This webinar provides insight from leading industry experts on recent advances in topical formulation development, the latest regulatory/pharmacopoeial requirements in product quality and product performance, and strategies to optimize manufacturing for topical drug products. Drawing on decades of experience in semi-solid formulations, DPT describes how to efficiently develop and manufacture topical formulations, a dosage form that can improve patient compliance and bypass bioavailability problems encountered with oral administration.
In discussing topical formulation development the webinar presenters discuss what to consider when designing a drug delivery system and strategies to ensure stability – which is particularly important given the potential impact of sunlight, known as photosafety, on topical drug formulations.
This one-hour topical formulation development webinar continues our series focused on providing practical and engaging educational information on drug development and manufacturing processes.
DPT & Proveris Scientific Joint Webinar
DPT & Proveris Scientific hosted a joint webinar on obtaining the right data for inhalation products. Experts from both organizations explained how pharmaceutical manufacturers ensure the right bioavailability and bioequivalence data is obtained for inhalation products in development. In 2003 US Food and Drug Administration (FDA) issued draft guidance titled ‘Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action’. Getting this step right is a key aspect of regulatory approvals.
Technology from Proveris Scientific helps DPT generate data FDA wants, such as actuation parameters for automated spray pattern, plume geometry, shot weight, and droplet size distribution for in vitro studies. In this webinar experts from both companies discuss what steps developers of inhaled products, such as nasal sprays and must take to generate bioavailability and bioequivalence data.
This one-hour webinar was the first in a series focused on providing practical and engaging educational information on drug development and manufacturing processes.