Drug Products

Area Coordinators: Ted Randolph and Erinc Sahin

Drug Products:

Session: Drug Delivery for Biopharmaceuticals:  Novel Formulations and Mechanisms

Session: Devices and Biopharmaceutical Drug Delivery: Interactions and Strategies

Session: Big Data and Biomanufacturing

Session: Analytics for Biopharmaceutical Drug Products

Session: Quality assurance challenges for biopharmaceuticals: single use processing containers, primary packaging, delivery devices, and excipients


Session: Drug Delivery for Biopharmaceuticals:  Novel Formulations and Mechanisms

Session chairs:

Name: Bahar Demirdirek

Affiliation: Bristol-Myers Squibb 

Email: bahar.demirdirek@bms.com      

 

Name: Mary Krause    

Affiliation: Bristol-Myers Squibb

Email: mary.krause@bms.com  

 

Session description:

Novel drug delivery and controlled released strategies are evolving across the industry in response to unique challenges with pharmacokinetics, efficacy and safety of biopharmaceuticals. In recent years, development of biotherapeutic drug products has advanced to include antibodies, antibody drug conjugates, proteins, peptides, and oligonucleotides, among others. Delivery of these biomolecules can add an extra layer of complexity as compared to small-molecule counterparts, as biomolecules are often more sensitive to their environment, both before administration and once inside the body. In addition to formulation strategies, other technologies are being explored. This session invites presentations related to novel drug delivery and controlled release strategies and technologies, including nanoparticles, liposomes, hydrogels, as well as unique formulation approaches. Discussions of targeted delivery systems, as well as novel pulmonary and ocular technologies are also welcomed.

  

Session: Devices and Biopharmaceutical Drug Delivery: Interactions and Strategies

Session chairs:

Name: Chris Weikart

Affiliation: SiO2 Medical Products

Email: weikart1@att.net

 

Name: Diane Doughty

Affiliation: MedImmune

Email: DoughtyD@MedImmune.com

 

Session description:

Biologic drug discovery, manufacturing, packaging and delivery involve a plethora of interactions with materials that can affect drug efficacy, safety and ultimately regulatory approval. The sensitivity of biologic drugs to traditional materials such as borosilicate glass, plastics and silicone oil lubricants has their limitations. A clear understanding of the mechanistic interfacial interactions between drug products and materials continues to foster innovations in all aspects of drug development and delivery. This session calls for presentations that showcase advances in material science, interfacial science, formulation science and device engineering that advances the efficacy and safety of biologic drugs. This could include primary packaging such as syringes, vials and cartridges as well as lab or manufacturing consumables such as microplates, pipette tips, centrifuge tubes, tubing, filters, etc.       

  

Session: Big Data and Biomanufacturing

Session chairs:

Name: Abhijat Vatsyayan

Affiliation: Bristol-Myers Squibb

Email: abhijat.vatsyayan@bms.com

 

Name: Jerome Fox

Affiliation: University of Colorado, Boulder

Email: jerome.fox@colorado.edu

 

Session description:

Extremely large datasets are increasingly important in the analysis—and control—of complex systems, and for both the improvement of product quality and the optimization of operations in biomanufacturing. High quality analytical data, when coupled with sophisticated computational analyses, can reveal patterns in biological function or relationships between process parameters that might be difficult to intuit. This session encourages presentations focused on the application of data science to problems in biomanufacturing (including product discovery, product development, and quality control). Presentations describing experimental methods, computational analyses, or tools, techniques, and infrastructure for collecting isolated datasets into "big data" (and for processing those datasets) are encouraged.

 

Session: Analytics for Biopharmaceutical Drug Products

Session chairs:

Name: Christopher Garvin

Affiliation: Amgen, Principal Engineer

Email: garvinc@amgen.com

 

Co-chair: TBD

 

Session description:

Biologics process development and manufacturing involves complex process dynamics that result from interactions between and variability within chemical (e.g., raw materials), physical (e.g., process equipment), and biological (e.g., host cells) components. To improve process understanding and control, it is necessary to extract and analyze, in real-time, the large quantity of data generated by these processes toward the goal of managing variation, reducing risk, increasing process yields, and improving product quality. This session will focus on the advanced analytical technologies used to generate real-time data throughout the biologics manufacturing value chain and product lifecycle, the modeling techniques used to analyze and interpret the data, and the systems and procedures put in place to act on this information in a regulated environment. We also welcome applications from other industries especially Food Industry where real-time analytics may been a common practice.

 

Session: Quality assurance challenges for biopharmaceuticals: single use processing containers, primary packaging, delivery devices, and excipients

Session chairs:

Name: Cenk Undey

Affiliation: Amgen, Executive Director

Email: cundey@amgen.com

 

Name: Pankaj Paranjpe

Affiliation: Celgene, Director

Email: pparanjpe@celgene.com

 

Session description:

Although Quality by design (QbD) is an oft repeated cliché when talking about pharmaceutical products and manufacturing processes, it can provide significant advantage when developing commercial ready products. 

Biologics present inherent complexity when compared to small molecules and hence it is challenging to establish correlation between quality attributes, process parameters and derive the design space for supporting QbD. This increases the challenges for robust quality assurance approaches for Biologics in general. Among the multitude of factors which define the product and the process , for Biological drug products, the key input parameters other than the drug substance itself center around primary packaging components like glass vials and rubber stoppers, devices like pre filled syringes and auto injectors, containers used for drug product unit operations like DS storage, thawing, mixing, compounding and pooling, and the excipients used to convert the drug substance to a patient and supply chain friendly product. Raw material variability needs to be well understood and controlled to better manage risk and also optimize biopharmaceutical processes. There have been a variety of procedural and automated controls as best practices in place to assure quality of the final product as it pertains to raw materials including single use containers, primary packaging, delivery devices and excipients. However, biopharmaceutical industry also faces a lot of challenges given the complicated supply chain of these entities that require novel thinking and new approaches.

This session will focus on aspects related to these inputs (single use tech, primary packaging and devices, excipients) and their impact on product quality and applying QbD mindset while developing biologics drug products and will discuss the biopharmaceutical industry’s quality assurance challenges with raw materials, current and best industry practices as well as novel methods and technologies. New approaches will include data analytical predictive technologies from big data domain including electronic data transfer with suppliers, data standardization, systematic data collection for component traceability and monitoring towards controlling raw material variability.