Lonza Pharma & Biotech


	Solid form screening and characterization is a critical part of drug substance development and preformulation. This webcast will discuss many aspects of solid form screening. The underlying fundamentals of polymorphism hydrates/solvates, salts, and cocrystals will be presented to establish a basic understanding of these systems. Regulatory guidance on solid form understanding will be discussed to provide a framework for what is required prior to IND and NDA filing. The importance of solid form screening and characterization in both drug substance and drug product develop, stability, and process development will also be discussed.

	Lonza provides solid form services that is integrated into both drug substance and drug product development with strong materials science expertise and state of the art equipment. Close collaboration of solid form screening with drug substance and drug product development improves the ability to leverage critical data to optimize product development activities. 

		Review the fundamental physical chemistry of polymorphs, solvates, hydrates, salts, and cocrystals

		Establish the regulatory requirements of solid form understanding

		Understand the importance of identifying and characterization critical solid forms

		Learn how a lead solid form is selected for development and its impact on drug product development

Michael Grass, PhD, Head of Solid Form Services, Global R&D, Lonza Pharma & Biotech

Thursday, Sep. 10, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Sep. 10, 2021

Webcasts

In this webcast, Michael Grass PhD (Head of Solid Form Services, Global R&D) will present how solid form screening is performed and the importance of this work to drug substance and drug product development.

Live: Thursday, Sep. 10, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Sep 10, 2021

Register free



Solid form screening and its role in drug development

http://www.pharmtech.com/pt_w/scale_up_approaches


	Spray-drying is a preferred process for manufacturing amorphous solid dispersions, which provide oral bioavailability enhancement for low-solubility small molecules. High permeability, low-solubility BCS Class II compounds are prevalent, representing approximately 70% of the new chemical entity pipeline, driving continued research and optimization of dispersion technology.

	This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale will also be highlighted.  

	In a scale-up case study of spray-dried Eudragit L100, a filament particle morphology was observed, leading to poor yields and very low bulk density. By controlling the formulation and process parameters, researchers identified a scale-independent process space where SDDs can be manufactured without filament formation at high product yields and with desired particle properties.

		Process optimization of the manufacturing aspects of amorphous spray-dried dispersions

		Tools and methodologies for scale-up from clinical to commercial phases

		How to avoid string formation at high product yields and with desired particle properties

Joel Wood, Product Development Engineer, Lonza Bend, OR

	Kim Shepard, Ph.D., Associate Principal Engineer, Lonza Bend, OR

US & Europe: Tuesday, Aug 4, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	Asia Pacific: Wednesday, Aug. 5, 2020 at 2pm Singapore | 2pm China | 3pm Japan | 3pm Korea

	On demand available after airing until Aug. 4, 2021

This webcast focuses on manufacturing aspects of amorphous spray-dried dispersions to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale will also be highlighted. 

Live: Tuesday, Aug. 4, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Aug. 4, 2021

Register free



Manufacturing amorphous solid dispersions by spray-drying: scale-up approaches


	Both spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This case study explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery. The head-to-head comparison reveals opportunities and risks for designing a product based on each approach.

		Understand the pros and cons of spray drying vs. jet milling

		Learn how to conduct a risk assessment to inform engineering technology selection

		Explore how particle morphology influences aerodynamic performance

Cameron Kadleck, Respiratory Scientist, Product Development, Lonza

	Jimmy Beaty, Respiratory Scientist, Product Development, Lonza

Thursday, Jul. 30, 2020 at 11am EDT | 8am PDT | 4pm GMT | 5pm CEST

	On demand available after airing until Jul. 30, 2021.

If you have a new compound for respiratory drug delivery, what particle engineering approach should you take? This webinar will explore both micronization and spray drying approaches in relation to product performance of the inhaled drug product.

Live: Thursday, Jul. 30, 2020 at 11am EDT | 8am PDT | 4pm GMT | 5pm CEST

On demand available after airing until Jul. 30, 2021

Register free



Engineering Approaches to Respiratory Drug Delivery: Mannitol Case Study

http://www.pharmtech.com/pt_w/complex_studies


	Specialized and coordinated activities are needed to provide effective and integrated clinical drug product supply for today’s clinical trial challenges. Specialty medicines, inclusive of orphan applications, often require global distribution coordination in order to reach sufficient patient population for clinical trials. Direct-to-Patient (DtP) is an increasingly required clinical supply service option that allows patients to get their clinical supplies without having to make the trip to a clinical site. Holistic manufacturing, packaging, kitting, distribution, and return services are often required capabilities to effectively handle primary and secondary clinical projects, which can include complex packaging scenarios.

	During this webcast you will learn about Lonza’s clinical services inclusive of integrated first-in-human solutions that can effectively support accelerated timelines. Selective case studies will be discussed that demonstrate best practices in complex packaging and DtP supply.

		Flexible packaging and distribution solutions

		SimpliFiH® Solutions first-in-human services

David Dreifke, Associate Director, Warehouse & Distribution, Lonza Pharma & Biotech

	Damian Gant, Associate Director, Supply Services, Lonza Pharma & Biotech

	David Lyon, Ph.D., Sr. Fellow, Research, Lonza-Bend, Oregon USA

Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Jun. 23, 2021

This webinar will review Lonza’s integrated clinical supply services inclusive of manufacturing, primary and secondary packaging, kitting, and distribution with special emphasis on complex clinical studies and direct-to-patient shipping.

Live: Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Jun. 23, 2021

Register free



Specialized Clinical Services for Complex Clinical Studies

http://www.pharmtech.com/pt_w/oral_peptide

	Technological enhancements in peptide discovery and synthesis are emerging to meet the increasing number of incidences of cardiovascular and metabolic diseases. However, targeted delivery of peptide drugs within the therapeutic range remains a significant challenge for the biopharmaceutical industry. Parenteral administration-including intravenous, subcutaneous, and intramuscular injection-remains the primary method for commercialized therapeutic peptides.

	From a patient perspective, oral administration is a preferred drug delivery method, providing improved patient compliance and facilitating outpatient therapy for chronic indications. Non-invasive delivery methods such as oral administration have increased over the past five years through the innovation efforts at start-up and big pharma companies. Indeed, the September 2019 approval of Rybelsus, (semaglutide) from Novo Nordisk is seen as a game changer within the industry as it allows oral delivery of high molecular weight (>1300 MW) peptide delivery.

	This webcast will cover the physicochemical requirements for peptides and biological oral delivery barriers. Both aspects are crucial to de-risk pharmaceutical development and increase the success rate of first-in-human trials using innovative approaches.

		Understand physicochemical attributes of peptide for oral routes administration

		Review performance criteria for peptide formulation

		Learn about biological hurdles to overcome low oral bioavailability of formulated peptides

Dr. Hassan Benameur, Chief Scientific Officer Chemical Division, Lonza Pharma & Biotech

Wednesday, Apr. 1, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until Apr. 1, 2021

This webcast will cover physicochemical requirements and biological oral delivery barriers for peptides. Learn innovative approaches to derisk pharmaceutical development and increase the success rate of the first in human trials. 
Live: Wednesday, Apr. 1, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after airing until Apr. 1, 2021
Register free



Oral Peptide Delivery Utilizing Specialized Encapsulation Technologies

At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable biotech and pharma companies to bring large and small-molecule medicines to patients in need. From drug substance to the final drug product, our solutions feature concept to commercial capabilities to simplify your outsourcing experience and to provide a reliable outcome when you expect it. Together, we can bring your next medicine to life.


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Articles

At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable biotech and pharma companies to bring large and small-molecule medicines to patients in need.