PTK 2015 Banner 
2015 Peptalk M Banner 
2014 Archived Content

Cambridge Healthtech Institute’s Seventh Annual
Lyophilization and Emerging Drying Technologies
Formulation Development, Process Optimization, Validation and Regulatory Compliance
January 15-16, 2014


This annual conference covers the latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. It will feature in-depth case studies and discussion on developing a scientifically sound formulation, process optimization, vaccine and biologics freeze/thaw and formulation challenges, storage stability, strategies for scale-up from R&D to production, tech transfer and selection of container/closure systems.

Join with colleagues from around the world in this discussion of the key challenges and solutions in lyophilization and other drying technologies, and see how experts like you are developing a scientifically sound formulation to deliver a safe and stable biologic drug product.

Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

TUESDAY, JANUARY 14

1:30-2:00 pm Conference Registration



Buzz Sessions Green 2

2:00 BuzZ Session A (More Details >>)

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B (More Details >>)


4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses (SC8-SC14) More Details >> 


WEDNESDAY, JANUARY 15

7:30 am Conference Registration

8:00 Morning Coffee


Regulatory Guidance and commercial Considerations 

8:15 Chairperson’s Opening Remarks

David Cipolla, Ph.D., Senior Director, Pharmaceutical Sciences, Aradigm Corp.

Co-Chair:Robin Bogner, Ph.D., Associate Professor, School of Pharmacy, University of Connecticut


Keynote Presentation

8:20 Stabilization of Proteins by Freeze Drying: New Guidelines, or “Formulation and Process Heresy”

Michael PikalMichael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut

Commonly, “rules” for formulation and process design include the “command” to freeze dry below the Tg’ to insure product quality. Moreover, formulations should have very high Tg’s to insure good storage stability. These “rules” mean that more than trace levels of amorphous low Tg solutes or electrolytes should be avoided. However, recent data indicate that these rules can often be relaxed greatly without damage to critical quality attributes.


9:00 FDA Regulatory Requirements and Guidance for the Development and Marketing of Prefilled Syringes and Advanced Drug Delivery Devices

Michael GrossMichael Gross, Ph.D., Owner and Principal Consultant, Chimera Consulting North America

This presentation will consider recently issued FDA regulations and guidance for the development and marketing of drug delivery devices which are either indicated for, or co- packaged or prefilled with drugs and biological products. It will include good manufacturing practices, scientific and engineering information to be included in marketing applications and the reporting of manufacturing and design changes to approved applications.


Featured Presentation

9:30 Commercial Considerations that Drive Protein Device Combinations Strategies

Sesha NeervannanSesha Neervannan, Ph.D., Vice President, Pharmaceutical Development, Allergan, Inc.

This presentation will discuss the marketing and commercial considerations that are driving research and development of protein device combinations strategies.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


Lyophilized Formulation Development and Protein Stability 

10:45 Role of Water in Stability of Freeze-Dried Proteins: Practical Aspects and Mechanisms

Evgenyi ShalaevEvgenyi Shalaev, Ph.D., FAAPS, Research Investigator, Allergan, Inc.

Our ability to predict water impact on stability of freeze-dried proteins is rather limited, and the tolerable limits in the residual water content need to be tested empirically for any particular product. The presentation discusses approaches to reduce the empiricism in such studies, which include monitoring the physical state of the excipients, inhomogeneity in water distribution, molecular mobility, protein structure, and medium effects.

11:15 The Impact of Excipient State on the Structure and Stability of Lyophilized Biopharmaceuticals

Sean CullenSean Cullen, Development Scientist, Technical Development, Genzyme Ireland Ltd in collaboration with University College Cork

Excipient state is fundamental for maintaining protein structure upon lyophilization via glass dynamics and biochemical interactions. Data from our lab shows that using different lyophilization parameters renders excipients in different states which directly impacts protein structural integrity. Protein structural analysis performed in correlation with thermal analysis provides evidence of different stabilizing mechanisms of amorphous stabilizers.

11:45 Variation of Protein Stability with Ice Nucleation Temperature

Vamsi KVamsi Mudhivarthi, Ph.D., Postdoctoral Fellow, Pharmaceutical Sciences, University of Connecticut

The objective of this work is to determine the impact of annealing and ControLyoTM methods on sodium phosphate buffer crystallization and its effect on the stability of β-galactosidase. Studies were carried out on β-galactosidase in 5% sucrose, with a varied concentration (2–100 mM) of the phosphate buffer. The stability of the enzyme was determined by activity assay, HPLC, Fluorescence, and DLS.

SP Scientific12:15 pm Controlled Ice Nucleation in Production Scale GMP Lyophilizer

Shon_MarkMark Shon, MBA, Vice President, Technology Development, Technology Marketing, SP Scientific

 





Lam_PhilippePhilippe Lam, Ph.D., Senior Engineer, Pharmaceutical Processing & Technology Development, Genentech, Inc.

A 300 ft^2 GMP production lyophilizer was reversibly modified to enable control nucleation by the Praxair ControLyo TM Nucleation on Demand Technology. Freeze drying tests were conducted using several challenging formulations with high fill volumes and under aggressive drying conditions. The results confirmed that ControLyo TM Technology can yield lyophilizates that exhibit superior cake appearance and significantly tighter residual moisture distribution as compared with traditional non-forced nucleation cases.

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

INNOVATION IN EMERGING DRYING TECHNOLOGIES 

2:00 Chairperson’s Remarks

Satoshi Ohtake, Ph.D., Senior Principal Scientist, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

2:05 Current Status of Emerging Drying Technologies

Satoshi Ohtake, Ph.D., Senior Principal Scientist, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Traditional methods of commercial drying are limited either by their high production costs or severe loss in quality. Foam drying and spray drying technologies have been investigated in the context of processing pharmaceuticals. Some of the other technologies are still in its early phase of development, or have already been implemented and are common-place in other industries, such as food and waste treatment. Although direct application may not be feasible in their current form, it is of interest to understand the adaptability of these techniques for use in the pharmaceutical industry.

Bend Research 2:35 Development of a Room Temperature Stable Flu Vaccine Formulation Using Spray Drying

Breit_JefferyJeffrey Breit, Ph.D., Director, Pharmaceutical, Bend Research

A flu vaccine formulation was developed using spray drying and has been exposed to and shown stability at 50 degrees Celsius for multiple months. This program was performed in collaboration with PATH and Fraunhofer. The talk will highlight the formulation development and spray drying process that went into the creation of a novel flu vaccine. The results of a long-term stability study will highlight the quality of the formulation and the spray dry process used to develop the vaccine.


Modeling in Lyophilization Process Development 

3:05 Toward System-Level Modeling and Control of Freeze-Drying Process Dynamics

Arnab GangulyArnab Ganguly, Ph.D. Candidate, School of Aeronautics and Astronautics, Purdue University

Successful lyophilization requires controlled, low-pressure environment for heat transfer, vapor sublimation, transport and condensation. The process dynamics involves a complex interplay of many design parameters, including those related to product formulation, container-closure system, freeze-dryer capability and operating conditions. Here we present a system-level simulation framework coupling equipment and process design to product attributes via first-principles based models and measurements. Equipment and process modifications to increase throughput and efficiency are considered.

Millrock3:35 LyoPAT - True PAT for Freezing and Primary Drying

Thompson_TNT.N. Thompson, President, Millrock Technology, Inc.

Monitoring and control of both the freezing and primary drying phases is now possible with recent innovations. The result is a more consistent quality product processed in less time.

 

3:50 Refreshment Break

4:15 A Simplified Experimental and FEM Approach for Lyophilization Scale-Up

Vikram Sadineni, Ph.D., Senior Research Investigator, Drug Product Science and Technology, Bristol-Myers Squibb Co.

Commercializing a robust lyophilized product involves an efficient transfer of process parameters that are developed at lab scale and is often accomplished by costly engineering runs at commercial scale. Here, we are highlighting a combination of experimental and finite element modeling (FEM) approach to predict commercial process parameters for primary drying phase, often the product quality and time critical phase, of lyophilization. The proposed approach offers a simple, less capital and time intensive strategy for a robust lyophilization scale-up.

4:45 Mathematical Modeling of Lyophilization Process – How Can it Help Robust Process Development While Reducing Development Timelines?

Venkat KogantiVenkat R. Koganti, Ph.D., MBA, Associate Director, Formulation & Process Development, Celsion Corp.

Even though conceptually lyophilization is a classic heat and mass transfer problem, it is underutilized in routine cycle development and technology transfer. This presentation will provide and an overview of different approaches to modeling the lyophilization process while providing case studies of utilizing modeling in areas ranging from initial cycle development to defining design space for regulatory filings.

5:15-6:30 Reception in the Exhibit Hall with Poster Viewing



Day 1 | Day 2 | Download Development Brochure | Speaker Biographies