Pharmaceutical Engineering: At the Frontier of Drug Substance and Drug Product

An ECI Conference

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Postponed
Boulder, Colorado

About This Conference

It is well known that the physical and chemical properties of the DS (API) have major impacts on the formulation and the Drug Product (DP) process. In any dosage form including solid, liquid and semi-solid, the Drug Substance (DS) or Active Pharmaceutical Ingredient (API) goes through a formulation process. This process to make the final drug product serves many purposes, but all with the goal of eventually delivering the active ingredient to the desired sites in the patients’ body in the most convenient way and to achieve optimal therapeutic effect. 

For most small molecule drugs, the final step in an arduous synthetic sequence is usually the crystallization or precipitation of the DS. This serves as both an isolation as well as purification step. In addition, many particle engineering techniques have been advanced that can tailor the physical and chemical properties of the drug substance during the final step in order to facilitate the design and scaleup of a rugged and reproducible DP processes. From historical and regulatory viewpoints, the blurring of the DS/DP interface while having the potential to offer competitive advantages, there will be regulatory and cultural hurdles that need to be ameliorated. The impact of DS properties on DP performance and the DP processes have attracted wide interest in the industry. However, many engineering issues and mechanistic understanding concerning the DS, the formulation, and their interface still need to be developed and explored. This conference seeks to bring scientists, engineers and regulators working at this critical interface for mutual discussion of current results, future improvement and to identify any technical and regulatory needs that still exist. Participants attending this conference will significantly benefit from learning the innovations from the integration of DS (API) and the formulation of the drug product.

Conference Program Themes 

• Role of particle engineering
• Material science of API/DS and formulation -Impact on drug product performance and process scaleup
• Pharmaceutical composite materials

Conference Program

Program coming soon

Conference Organization

Conference Chair

San Kiang, CTO J-star/Porton Pharmatech LTD., USA

Conference Co-Chairs

Kaushalendra Chaturvedi, J-Star Research
Tianyi Li, J-Star Research 

Organizing Committee

• Deniz Erdemir, BMS, USA
• Mauricio Futran, Janssen, USA
• Junbo Gong, Tianjin University, China
• Ren Guobin, East China University of Science and Technology, China
• Soojin Kim, Hanmi Pharmaceutical Co., South Korea
• Alfred Lee, Merck & Company Inc., USA
• Allan Myerson, Massachusetts Institute of Technology, USA
• Srividya Ramakrishnan, Dr. Reddy’s Laboratories, India
• Vidya Swaminathan, AstraZeneca, UK
• Bing-Shiou Yang, Boehringer Ingelheim Pharmaceuticals, Inc., USA

Invited Speakers

Material Science Session

Simon J. L. Billinge

Professor of Materials Science and Engineering and Applied Physics and Applied Mathematics, Columbia University

Research Areas:
Amorphous and nanostructured pharmaceuticals and molecular materials, methods for solving the nanostructure problem, nanoscale fluctuations in exotic electronic materials, nanostructured materials for energy and environmental remediation, software for complex modeling and nanostructure determination

Title of Presentation:
Advanced X-Ray Analysis of Disordered and Composite Materials

Boris Rybtchinski

Associate Professor, Department of Organic Chemistry Weizmann Institute of Science

Research Areas:
Supramolecular chemistry, crystallization mechanisms, sustainable and energy materials, as well as electron microscopy

Title of Presentation:
Imaging Organic and Protein Crystallization Mechanisms

Clare Strachan

Associate Professor, School of Pharmacy University of Helsinki

Research Areas:
The physicochemical characterisation and optimisation of solid drugs and dosage forms

Title of Presentation:
Application of Non-Linear Imaging and Spectroscopy to Engineered Particles

Christian Serre

Research Director, Centre National de la Recherche Scientifique
Organization: Institut des Matériaux Poreux de Paris

Research Areas:
Synthesis, structure determination, including the use of X-ray diffraction data, and applications related to health, environment and energy of porous stable and functional porous solids (Metal Organic frameworks…)

Title of Presentation:
Porous Biocompatible Metal Organic Frameworks in Biomedicine

David Lechuga-Ballesteros

Research Fellow PT&D, Inhalation Product Development
Organization: AstraZeneca Pharmaceuticals LP

Research Areas:
Pharmaceutical materials science

Title of Presentation:
The Relevance of Pharmaceutical Material Sciences in the Development of Inhaled Biologics

Sven L. M. Schroeder

Professor, Leeds University

Research Areas:
nanoscience; analytical science; physical chemistry; surfaces; crystallisation; catalysis; wastewater; formulation; interfaces; colloids; synchrotron radiation; X-ray; spectroscopy; microscopy

Title of Presentation:
MONITORING OF CRYSTALLIZATION PROCESSES WITH REAL-TIME X-RAY PHASE-CONTRAST IMAGING (XPCI) AND COMPLEMENTARY ADVANCED X-RAY ANALYSIS

Particle Technology Session

Christopher Burcham

Senior Engineering Advisor, Eli Lilly and Company

Research Areas:
Pharmaceutical Process Development with an emphasis on Crystallization and particle formation process design; mechanistic modeling

Title of Presentation:
Examples of Particle Engineering to Improve Patient Outcomes and Product Manufacturing

Marco Mazzotti

Prof. Dr. Dr. h.c., ETH Zurich

Research Areas:
Crystallization, Carbon Dioxide Capture and Storage systems

Title of Presentation:
SIZE AND SHAPE ENGINEERING OF NEEDLE-LIKE CRYSTALS

Allan S. Myerson

Professor, Massachusetts Institute of Technology

Research Areas:
Crystallization, pharmaceutical manufacturing

Title of Presentation:
CONTINUOUS CRYSTALLIZATION AND PURIFICATION: THE ROLE OF IMPURITY INCORPORATION MECHANISMS IN NON-EQUILIBRIUM  PROCESSES

Zoltan K Nagy

Professor of Chemical Engineering, Purdue University

Research Areas:
Crystallization and particulate systems engineering, Process Systems Engineering, Process Intensification and Control, Advanced pharmaceutical manufacturing

Title of Presentation:
Novel Process Intensification Approaches to Integrate Drug Substance and Drug Product Manufacturing

Jian Wang

VP, Center for Pharma Crystallization, J-Star Research, Inc.

Research Areas:
Crystallization Process R&D
Polymorph Discovery & Studies
Pre/Early Formulation Evaluation
DS-DP Co-Processing

Title of Presentation:
Bridging the Gap between API and Drug Product via Coprocessing

Dr. Fredrik L. Nordstrom

Senior Research Fellow, Boehringer Ingelheim

Research Areas:
Isolation development, polymorphism and impurity purge mechanisms relevant to pharmaceutical applications

Title of Presentation:
Root-cause analysis across the DS-DP interface in the pharmaceutical development and manufacturing

Composite Material Session

Deniz Erdemir

Principal Scientist, Bristol-Myers Squibb

Research Areas:
Dr. Erdemir’s research focus lies at the drug substance-drug product interface with emphasis on crystal polymorphism and design of materials via particle engineering to enable robust drug products

Title of Presentation:
CO-PROCESSING METHODOLOGIES TO IMPROVE POWDER PROPERTIES OF DRUG SUBSTANCES

Saif A. Khan

Associate Professor, Chemical and Biomolecular Engineering, National University of Singapore

Research Areas:
Continuous Pharmaceutical and Materials Manufacturing, Microfluidics, Flow Chemistry, Particle Engineering

Title of Presentation:
DRUG PARTICLE ENGINEERING USING MICROFLUIDIC EMULSION-BASED CRYSTALLIZATION

Korbinian Löbmann

Associate Professor, University of Copenhagen

Research Areas:
My research background lies in solid drug formulation and physico-chemical characterization thereof. This includes in particular the development of new enabling formulation strategies, such as amorphous solid dispersions containing proteins as stabilizers, co-amorphous drug delivery systems, and microwave amorphization (in situ amorphization); as well as novel excipients, such as mesoporous silica or cellulose nanofibers

Title of Presentation:
Co-amorphous systems and multicomponent amorphous mixtures

Changquan Calvin Sun

Director of Graduate Studies, Professor, Department of Pharmaceutics, University of Minnesota

Research Areas:
Pharmaceutical Materials Science, Powder Technology, Solid-state Science, Crystal engineering

Title of Presentation:
Challenges and opportunities in optimizing mechanical properties of drugs by incorporating excipients

Rajesh N Davé

Distinguished Professor, Ph.D. , New Jersey Institute of Technology

Research Areas:
Particle Engineering, direct compression formulations, engineered excipients, drug nano-composites, polymer film coating of fine particles, dry coating, thin films for pediatric/geriatric drug delivery

Title of Presentation:
Predictively Enhancing Bulk Properties of Cohesive Pharmaceutical Powders

Patrick Doyle

Robert T. Haslam, Professor of Chemical Engineering, MIT

Research Areas:
Microfluidics, soft matter, biophysics

Title of Presentation:
New API formulations enabled by soft matter concepts

Special Topic Session

Huiquan Wu, Research Chemical Engineer, Division of Manufacturing Assessment I (DMA I), Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Research Areas
Pharmaceutical Manufacturing Process Understanding and In-Process Control, Process Analytical Technology (PAT) and its Pharmaceutical Applications, Manufacturing Process Engineering and Integration Assessment

Title of Presentation
Critical Pharmaceutical Manufacturing Process Challenges and Opportunities with Illustrations from Scientific Research Case Studies

Abstract Submission

Abstracts should be submitted as soon as possible and no later than the deadlines noted below.  The abstract should consist of 5 parts:  Purpose, method, results, conclusion, and reference.  The abstract should introduce the proposed paper’s subject, summarize its contents, explain any unique aspects, and clearly indicate the specific relevance to the themes of the conference.  

Please prepare your abstract according to this template: docx or doc.

All abstracts should be submitted electronically HERE.

Oral abstract submission deadline: March 15, 2022

Poster abstract submission deadline: March 15, 2022

Only a limited number of oral presentation slots are available and thus all submissions for oral sessions will be considered for both oral and poster presentation.

Abstracts of all presentations will be made available to conference participants prior to the start of the conference.

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, Tuesday and nights), all meals (with the exception of Monday dinner)from Sunday evening dinner and reception through Wednesday lunch, taxes, and gratuities. Incidental fees (telephone calls, faxes, laundry, etc.) are billed to your personal account by the hotel.  

ALL PARTICIPANTS (INCLUDING MEMBERS OF THE ORGANIZING COMMITTEE AND INVITED SPEAKERS) ARE REQUIRED TO REGISTER.

The conference fees are:

	Register on or before April 17, 2022	Register after April 17, 2022
Participant (single occupancy or sharing room with a guest; guest fee additional)	US $2,260.00	US $2,460.00
Participant (sharing a room with another participant)	US $1,915.00	US $2,115.00
Bona fide Graduate Student (sharing a room with another student) (Those in this category must send proof of current status – copy of current Student ID can be faxed to 1-212-514-6030 or emailed to Kathy@engconfintl.org)	US $1,600.00	US $1,800.00
**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (Includes all conference included meals)	Contact K. Chan	Contact K. Chan

If you plan to bring children to the conference, please contact Kathy (kathy@engconfintl.org) for pricing.

Conference Registration

You will need a login name and password to register for ECI conferences through our online system. If you have been a recent participant at an ECI conference or have submitted an online application or request for information about an ECI Conference, you may already have an account with us. If you know your login information, please use it. 

If you are not sure whether you already have a login and password, please click on automated password retrieval and enter your e-mail address before creating a new account. If we don’t have a valid email address on file for you, a pop up window will appear stating that no records were found. Click “OK” and then follow the instructions to create a new account. 
If you have any questions or experience any difficulties, please email kathy@engconfintl.org.

Special Notes and Payment Instructions

We suggest that you register as soon as possible to be certain that you will have a hotel room at the conference rate.  

All participants are encouraged to register before April 17, 2022.  There is a discounted price for registering before this date.  Hotel space cannot be guaranteed for registrations received after this date.  Your registration is not officially confirmed until we receive payment of the amount due and COVID-19 vaccination proof is verified by ECI staff.  ECI reserves the right to cancel your room registration if payment is not received or your vaccination proof is invalid. Your invoice/receipt will automatically be e-mailed upon of receipt of your registration.  Should you need a signed receipt, please contact Kathy Chan (kathy@engconfintl.org).

Because of contractual guarantees made with the hotel for room and meal functions, no shows, late arrivals, missed meals and early departures cannot receive fee adjustments.  If you have a disability and may require accommodation in order to participate fully in this conference, please indicate this when you register. An ECI representative will contact you to discuss your specific needs. If you have special dietary requirements (e.g., vegetarian or a food allergy), please make a note on your registration.  The chef needs to know this information in advance if we are to accommodate you. ECI will attempt to accommodate special requests such as Kosher or Halal meals, but such meals may not be available at all conference sites. The participant must pay any additional costs for special meal requests to ECI.

Payment must be made by credit card (Visa, MasterCard, and Amex), check or money order drawn on a U.S. bank in U.S. dollars, payable to ENGINEERING CONFERENCES INTERNATIONAL. Checks or money orders in any other currencies are NOT ACCEPTABLE.  Payment must be made on the web site except for those who are sending payment by wire transfer or have a purchase order from their company/institution. 

WIRE TRANSFER PAYMENT: If you are planning to make payment by wire transfer, please contact ECI for the bank information. You must add $30 to cover ECI bank charges. Please reference your full name and the conference title.  Either fax a copy of your bank transfer papers to ECI (Fax: +1-212-514-6030) or email a scanned copy to kathy@engconfintl.org.  This is very important – otherwise it is extremely difficult to trace your payment and you may not receive a receipt prior to the conference.

Cancellation Policy: Cancellation must be received by ECI in writing at least 28 days prior to the start of the conference in order for a full refund (less a processing fee) to be considered. The ECI auditors require that refunds for all conference cancellations be processed after the conference so that the necessary back-up information (e.g., hotel list of those in-house) can be attached to the refund request and ECI can verify that the hotel has not charged a cancellation fee. 

Cancellation fees:

• Cancellations received more than 28 days prior to the conference start date are subject to a processing fee of 4% of the total fee, plus any direct expenses incurred by ECI. 
• Cancellations received 15 – 28 days prior to the conference start date are subject to a $250 cancellation fee plus any direct expenses incurred by ECI. 
• Cancellations received 8 – 14 days prior to the conference start date are subject to a $500 cancellation fee plus any direct expenses incurred by ECI. 
• No refunds will be issued for cancellations received less than 7 days prior to the conference start date. 
• No refunds will be issued due to inclement weather or travel disruptions/cancellations.

Registrations may be transferred without incurring any penalty or cancellation fee.

Denied or delayed visa

If a participant is forced to cancel due to a denied or delayed entry visa, ECI will issue a full refund if ECI has been notified of a potential visa issue at least four weeks prior to the conference start date.

Change of payment method

If an attendee who has already paid the conference fee with a credit card requests that the fee be refunded to that card so that it can be paid in a different manner (e.g., charged to an alternate credit card, or paid via check or bank transfer), a processing fee of 4% of the total fee amount will apply.

Disclaimer

It may be necessary for reasons beyond the control of ECI to alter the content and timing of the program or the identity of the speakers. In the unfortunate circumstance that an event is cancelled, ECI is not liable for any costs incurred by participants in connection with their attendance.

Smoking is prohibited at ECI conferences and conference functions.  

Should you have specific questions regarding your registration, please contact Kathy Chan (Kathy@engconfintl.org). 

Conference Sponsors

Sponsorship Levels

General Information about ECI

Engineering Conferences International (ECI) is a not-for-profit, global engineering conferences program, originally established in 1962 that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

The format of the conference provides morning and late afternoon or evening sessions in which major presentations are made. Poster sessions will be scheduled for evening discussion as well. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. This format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

All participants are expected both to attend the entire conference and to contribute actively to the discussions. The recording/photographing of lectures and presentations is forbidden. As ECI conferences take place in an informal atmosphere, casual clothing is the usual attire.

Smoking is prohibited at ECI conferences and conference functions.