Formulation Development - Catalent Biologics

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Formulation Development

OVERVIEW

Technology & Methods

The formulation scientists at Catalent have experience in a variety of formulations and product presentations. The development team will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing a formulation that will ensure delivery of a stable product to the patient. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer. Whether your molecule requires a liquid or lyophilized formulation in a vial or syringe presentation, Catalent has the experience and capabilities needed to develop and deliver your clinical or commercial formulation.

TECHNOLOGY & METHODS

Dynamic light scattering
Multi-angle light scattering (MALS)
Analytical ultracentrifugation (AUC)
Differential scanning fluorimeter
Differential scanning calorimeter
Karl Fischer titration
Circular dichroism spectropolarimeter
Micro flow imaging
HIAC
Freeze dry microscope
Peristaltic and time pressure filler
LyoStar II lyophilizer

LyoStar II is a registered trademark of SP Industries Inc.

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FERDINAND HAMADA
DIRECTOR, BIOLOGICS, CATALENT RTP

Ferdinand Hamada is the Vice President of Information Technology supporting Catalent Biologics, providing IT partnership on the strategic direction and execution of digital transformation initiatives for the business unit. He spearheads the strategic planning process for IT, building out the digital transformational roadmap initiatives and forward-thinking by identifying innovation opportunities for automation, improvement of cost-effectiveness. Additionally, as the CISO, Ferdinand’s overall responsibilities for Catalent IT include Information Security, Risk Management & Compliance. He also heads up Computer Systems Validation, MDM/BI, Enterprise Architecture and Enterprise Applications for Quality & Compliance systems. Ferdinand’s main goal is to ensure IT is providing business value and meeting business objectives. He is responsible for execution of transformational roadmap initiatives including project delivery and deployment of technical solutions in support of those business objectives.

Ferdinand has been in IT in the Pharmaceutical/Life Sciences industry his whole career. Prior to joining Catalent in 2014, Ferdinand was in the Advisory consulting group for KPMG serving their top pharma clients. His responsibilities included overall planning and coordination, budgeting, execution and delivery on a global scale inclusive of oversight and quality assurance. Based on his industry experience, Ferdinand has a deep understanding of compliance and regulation around FDA, GxP, CSV, 21CFRPart 11, HCC/P, and Sarbanes-Oxley. Prior to KPMG, he also worked in different IT functions at Cardinal Health and Merck. Ferdinand went to Rutgers University for Computer Information Systems and Economics.

WIM BLENDEMAN
GENERAL MANAGER, BRUSSELS

Wim Blendeman serves as General Manager for Catalent’s European flagship syringe filling site in Brussels, Belgium. He has been with Catalent for nearly two decades, holding various leadership roles of increasing responsibility within Engineering, New Product Introduction, and Business Transformation. In addition to his breadth of knowledge of the Brussels site, Wim has extensive experience within Customer Excellence and Commercial Operations. He began his career in 1997 at Innogenetics in Manufacturing Operations and Development. Wim holds degrees in Pharmaceutical Sciences from the Catholic University College Ghent and in Mechanical Engineering from University College Ghent, as well as an MBA from Vlerick Business School.

BARBARA SAMBUCO
GENERAL MANAGER, ANAGNI

Barbara Sambuco is the General Manager of Catalent’s oral solid, sterile and biologic site in Anagni, Italy with more than 23 years of experience in product development, quality and operations. Ms. Sambuco joined Catalent following its acquisition of Anagni from Bristol-Myers Squibb. She spent 14 years with Bristol-Myers Squibb leading different teams within the site as the General Manager, Manufacturing Technology Director, QC Director and Operations Director. Prior to her time at the Anagni site she held leadership positions at Chiesi Farmaceutici, Hoechst and CTP, a pharmaceutical consultant company. Ms. Sambuco received her Bachelors in Chemistry and a Master in Biotechnology from the University of Rome “La Sapienza”.

MARIO GARGIULO
VICE PRESIDENT, OPERATIONS

Mario Gargiulo is the Vice President of Operations for Catalent Biologics, overseeing five manufacturing sites across the US and Europe. Mario has almost 30 years of technical and leadership experience in the pharmaceutical industry. Previously, he was the VP Operations for our Oral Delivery business. Mario joined Catalent in 2017 from Bristol-Myers Squibb where he worked for 12 years and covered roles of increasing responsibility up to VP Global Pharmaceutical Manufacturing where he was responsible for all the Pharmaceutical sites of the company. Prior to his time at BMS, Mario worked for Sanofi, Serono and Novartis in roles spanning from Operations, Quality and Supply Chain. A native of Italy, Mario earned a bachelor’s and master’s in Chemistry from the University “Federico II” of Naples.

THOMAS CASTELLANO
GLOBAL VICE PRESIDENT, OPERATIONAL FINANCE

Thomas Castellano is Global Vice President of Operational Finance for Catalent, Inc., supporting the company’s President & COO, and providing finance partnership on the strategic execution across the company’s business units. He is a member of Catalent’s Executive Leadership Team and the finance leader and business partner for the company’s Biologics business unit. Prior to this role, Tom was Vice President Finance, Investor Relations and Treasurer where he was responsible for optimizing the company’s capital structure and educating the investor base on Catalent’s growth story. Under Tom’s leadership, the company has raised more than $2 billion in the capital markets and doubled its enterprise value to more than $10 billion. He joined Catalent in 2008 to build out the company’s Financial Planning and Analysis group and played an integral role in the company’s initial public offering (IPO) in July 2014. His role expanded to include Investor Relations and Treasury immediately following the IPO.

Prior to joining Catalent in 2008, he worked with the capital markets finance group at Lehman Brothers, where he held roles of increasing responsibility. He began his career at Cendant Corporation as part of its financial leadership development program and was later promoted into the FP&A group of its real estate division. While at Cendant, he participated in the successful spin-off of Realogy Holdings Corporation in 2006.

Tom holds a bachelor’s degree in finance and an MBA, both from Seton Hall University.

MANJA BOERMAN, PH.D.
REGION PRESIDENT, BIOLOGICS, EUROPE

Manja Boerman is the Regional President for Catalent Biologics in Europe and has overall responsibility for strategy and management of the biologics business in Europe. Manja joined Catalent in December 2019. She has held several executive leadership positions at previous companies including President of Aesica Pharmaceuticals, President of Patheon Biologics, President of DSM Biologics and she served as CEO of biotech companies Kiadis Pharma and Regenesance. Manja started her career at DSM and held multiple business development and licensing and technology roles within DSM Biologics. She has over 20 years’ experience in the biotech and pharmaceutical industry and holds a PhD in Biochemistry from the State University of New York.

KAREN FLYNN
PRESIDENT, BIOLOGICS AND CHIEF COMMERCIAL OFFICER

Karen Flynn was named President, Biologics and Chief Commercial Officer in 2020. Prior to joining Catalent, she served as the Senior Vice President and Chief Commercial Officer of West Pharmaceutical Services, Inc. from 2016 to 2019, having previously served as that company’s President, Pharmaceutical Packaging Systems since 2014.

Ms. Flynn holds a Master of Science in Business Administration from Boston University, a Master of Science in Engineering from the University of Pennsylvania, and a Bachelor of Science in Pre-Professional Studies (Pre-Med) from the University of Notre Dame. She serves on the Chester County Economic Development Council Board of Directors and the Downingtown STEM Academy Advisory Board, and previously served on the Board of Directors for Recro Pharmaceuticals.

GEORGE BUCHMAN, PHD
VICE PRESIDENT, PRECLINICAL SERVICES AND PROCESS DEVELOPMENT

Dr. Buchman brings more than 25 years of highly cross-functional experience in the biotechnology industry to Paragon Gene Therapy, including roles in IVD R&D, leadership roles in manufacturing, fermentation and process development, global program management, business development and custom protein and VLP production.

Before joining Paragon in 2014, George spent 8 years at Chesapeake PERL (C-PERL) as Vice President of Operations and Chief Scientific Officer, primarily as Principal Investigator on multiple grants and contracts across a number of federal agencies, and as subcontractor to Prime Contractors for the custom production of proteins and VLPs. Prior to C-PERL, George worked for 5 years in global program management and business development roles at Celera Genomics and GeneLogic Corporation, both informatics businesses. He started in his post-doctoral career at Life Technologies, where he worked in a series of cross-functional roles and was a member of the Global Leadership team. George provided oversight for build-out of a cGMP-compliant protein production facility, and gained substantial experience directing groups in DNA and protein-related manufacturing and process development. George received his Bachelor of Science in Biochemistry from Albright College, and received his PhD in Biochemistry from the University of Maryland, College Park.

RANDY HENRICKSON
SENIOR VICE PRESIDENT, MANUFACTURING

Randy Henrickson has over 20 years of experience in site leadership, process development and technical support in the biotechnology field. His experience spans from early development to commercial launch of biological and vaccine products. During his career, he has worked for a variety of companies ranging from large pharmaceutical, start-up biotechnology, and contract manufacturing/development organizations (CDMO). Most recently, he was the SVP of Operations & Site Head at KBI Biopharma, a world-class CDMO. In this role, he led all aspects of site operations including business/client development. Before KBI Biopharma, he was the Director of Biological Tech Ops at Merck & Co., Inc. leading a development group that produced several clinical product candidates. He was also a Process Engineering Mgr at Insmed Therapeutic Proteins. Randy has a Masters of Chemical Engineering from Lehigh University and Bachelor of Science in Chemical Engineering from Purdue University.

RUBY HOFFMAN
SENIOR VICE PRESIDENT, HUMAN RESOURCES AND ORGANIZATIONAL DEVELOPMENT

Ruby Hofmann brings over 25 years of human resources experience to Paragon. Ruby is a dynamic HR Business leader with demonstrated success in creating business-driven HR strategies. Her passion is leading culture and talent transformational initiatives which result in fueling business growth.

Recognized for her business acumen and client-focused HR solutions, Ruby has had a successful career partnering with business leaders to create executable strategies leading to HR and Business Transformation. She has HR expertise in developing focused, results-oriented solutions that advance organizational performance, deliver a strong workforce, and develop exceptional leadership. She works with leaders to proactively identify change management opportunities and create plans to mitigate business risk.

She holds a Bachelor of Arts degree in Psychology from Hofstra University and a Masters of Science degree in Social Work from Columbia University.