In the Know!

Welcome! Our goal is to provide you with industry updates on a routine basis. Each update of "In The Know" will bring you news of industry events, presentations, conferences, and educational information. 

We hope you enjoy Lyophilization Technology's (LTI) "In The Know." Look for our next update on the latest news!

LTI Recognized at the BCEDC 61st Annual Dinner and Meeting

LTI was recognized at the Bucks County Economic Development Corporation (BCEDC) meeting on April 11, 2019, at the Spring Mill Manor in Ivyland, Pennsylvania. Ed Trappler, President, was awarded a plaque in recognition of LTI's commitment to helping create and retain job opportunities in Bucks County through the continuing expansion with the support of the Pennsylvania Industrial Development Authority. He was joined by Paul Michele, Director of Business Affairs, and Christine Adams, Business Operations Manager.

LTI Welcomes
New Vice President of Business Development, Robert J. Cashman

Bob Cashman has joined LTI as Vice President of Business Development in April 2019 and is excited to be a part of the team. He is the key point of contact in both new business activities and continuing client relationships. He works closely with both the Management and Marketing teams, technical and manufacturing staff. Bob's primary role is introducing services available to LTI's existing and future clients.

Bob has more than 30 years of Business Development experience in the sterile product manufacturing sector of the pharmaceutical industry, including senior management positions at AMRI, OsoBio, Catalent, and West Pharmaceuticals. Mr. Cashman is well recognized within our industry, serving on the board of the Philadelphia Drug Exchange (PDE) as well as leading the Scholarship Committee for the Drug Chemical and Allied Trade (DCAT) organization. He holds a Bachelor of Science in Business Administration from Villanova University.

Robert J. Cashman
Vice President, Business Development

Leading Role in Clinical Manufacturing, Carrie A. Shults

Carrie Shults has assumed the leading role in the Clinical Manufacturing group. In heading the area, she is responsible for working with and providing guidance to the manufacturing staff and support to the Project Directors and Quality Assurance for the production of Toxicology, Phase I and Phase II Clinical Trial Materials. 

Carrie has over 20 years of professional experience in academia and the pharmaceutical industry. She began her career in the molecular biology field of pulmonary medicine as a research scientist. Before joining LTI, she held positions at Merck and GlaxoSmithKline. 

Carrie attended Neumann University, majoring in Biology and earned her Master of Science degree in Clinical Research from Drexel University. Carrie started her professional career at Children's Hospital of Philadelphia, with clinical work in pulmonary and cardiac units, at Fox Chase Cancer Center and the chondrocyte development labs at the University of Pennsylvania. Her experience in the industry includes cell culture and cryopreservation of cultures and cell lines at Merck and GlaxoSmithKline. She has been published in the Journal of Clinical Investigation, Journal of Allergy and Clinical Immunology, and American Journal of Physiology. She has authored and presented abstracts and poster presentations for society meetings. Carrie is a member of AAPS, ACS, ISL-FD, and PDA. 

She started at LTI as a Project Director in 2007, overseeing client projects. She was later promoted to Associate Director, Development Sciences responsible for scientific, technical, and quality oversight of all development activities.

Carrie A. Shults
Associate Director, Clinical Manufacturing

Recent Industry Contributions

"Combination Product Development - New Horizons in Development to Meet Emerging Demands"

Edward H. Trappler and John A. Merhige

This article is the result of a collaboration between Ed Trappler, of LTI, and John A. Merhige, of Credence MedSystems. 

The healthcare landscape has changed significantly throughout the past several years as the delivery of care has moved rapidly toward more economical and non-institutional settings. Just as many surgical procedures have moved from the hospital to the outpatient setting, the administration of injectable medications for chronic diseases has moved from formal healthcare settings to the home. This requires the product and delivery system to be conducive for non-healthcare professionals, self-injecting patients and friends or relatives to easily and successfully administer injectable medications. This is reflected in the projections for the self-injections market to grow more than 22% annually toward $119 billion by 2024. The course of therapy to treat chronic conditions is often an injected biologic, contributing to the forecasted growth for biologics of 10.9% CAGR to $480 billion in 2024. Many of these biologics, such as plasma proteins, vaccines, monoclonal antibodies, and oligonucleotides, as well as some small molecules, require lyophilization because they are unstable as aqueous solutions. The lyophilized dried form provides suitable preservation for adequate long-term storage, yet requires conversion into an aqueous solution at the point of care. Bringing such new products in unique presentations requires close collaboration between drug product development and device development professionals. Such collaboration during development, with continued alignment in the supply chain is essential to providing the patient a product that is effective as a therapy and suitable for proper and safe administration in the chosen care setting.

This article was published in Drug Development & Delivery in the October 2019, Volume 19, No. 7 issue.

"Destiny of the Particle"

Alison K. Mutchler, Associate Director, Science & Technology, LTI
International Society for Lyophilization and Freeze-Drying (ISL-FD) East Coast Conference
Gaithersburg, MD September 17, 2019

Inspection techniques for lyophilized parenteral products generally focus on the appearance of the dried cake and the container/closure. The absence of any particulate is also essential in meeting the requirements of a product for injection, as listed in the USP, Sections <1> and <788>. When it is assumed that particulates can be located anywhere in a lyophilized cake, the lack of complete visibility of any particulate material within a dried cake imposes specific challenges in the inspection of lyophilized materials.
To assess the effectiveness of physical inspection and the incidence of particulate detection, high contrast particles of varying sizes were placed into 10cc tubing vials filled with either 4% mannitol or 4% sucrose solution at a fill volume of 3.0mL. The samples were lyophilized, and subsequently, 100% inspected for physical appearance, presence, and location of the particulates utilizing various methods. Evaluating inspection techniques for detecting the presence of particles suggest that the use of the black/white background sequence for detecting stationary particles against a contrasting background, as in a lyophilized cake, is ineffective in identifying the presence of a contaminating particle.

"Collaboration in Supply Chain to Meet Emerging Demands for Injectable Drug Delivery"

John A. Merhige, Chief Commercial Officer, Credence MedSystems, Inc.
Michael S. Thomas, Senior Research Scientist, LTI
Partnership Opportunities in Drug Delivery (PODD)
Boston, MA October 7-8, 2019

A dual chamber reconstitution syringe is a prime example of a drug-device combination product with an intricate link between the device and the fill/finish process.  LTI and Credence are collaboration together and with select pharma manufacturers to advance the development of this innovative product.  


Upcoming Industry Events 

LTI wants to meet with you! Stop by our booths at any of the following events to discuss your lyophilization needs with one of our expert staff members. We look forward to meeting with you!

AAPS Pharm Sci 360
November 3-6 * San Antonio, Texas
Join AAPS for a meeting unlike any other!  AAPS PharmSci 360 combines all the energy of a large scientific conference with the intimacy of a niche meeting.  Each track is split equally between chemical  and biomolecule  areas, resulting in 10 sub-tracks  covering the research and challenges making the biggest headlines in the pharmaceutical sciences today. Please stop by booth 1203 for your lyophilization needs!!

PDA New England Dinner Meeting & Berkshire Facility Tour
November 13th * Lenox, MA
Join the PDA New England Chapter for a tour of Berkshire Sterile Manufacturing (BSM) in Lee, MA for an afternoon tour starting at 2:45 pm. Followed by an evening dinner, networking and a great opportunity to discuss key topics in Aseptic Processing with three leading industry experts. Please stop by our table for your lyophilization needs!!

For more events, visit our website!