Lyophilization Technology, Inc.
30 Indian Drive
Ivyland, PA 18974-1431
T: (215) 396-8373
F: (215) 396-8375
E: inquiry@lyo-t.com
W: www.lyotechnology.com


WHO WE ARE

Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization of health care products.

Clients leverage on our abilities for bringing new products to the clinic and implementing improvements for current products and processes. Capitalize on over 30 years of excellence and our unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

MAJOR MARKETS

Biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations, along with universities and research institutes have engaged our services in successful collaborations for a variety of projects. These projects span initial product design and process engineering for new entities right out of drug discovery through Phase 1/2 clinical supplies, to technology transfer to commercial manufacturing with regulatory approval. Gaining a global reputation, LTI has been sought after and completed projects with clients in the European, Middle East, and Asian Pacific regions, as well as Canada and the Americas.

SERVICES OFFERED

Capabilities

  • Pre-clinical through Phase II Clinical Supplies
  • Bulk Lyophilization
  • Dedicated/disposable equipment
  • Batch sizes: up to 75L
  • Vials: 2 to 160 mL
  • Dual Chamber cartridges and syringes: 1 to 20 mL
  • Novel delivery systems
  • Nucleation On-Demand Technology
  • DEA license
  • US/EU compliant

LTI successfully develops formulations, processes or prepared clinical material for many diverse products, including:

  • Biologics (up to BSL-2)
  • Oncolytics
  • Liposomes
  • Anti-Infectives
  • Peptides/Polypeptides
  • Proteins/mAbs
  • Diagnostics
  • Nanoparticles/Emulsions
  • Vaccines and VLPs
  • Controlled Substances
  • Highly Potent Compounds
  • Antibody Drug Conjugates
  • Devices/Delivery Systems
  • Small and Large Molecules

Development Sciences

Development Sciences focuses on initial product design and formulation development through finished product characterization. The Process Lab provides capacity for small to medium scale lyophilization. Filtration, filling, stoppering, and loading the qualified pilot-scale lyophilizers are in certified Class A/100 environments, emulating aseptic manufacturing conditions.

  • Product Design
  • Formulation Development
  • Thermal Analysis
  • Process Engineering (Cycle Design)/Refinement
  • Product Characterization
  • Pilot Plant Scale-up
  • Isolation/Containment
  • Cartridges/Syringes/Dual Chamber Devices

Clinical Supplies Manufacturing

US/EU compliant Clinical Manufacturing Area (CMA) for preparation of clinical supplies enable us to process a wide range of products, including those having unique requirements. The CMA includes an aseptic suite featuring advanced containment/isolation technology using unique disposable negative pressure isolators inspected and approved for handling BSL-2, cytotoxic and highly potent compounds. LTI has also developed the technology that allows us to freeze dry product in both dual chamber cartridges, syringes, and dual chamber devices.

  • Aseptic compounding
  • Pre-clinical through Phase II
  • Toxicology Material Processing
  • Small to medium batch sizes
  • Liquid/diluents
  • All Dual chamber devices

Technical Services

Technical services are available providing support for all aspects of lyophilization.

  • Customized Training
  • Consulting on equipment specifications
  • Process requirements
  • Guidance on CMC submission
  • Support on IQ/OQ and process validation
  • Technology transfer
  • Process excursions
  • Product and process troubleshooting
  • Batch record review
  • Compliance auditing