Company Profile
Lyophilization Technology, Inc.
Company Overview
Lyophilization Technology, Inc. (LTI) was formed in January, 1992 as an organization to offer an extensive range of scientific services and technical support in freezing and freeze drying. Since its inception, the company has grown to provide a wide variety of services in diverse applications of the technology. These involve development of new products for clinical studies of novel therapies, transferring marketed products to multiple manufacturing sites, and streamlining operations coupled with improving regulatory compliance stature.
The mandates for the organization are to provide a source of services to industry that comprise development of new products, streamline manufacturing operations, and improve compliance with current regulations. The practical application of experience and expertise is coupled with interests in applied research and advancing the technology. This combination of research and commercial enterprise offers the industry a unique source of comprehensive expertise that spans from bringing a new product to market to increasing the productivity of existing operations.
SERVICES AND TECHNICAL SUPPORT:
Lyophilization Technology provides scientific services and technical support for the health care and related industries involved in producing pharmaceuticals, biologics, diagnostics, biopharmaceuticals, medical devices and fine chemicals. Scientific services consist of development, optimization and troubleshooting lyophilized products and processing. Such services may be provided using our laboratory facilities and when appropriate, on-site visits. Technical support includes consultation on equipment specifications, scale-up, validation, and compliance auditing. In-house training in fundamentals of the technology and validation are also available.
Successful collaborations involve small start-up companies to multi-national corporations. Projects span initial product and process development, technology transfer, gaining regulatory approval and commercial manufacturing. Clients and project sponsors realize numerous benefits from the focus on a comprehensive range of services in the technology.
Expertise in product design and process development for a wide variety of products:
Biologic and viral vaccines
Cells and cell cultures
Fibrous and globular natural and recombinant proteins
Monoclonal antibodies
Polypeptides
Small molecules
Experience and capabilities of unique products with extraordinary requirements:
Aqueous and organic solvents
Light and oxygen sensitivities
Physical structure and specific morphology
Success with projects focused on targeted objectives and aggressive schedules:
Novel therapies and routes of administration
Dosage form design for initial dose ranging studies
Overseeing small scale production of later phase clinical materials
Product transfer and process scale-up to commercial manufacturing
Increase productivity for commercial products and manufacturing processes:
Robust processes with increased control, productivity and yield
Improvements in process reproducibility and product consistency
Assessments of application of industry practices and regulatory compliance
Improved level of quality and compliance:
Resolution to equipment malfunctions and process excursions
Evaluation of process deviations and product failures
Support for preparing submissions and responses to regulatory observations
Method development for moisture testing and physical inspection standards
Greater in-house expertise through on-site training programs:
Customized for departmental groups and multidisciplinary staff
Principles and practical aspects of the science and technology
Workshops in product/process development and situation responses
Approaches and techniques for equipment qualification and process validation
STAFF QUALIFICATIONS AND EXPERIENCE:
These specially trained individuals utilize their formal education in basic and applied sciences to meet the challenges presented in product and process development and troubleshooting. These talented scientists and technicians form a cumulative multi-disciplinary background in the Sciences. Experience of the staff spans the pharmaceutical and medical device industries, as well as direct clinical settings. The staff also receives routine and extensive training in specialized areas that encompass analytical methods such as Thermal Analysis techniques, preparation of pharmaceutical and diagnostic products, with heavy emphasis on the science and technology of freeze drying.
ANALYTICAL, DEVELOPMENT AND PROCESS LABORATORIES:
Housed in a 10,000 square foot facility, these laboratories are well equipped for conducting a diverse range of experiments for product and process development as well as evaluating finished product attributes. The behavior during freezing and drying characterized using a uniquely designed freeze drying microscope and electrokinetic analysis. Capability for multiple methods of finished product testing include Coulometric Karl Fischer and Thermogravimetric moisture analysis.
Ease of scale-up is accomplished by completing process development studies within simulated manufacturing environment in the Process Lab. This small manufacturing lab can accommodate formulation, filtration, filling, lyophilization and packaging operations. A Qualified facility, with systems and equipment maintained within GMP compliance, is suitable for both development studies and preparing material for stability studies. Routine inspections by both study sponsors and independent auditors assure continually meeting a high level of compliance.
SCIENTIFIC PRESENTATIONS:
Numerous courses, papers, publications and poster sessions have been presented for societies and professional organizations, both within the United States and internationally. Some of the more recent presentations are listed below.
Publications:
• Low-Temperature Thermal Analyses are Key to Formulation Design, Thomas, M.; Cannon, A.J., Pharmaceutical Technology – Lyophilization 2004 Supplement: January 2004, pp. 21-49
• The Influence of Bottomed Trays on Sublimation Rates, Trappler, E.; Sunderland, W.; Gentilcore, T.F., Pharmaceutical Engineering: January/February 2004, pp.32-39
• The Influence of Lyophilization on the Polymorphic Behavior of Mannitol, Trappler, E.; Cannon, A. PDA Journal of Pharmaceutical Science and Technology: February 2000, pp 13-22
• Selecting and Qualifying an Alternate Heat Transfer Fluid for Lyophilizers: A Case Study, Trappler, E.; Manwaring,T. ISPE Pharmaceutical Engineering: November/December 1999, pp 64-72
• Assessing The Quality of Lyophilized Parenterals, Daukas, L.A.; Trappler, E Pharmaceutical & Cosmetic Quality: September/October 1998, pp 21-25
• Validation of Lyophilization The Key to Reproducibility and High-Quality Product, Trappler, E. IVD Technology: September 1995, pp 20-26
Presentations:
• Advances in Lyophilization: Systems and Facility Design (PDA)
• Performance Characteristics of Ready-to-Use Dessicant Closures, Day, Leslie; DeGrazio, F.L.; Drummond, J.L.; Hlobik, Tibor M.; Stokes, Jennifer R.; Trappler, Edward H. – Presented at PDA Conference in 2001
• Current Compliance Considerations for Lyophilization Process Development (AAPS)
• Development of a Lyophilization Cycle - Factors to Consider: A Case Study (AAPS)
• Effect of Stopper Design on Freeze Drying (w/ Smith & Currey, The West Co., PDA)
• Influence of Formulation Design on Lyophilization Processing Parameters (BioPharm)
• Influences of Formulation Design on the Behavior of Human Growth Hormone during Lyophilization: A Case Study (PDA)
• Lyophilization Overview (ISPE)
• Lyophilization Process Development: A Case Study (AAPS)
• Operation and Maintenance of Lyophilizers (PharmTech)
• Process Monitoring Using Residual Gas Analysis (PDA)
• Scaling up the Lyophilization Process (PharmTech)
• Techniques in Demonstrating Batch Uniformity for Lyophilized Products (PDA)
• Validation of Container/Closure Integrity for Vials Stoppered Under Vacuum (Freeze Drying of Pharmaceuticals and Biologicals) Presented at Freeze-Drying of Pharmaceuticals and Biologicals conference, Sep. 23-26/1998, Brownsville, VT, organized by CPPR.
• Validation of Lyophilization (Academy of Pharmaceutical Sciences & Technology, Japan)
• Validation of Lyophilization (MD&M)
• Validation of Lyophilization and FDA Issues and Concerns (Pharm. Tech)
• Validation of Paired Equipment: Freeze Drying (w/ Bender & Didas, Genentech, PDA)
Poster Sessions:
• Effects of the Vial on Sublimation Rates (w/ Ulfik, The Virtis Company, PDA)
• Effect of pH on Phase Transition Temperatures of Lyophilized Excipients (w/ Penner, Thomas Jefferson Medical College, PDA)
• Identification of Glass Vial Features Influencing Heat Transfer as Measured by Sublimation Rate Using a Placket-Burman Design (w/ Asselta, Comar, Freeze Drying of Pharmaceuticals and Biologicals)
• Influence of Vial Construction and Material on Uniformity of Product Temperature During Freezing and Freeze Drying of Model Product Formulations (w/ The West Company, PDA)
• Comparative Methods of Measurement and the Effect of Reduced Pressure on Seal Integrity for Lyophilized Products (PDA)
• Physical Strength of Materials for Pharmaceutical Vials and Prevention of Vial Breakage During Freezing and Freeze Drying (w/ The West Co., PDA)
Industry Sponsored Courses:
• Design and Operational Requirements of Freeze Drying Facilities for Pharmaceuticals
(w/ DeLuca, Fundamental Aspects for the Preservation of Sensitive Biologicals)
• Freeze Drying Workshop (w/ Nail, Bioprocess Separations Technology, American Society of Mechanical Engineers)
• Fundamentals of Freeze Drying (State Pharmaceutical Administration of China)
• Fundamentals of Lyophilization (PDA) & (w/ MacKenzie, Hull)
• Lyophilization of Parenterals and In-vitro Diagnostic Agents (Investigations Personnel Development Training Program, U.S. FDA)
• Lyophilization: Product Formulation, Process Operation and Validation (w/ Nail, PharmaNet)
• Lyophilization Technology Conference (w/ Bossert, Kiang, Nail & Pikal, IIR)
• Lyophilization Technology and Current Compliance Issues Seminar (Investigations Personnel Development Training Program, U.S. FDA)
• Lyophilization Theory & Practice (IPSE)
• Validation of Lyophilization (PDA)
• Aseptic Processing (PDA)
• Lyophilization Conference – in US and Europe (Barnett International)
Benefits
Compensation:
• Bi-weekly pay schedule
• Direct Deposit for payroll available
Performance Bonus Program:
• Qualify after one (1) year of full-time service
Holidays:
• 11 paid days each year (available after 3-month introductory period)
- 10 company scheduled days and 1 floating day, employee scheduled
Vacation Days:
• Up to 5 paid days accrued in 1st year (available after 3-month introductory period)
• 10 days accrued in 2nd year
• 1 day for each additional year of service
Personal/Sick Days:
• Up to 5 paid days accrued per year (available after 3-month introductory period)
Medical Insurance:
• 100% individual employee coverage
• Eligible after 3-month probationary period
• Medical: Independent Blue Cross, Personal Choice Flex PPO plan
- Doctor visits co-pay at $10
- Personal Choice Select Prescription plan co-pay at $5/10/25
- Optichoice, vision plan
• Dental: United Concordia, Concordia Preferred dental plan
Supplemental Insurance:
• AFLAC Flex-one®
- Optional employee funded plans through payroll deductions
- Menu of plans: short term disability, accident, major medical, term life insurance
- Eligible after 3-month probationary period
Retirement Plan:
• Simple IRA Retirement plan through Morgan Stanley
- Optional participation
- Employee directed contribution through pre-tax payroll deductions
- Participating employees qualify for company contribution
- Eligible upon next open enrollment period, to be advised
Professional Development:
• Training
- Hands-on job training with experienced, professional staff
- Detailed Standard Operating Procedures for methods and equipment
- Formalized training record system
- Target of two training courses/seminars per year
One professional and one personal development related
• Performance Evaluation
- Formalized performance review and professional development program
• Continued Education
- Tuition reimbursement including books, one course per semester