Meridian Life Science, Inc.

Meridian Life Science,® Inc., (MLS)  is a premier provider of contract R&D, process development, and clinical cGMP biomanufacturing for vaccines, viral challenge materials, VLPs, gene therapies, and recombinant proteins in BEVS. With over 25 years of cell culture and virology experience, Meridian is the leader in Preclinical to Phase I cGMP manufacturing of viral based products.  MLS's business model involves highly collaborative R&D and process development designed to generate a robust and scalable manufacturing process for your product.   

Our Capabilities Include: 


Clinical (Phase I/II) Production of:

• Viral Vaccines:
• Recombinant, Live, Attenuated, Challenge
• VLPs, Oncolytic, and Therapeutic Vaccines
• Gene Therapy Vectors
• Recombinant Proteins (BEVS)

Excellence In:
• cGMP Cell and Virus Banking
• Cell Culture:
• Mammalian and Insect (BEVS)
• Egg-based Virus Production
• Process Development and Optimization
• Formulation and Fill

Superior Quality:
• Multiple Clean Rooms for Simultaneous Campaigns
• Proven cGMP Production (Phase I/II)
• Analytical Testing
• Mature Quality System
• CMC Regulatory Support

Some examples of our current projects include:

- Manufacture of a recombinant VLP vaccine (BEVS) to prevent parvovirus B19 infections in humans.  This vaccine consists of two viral proteins in separate bacuolvirus vectors which, upon co-infection and expression, self assemble into immunogenic virus like particles.   http://www.genengnews.com/articles/chitem.aspx?aid=3042#

- A contract with the NIAID of the NIH to manufacture 8 Phase I viral vaccines for RSV, PIV3, Dengue, and H1N1 influenza.

- Successful manufacture of a live oral Rotavirus Vaccine for PATH and Murdoch Children’s Research Institute.   

- Manufacture of RSV Memphis 37, a cGMP RSV challenge virus that has successfully been used in clinical studies and is available for R&D or clinical Use.   

- A contract to manufacture a dual VLP vaccine also manufactured in BEVS.

For more information please contact Daniel Shelly, PhD, at daniel.shelly@meridianlifescience.com or 513-272-5266

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Locations


United States
Memphis, TN

United States, North America

Contacts


Daniel Shelly, PhD, MBA
Director, Business Development

Production Lines

Memphis, TN   Viral Vaccine and Gene Therapy
United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 11NOV09

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Memphis, TN   Cell Culture Production Line
United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is Not AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 11NOV09

Send Inquiry about this Production Line

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