Articles & Presentations

What's New

Environmental Monitoring Programs

TLI Development recently completed an extensive restructuring of an environmental monitoring (EM) program in conjunction with Cleanroom Management.  The program changes followed a major facility renovation to the heating, ventilation, and air conditioning (HVAC) system.  From site selection to HEPA filter integrity testing to establishing an electronic database for rapid monitoring of EM data, we provided a highly integrated package.  Please contact us to learn more about how you can apply these cutting edge principles to your program. 

Biosimilars Update

COMING SOON: 

Latest legislative initiatives in the US Congress regarding biosimilar proposals and how this could shape the industry.

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Biologics Development

Biologics development has some unique milestones and regulatory compliance aspects.  Some in-depth reviews of these areas are outlined in the following presentations.  

• Regulatory Affairs for Biotech:  Critical Steps for Compliance (training course)
  • Regulatory Oversight & Feedback in Biotech Development
  • Production & Scale-up:  Key Features of Manufacturing Process Development
  • Comparability Studies for Process Changes and Multisource Biotech
  • Analytical Techniques:  Strengths & Limitations
  • Assessing Risk and Uncertainty in Biotech Development
  • Current & Future Technology Applications in Biotech
• Analytical Equivalence:  Overview of Testing for Various Product Classes
• Demonstrating Therapeutic Equivalence of Biotech-derived Products:  Correlation of Structure-Activity Relationships (SAR) to Clinical Safety and Efficacy
• Manufacturing Related Issues in Biotech Development
• Analytical, Bioequivalence, & Surrogate Endpoint Equivalence
• Specifications & Manufacturing Control:   A Prototypic System for Electronic Document Tracking & Management
  • 2002 DIA Electronic Data Management (EDM) presentation (Philadelphia, PA), which was the basis for an article in BioPharm (March 2002) by the same name

Biosimilars & Follow-on Biologics

Provided below are presentations, articles, legislative summaries, links to other sites, and much more.  Some key documents include:  

• Multisource Biologics:  Demonstrating Therapeutic Equivalence of  Biotech-derived Products

     IIR International Generics Strategy:  Pre-Conference Symposium on Comparable Biotech Products (May 22, 2002) (Barcelona, Spain)

   

• Points to Consider for the Multisource Biotech Initiative in the US:  Comparability vs. Therapeutically Equivalent

     40th Annual Drug Information Association (DIA) Meeting; Session on Regulatory and Development Considerations for Multisource Biotech (June 2004)

   

• Demonstrating Therapeutic Equivalence of Biotech-derived Products:  Correlation of Structure-Activity Relationships (SAR) to Clinical Safety & Efficacy

     Management Forum:  Comparability Issues in the Development of Biotechnology Products ... and Consideration of Biotech Generics (October 25, 2002) (London, UK)

   

• Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-derived Pharmaceuticals

  Drug Information Journal, Vol 34; 919-959, 2000

Controlled Substances

This section contains presentations regarding controlled substances compliance, audit checklists, and more.  Note that these presentations are from a seminar course last taught in 2002 so some of the regulatory aspects have changed, such corporate recordkeeping and legislative overview.  Some key documents include:  

• Controlled Substances:  Compliance Issues and Practices for the Pharmaceutical Industry
  • Overview
  • Analytical Registrants
  • Manufacturer's Overview
  • Internal Audits
  • Import/Export
  • Controlled Substances Legislation Overview
  • Corporate Recordkeeping
  • Roundtable Discussion:  Compliance Questions
• CS Audit Checklist (Note that this checklist was last updated in 2005 so there may be regulatory changes that need to be included.)