Services

Sierra Vista Biotech Consulting can provide the following services.

Process Development Consulting:

   ◊  End-in-Mind definition  
   ◊  Commercialization goals definition
   ◊  Process development strategy definition

   ◊  Upstream

       •  Cell culture characterization and optimization
       •  Fermentation characterization and optimization
       •  Isolation characterization and optimization- product
                 collection and clarification, soluble and inclusion bodies

     Downstream
       •  Process design, characterization, and optimization
       •  Chromatography
       •  Tangential flow filtration
              •  Concentration
                Diafiltration
         Process chemistry- refolding, derivatization, enzymatic
                 modification
         Process removal characterization and optimization
         Intermediate characterization and optimization

     Analytical
         Methods development and evaluation

     Quality
         Laboratory equipment qualification
         Standard operating procedure preparation and evaluation
         Technical report evaluation and preparation


Commercialization and Manufacturing Consulting:

     Manufacturing strategy definition
     CMO evaluation
     Technical Transfer, internal and external
     Facility and infrastructure design
     Equipment evaluation

     Manufacturing:
         Start-up planning, initiation
         Problem solving, trouble-shooting
         Continuous improvement activities, SPC, etc.

     Regulatory
         NDA/BLA preparation, Common Technical Document (CTD)
               module preparation
         Late phase development studies for CTD/NDA/BLA
               preparation
         Interactions with regulatory agencies

     Quality
         Validation support, protocol preparation and evaluation, data
               analysis and report preparation and evaluation
         Standard operating procedure preparation and evaluation
         Batch record preparation and evaluation

      

Training Seminars/Courses/Lectures:

      1.  Introduction to the Biotech Industry
           a.  Biotechnology
           b.  BioProcess Economics
           c.  Quality by Design

      2.  Introduction to Processes, Processing and Equipment
           a.  Proteins
           b.  Upstream Processing
           c.  Processing

      3.  Introduction to Process Development
           a.  Biotechnology Process Development
           b.  Upstream Process Development
           c.  Downstream Process Development
           d.  Continuous Improvement
           e. BioProcess Technical Transfer
           f.   Process Analytical Technology (PAT)
           g.  Common Technical Document (CTD)

      4.  Advanced Processes, Processing and Equipment
           a.  Chromatography
           b.  Scale-up of Chromatography

      5.  Advanced Process Development
           a.  Upstream Process Development
           b.  Downstream Process Development
           c.  Continuous Improvement
           d.  Common Technical Document (CTD)

       6.  Workshops
           a.  Process Development Workshop
           b. Continuous Improvement Workshop


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