Typical
Deliverables

 

Venetas provides individualised technical and management solutions that cover the whole spectrum of vaccine development from concept to consumer

 

Scroll down to see typical packages that are customised to your specific needs

Or find specifics using the links below

Vaccine Development | Vaccine Facility | Technical Support | Documentation | Interim Management | Project Management

image of a person engineering a vaccine

Multi-Disciplinary

Packages

 

Scientific Package - Vaccine Development

  • Business plans and integrated Product Development Plans, including review of existing plan(s)

  • Vaccine process design from gene to drug product in final container

  • Dose/dosage form selection and drug substance/drug product specifications

  • Preclinical/proof-of-concept plan development in animal model(s)

  • Regulatory document drafting, preparation and submission

  • Clinical development plan

 
 

Engineering Package - Vaccine Facility

  • Users requirements’ specification (URS) document

  • Concept Study (CS) or Front End Engineering Design (FEED)

  • CapEx and OpEx estimates

  • Engineering design and selection of construction company

  • Represent client during facility construction

  • Support facility qualification (IQ/OQ), validation (PQ) and (cGMP) accreditation

  • Support staff recruitment, training, facility start-up and operation

  • Support process performance qualification (PPQ) batches and product licencing

 
image of a person in business discussions

Single-Disciplinary

Packages

 

Technical Support

  • Product yield review and optimal expression system selection

  • Cell culture process development including equipment, culture components and improvements (e.g. by fed-batch) and alternative methods of product extraction/solubilisation

  • Purification process development including affinity chromatography, virus inactivation/removal steps and step-yield improvements (e.g. by resin change, extended washing, etc.)

  • Optimal excipient selection for drug formulation

  • Optimal drug product container, closure and seal selection

 
 

 Documentation

  • Business plans and presentations to potential investors

  • Site master files, drug master files and users’ requirements documents

  • Draft contracts (R&D, tech-transfer etc.)

  • CTA/IND(A) for clinical trials submission to regulatory authorities

  • Quality statements, SOPs and batch manufacturing records

  • Stability studies, QC specifications and QA release criteria

  • GMP-grade facility equipment lists and operating cost estimates

  • GMP-grade facility layout, design, and capital cost estimates

  • Concept studies leading to front end studies & cost estimates

  • Registration of manufacturing facilities with regulatory authorities

  • Request for Proposals (RfPs)

 
 

Interim Management Leadership

  • Manage R&D scientists, process engineers and/or cGMP manufacturing staff

  • Temporarily replace executives and integrate new hires

  • Build new scientific/engineering teams and/or re-structure existing ones

  • Manage strategic capital investment and consolidate existing capital assets

  • Coach scientists/engineers for continuous professional development

 
 

Project Management Guidance

  • Manage projects and programmes (including grant-funded projects)

  • Prepare Gantt charts, support client delivery to the expected quality, time and budget

  • Organise and manage/moderate client meetings/retreats/workshops/offsite days (with agendas, minutes, and actions)

  • Help clients to choose a suitable CRO/CMO and manage relationship

 
 

Due Diligence

  • Due diligence conduct and support

  • Onsite or remotely

  • Providing teams of adequate breadth of experience to meet client needs

  • Ongoing monitoring of investments

 

Our expertise is broad yet specialised

And we refine every package to target your exact needs