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
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
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