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OUR NEW UNIQUE OFFER:
THE TBG ONE-DAY WORKSHOP

Get a tailor-made project plan
for your biosimilar of your choice!

UNIQUE EXPERT SUPPORT

All members of The Biosimilars Group are renowned service providers dedicated to the global development of biosimilars specialized in key areas:

biosimilar development

Analytics driven biosimilar development

  • Reference Product (RP) sourcing
  • RP characterization and ongoing RP quality monitoring
  • Full set of analytical methods applied
  • Generation of Quality Target Product Profile (QTPP)
  • QTPP driven Cell Line Development to achieve biosimilarity including clone pool-, clone- and media screening
  • Serum-free media with Cell Line System at high titer (more than 5 g/L biosimilar mAB)
  • Master / Working Cell Bank generation (ICH)

MANUFACTURING

Robust, cost efficient and flexible
process development and production

  • USP and DSP development with parallel, controlling biosimilarity analytics targeting high titer USP and high yield DSP
  • Up-Scaling to 1000 L scale production
  • Down-scale model for virus inactivation / removal studies
  • GMP production for (non-)clinical and market supply
  • Stability testing of Drug Product/Drug Substance (ICH)
  • Release testing of Drug Product/Drug Substance (ICH)

NON-CLINICAL DEVELOPMENT

Demonstrating biosimilarity by targeted intelligent testing

  • General & comparative toxicity
  • Immunogenicity & immunotoxicity
  • Biodistribution
  • Tissue cross reactivity
  • Local tolerance
  • Bioanalytics
  • Comparative PK/PD
  • Similarity for bioactivity

CLINICAL DEVELOPMENT

Broad regional and therapeutic coverage

PHASE 1 UNITS AND CLINICAL OPERATIONS IN

  • Germany
  • Bulgaria
  • Poland
  • Romania
  • Turkey
  • Serbia
  • Russia
  • India
MAJOR THERAPEUTIC AREAS

  • Oncology
  • Renal diseases
  • Central Nervous System disorders
  • Dermatology
  • Ophthalmology
  • Diabetes
  • Metabolic disease
  • Cardiovascular diseases
  • Women´s health
  • Respiratory disease
KEY SERVICES

  • Clinical strategy and scientific advice
  • Medical writing
  • Regulatory submissions
  • Project and site management
  • Monitoring
  • IMP handling and distribution
  • Trial insurance service
  • Sample handling and logistics
  • Data management and statistics
  • Legal represenative service

Your contact for Clinical Development:
Dr. Petra Kowalski
Email: Clinical@TheBiosimilarsGroup.com

REGULATORY

A finger on the pulse of regulatory changes

  • Global regulatory development strategies for biosimilars
  • Due Diligences
  • Scientific Advice procedures (national authorities, EMA, FDA)
  • Pharmaceutical writing (Drug Substance, Drug Product)
  • Medical writing
  • Labeling (e.g. SmPC/Patient Information; US SPL labeling format)
  • Dossier compilation (e.g. eCTD, SDTM/ADaM and SEND format)
  • MA procedure management

PHARMACOVIGILANCE

Protect your success

  • Case management
  • Signal and risk management
  • PV writing (e.g. DSURs, Risk Management Plans)
  • Creation, adaptation and maintenance of local and global PV systems
  • Creation of PV compliance systems
  • Preparation and conduct of PV audits as well as inspection preparation
  • Creation and update of PV agreements

POWER BY MULTIPLICITY

The Biosimilars Group is covering all aspects of biosimilars development from candidate identification to marketed product.