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The Biosimilars Group - Manufacturing
The Biosimilars Group - Non-Clinical Development
The Biosimilars Group - Clinical Development
The Biosimilars Group - Regulatory
The Biosimilars Group - Pharmacovigilance
the biosimilars group workshop projectplan

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:

biosimilardevelopment

biosimilar development

Quality driven biosimilar development

  • Cutting-edge technologies and equipment
  • 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
  • Proprietary CHOvolution™ cell line system for development of high titer cell lines (up to 8 g/L for mAbs).
manufacturing

MANUFACTURING

Robust, cost efficient and flexible
process development and production

  • Perfusion & fed-batch process development
  • USP and DSP development with parallel, controlling biosimilarity analytics targeting high titer USP and high yield DSP
  • Current up-scaling to 2,000 L scale in fed-batch and 1000 L scale in perfusion
  • Commercial manufacturing 4 x 2,000 L fed-batch and 1000 L perfusion by 2020
  • Down-scale model for virus inactivation / removal studies
  • Stability & release testing of Drug Product/Drug Substance (ICH)
nonclinical

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

CLINICAL DEVELOPMENT

Broad regional and therapeutic coverage

PHASE 1 UNITS AND CLINICAL OPERATIONS IN

  • Germany
  • Bulgaria
  • Poland
  • Romania
  • Turkey
  • Serbia
  • Russia
  • India

EMA- and FDA-inspected

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

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

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
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POWER BY MULTIPLICITY

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