Cell Line Development

We offer you comprehensive expertise in the development of high performance cell lines. Do you have a sequence or a vector? We develop and establish a stable cell line and cell Banks (MCB and WCB) for your molecule.

Our Expertise

  • Application of mammalian cell lines for the expression of recombinant proteins
  • Development of high-yield production cell lines
  • Animal component free media
  • Our proprietary technology platform TurboCell™

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Your Benefits

  • Predictable, robust, and scalable CHO cell lines
  • Compliance to cGMP guidelines
  • Royalty and license free
  • For all type of recombinant proteins

Process Development

We are specialists in development, optimization and validation of cell culture and the purification of recombinant proteins. We work with time and cost-saving generic technology platforms. We develop the customized process for your active ingredient and provide an efficient process transfer.

Our Expertise

  • Development of upstream processes (USP) and downstream processes (DSP)
  • Platform as well as customized processes
  • Process characterization and validation
  • Cell culture in fed-batch, continuous & perfusion mode
  • Enrichment of your protein and removal of all impurities

Your Benefits

  • Long-term experience in process development
  • Reliable and fast process implementation
  • Transfer and optimization of your processes
  • Customized concepts for a broad range of biopharmaceuticals
  • Our know-how with complex and difficult proteins

Formulation Development

Strategic Alliance with Leukocare AG
Advanced formulation development exclusively by Leukocare

Our Expertise

  • In addition to industrial standards advanced formulation development based on the SPS® (Stabilizing and Protecting Solutions) formulation technology platform
  • Improved stability of therapeutic proteins in dry and liquid formulations, including highly concentrated products
  • Meets current and emerging demands in the increasingly competitive and cost-sensitive healthcare market

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Your Benefits

  • Best-in-class formulation provides significant competitive advantages
  • Advanced formulation maximizes product potential
    • Provides optimal direct benefit to patient, physicians, payers
    • Maintains efficacy and safety of products during storage
  • Improved cost efficiency in product planning and development
    • Optimizes planning (especially timing the start) of clinical trial programs
    • Early adoption of an advanced formulation in clinical trials can avoid the need to repeat them and simplify compliance with regulatory agencies
  • Improved market implementation logistics

Analytical Development

With over 40 years of experience in the development of analytical methods and our wide range of methods, we ensure the quality and purity of your product according to all cGMP guidelines.

Our Expertise

  • Development of various testing services including identity, purity and potency testing
  • Broad spectrum of analytical methods
  • cGMP compliant method validation and transfer

Your Benefits

  • Fast and flexible development of robust analytical methods
  • Comprehensive portfolio
  • Long-term experience and reliability
  • Expertise with diverse recombinant proteins including also biosimilars