Liof Pharma is a leading CDMO partner, specialized in providing contract development and small/medium scale or personalized aseptic processing and lyophilization manufacturing services, for clinical batches and commercial supply of high value sterile drugs. We are specialized on aseptic filling, especially in biologics, cell therapies and complex formulations.

Our key points:

• • Reliable and high-quality full-service development and
    manufacturing capabilities ensuring on-time product supply.
  • Flexible and disposable equipment, minimizing risks and costs.
  • Premium Customer Service: Flexibility, change management, high
    quality multilingual documentation.
  • Capacity available to react quickly.
  • Focus on process efficiency and continuous improvements to
    maximize production yield and reduced COGS.

Combining a purpose-built facility and experienced development scientists

• • Pilot scale facility with relevant technology, equivalent to those used in GMP Stages.
  • Challenge of complex aspects of the formulation, such as temperature, viscosity, contact with
    materials that could induce aggregation or other changes in the molecule.
  • Simulation of formulation, filling, lyophilization and closing procedures.
  • Design space calculation based on DoE and other Six Sigma tools.
  • Engineering, stability, and validation batches and previous physico-chemical characterization.
  • All in-house validation support.

Flexibility and efficiency combined with regulatory compliance

• • Capacity to deal with limited amount and high value API with special requirements and strict
    timelines. We offer process improvement, scalability and flexibility to meet customers’
    expectations.
  • Purposed built facilities for clinical manufacturing challenges at Liof Pharma: timelines, efficiency,
    versatility and scalability, regulatory acceptance (GMP) and costs.
  • Special equipment for easy format changing, featuring CIP and SIP processes, designed for highly
    efficient small-medium batch production.
  • Manual processing validated for small batches of glass vials, syringes, plastic ampoules and other
    eye drop containers.
  • Maximum Flexibility (single use materials, cold compounding, absence of oxygen, light
    protection, etc.)
  • Preclinical and clinical batch production (Phase I, Phase II, Phase III) with manual, semi-automated
    and automated filling validated processes, matching all customer needs.
  • In house release of clinical batches (QP) and experience to provide regulatory support for the CMC sections of pre-clinical and clinical applications.

Purposed built facilities for personalized manufacturing challenges at Liof Pharma

• • Maximum flexibility through validated manual processing
  • Compatibility with several processes and product types
  • Semi-automation for some processes
  • Highly skilled personnel for achieving full GMP results.

Joining the expertise of high skilled people with latest equipment’s and techniques on development of lyophilization processes and products

• • Expertise in Biologics and complex drugs.
  • Services for developing and optimization of lyophilization cycles.
  • Differential scanning calorimetry (DSC).
  • Freeze-drying microscopy.
  • Determination of the critical temperatures: Tc, Te, Tg’.
  • R&D and pilot scale manufacture: using a 0.45 m2 lyophilizer (GMP compliant if required).
  • Lyophilization cycle characterization and scale-up by means of QbD approach, PAT technologies.
  • Manometric temperature measurement, wireless probes, capacitance manometer.

Cold chain distribution management to complete a full-service package

• • One-stop Shop Supplier for fill & finish.
  • Storage and distribution services to the designated depots, clinical sites.
  • Cold chain expertise is also provided, offering a wide range of validated solutions.
  • These services are designed for one goal: to be your one-stop shop for everything related to development and aseptic fill/finish.