NextPharma PowerPoint Template · Analytical method validation and stability registration...


Transcript of NextPharma PowerPoint Template · Analytical method validation and stability registration...

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    • Companies introduction

    • NextPharma skills and capabilities

    • Explore how we can work together

  • Company introduction

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    NextPharma at a glance

    Leading European pharmaceutical CDMO focused on attractive technology niches

    >€200 million revenues

    5 to 7%LTM annual growth

    Regulated byFDA (USA)

    EMA (Europe)

    Anvisa (Brazil)


    Manufacturing facilities




    4 60+End markets served


    24%In Quality roles

    ProductsSolids / Pellets


    Liquids / semi-solids

    Penicillins / Cephalosporins


  • Our 7 Centres OfExcellence

    Now with over 150 customers across 6


    London, UK• Head Office

    Limay, France• Liquids

    • Suppositories

    Bielefeld, Germany• Modified Release

    • Analytical Services

    Göttingen, Germany• Solids

    • Clinical Trials Services

    Berlin, Germany• Penicillins

    Waltrop, Germany• Hormonal solids & semi-solids

    • Semi-solids

    Göttingen, Germany• Cephalosporins

    Tampere, Finland• Ophthalmics (BFS + 3P)

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    How NextPharma has successfully grown organically

    Positive differentiators of NextPharma in our industry

    Project management & excellent product transfers

    Customer-focused reputation

    Synergies between production & development

    Financial stability

    Flexible partnerfast to act / lean

    Local and globalperspective

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    Continues focus on solid Organic growth

    Commercial and operational successes, and investment in growth

    ✓Continuous strong revenue and EBITDA growth

    ✓ Long term vision though customer contract extensions and new business wins

    ✓High Quality standards: Successful FDA re-inspections

    ✓Best in class operations with key investments in our sites:

    • Successful refurbishment of Berlin (dedicated Penicillins site)

    • Goettingen : major capacity extension for solid dosage forms

    • Tampere : new High speed BFS Unidose line

    • Packaging line at Waltrop and Berlin

    • New liquid filing line at Limay

    • Logistics expansion

  • Skills and Capabilities

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    Equipped and ready to support you along the entire product lifecycle

    Clinicalsupply Commercial



    • Formulation and process development

    • Analytical method development

    • Stability testing

    • Clinical batch manufacture

    • Phase I – IV clinical trials supply

    • Validation batches

    • Technology transfer

    • Launch and supply

    CMC regulatory affairs

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    Pharmaceutical Development ServicesAlways tailored to your precise needs

    ✓ Depth of scientific knowledge applied to

    your project

    ✓ Scientific and regulatory advice

    ✓ Direct, fast communication through

    your dedicated project manager

    ✓ Seamless links to your clinical and

    commercial supply

    ✓ Flexible approach to your evolving needs

    API, comparator, excipient sourcing and testing

    Pre-formulation and formulation development

    Analytical method development

    Microbiological testing

    Manufacture, packaging and distribution of clinical supplies

    Scale-up and process development

    Analytical method validation and stability registration

    Technology transfer to production

    Compilation of CMC modules for CTAs, CTDs, NDAs, INDs dossier submission and variations

    QP release

    In Summary

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    Pharmaceutical Development Services

    With diversified services


    Optimisation of composition and manufacturing process

    Product Development

    Full characterisation / reverse engineering of related products

    (if required)

    Process development and validation

    Quality by design including quality target product profile, gap analysis and

    risk assessment

    Formulation and manufacturing process strategy tailored to individual

    project requirements

    Product Optimisation Scale-up and process delivery

    Supportive stability and stress studies on prototype formulations

    Scientifically guided setup of product specifications

    Analytical method development and method validation

    Manufacturing of registration batches

    ICH stability studies

    Our across-site highly-skilled development team enables us to provide a maximum level of service and competence for every single project.

    Full ICH validation of analytical methods

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    Analytical Services

    ✓ Depth in scientific knowledge

    ✓ Scientific and regulatory advice

    ✓ Consistent high quality to EMA, FDA, ANVISA, ICH

    ✓ Direct, fast communication through a dedicated

    project manager

    ✓ State-of-the-art laboratory and equipment

    ✓ >25 years experience as Analytics provider

    ✓ High flexibility to your evolving needs

    Analytical Chemistry for raw materials, bulk and finished


    QP Release

    Method development, validation and transfer

    Stability storage and testing


    Key Services

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    Clinical Trials Supply services

    From an experienced CTS partner that understands your needs may evolve


    Modu-C station | Göttingen, Germany

    NextPharma CTS

    A truly flexible approach to ensure your project keeps right on track

    Seamless links to development and commercial supply

    Always reliably informed with an experienced and dedicated project manager

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    Clinical Trials Supply ServiceOur Full Services offer

    Clinical ManufacturingPackaging & Labelling

    Storage & Distribution Regulatory Support

    ❖Blinding/Encapsulation capabilities for all major dosage forms

    ❖Primary and secondary packaging of solids, semi-solids, liquids

    ❖ Labelling and secondary packaging of injectables and other dosage forms

    ❖Kit packaging


    ❖Manufacturing capabilities for IMPs and placebos

    ❖ Logistics solutions meeting CGSP/GDP regulations

    ❖ Storage at controlled temps 15-25°c | 2-8°c | -20°c

    ❖ Storage of controlled substances

    ❖Worldwide distribution at controlled temperatures

    ❖Return and reconciliation

    ❖Creation of IMPD/IND

    ❖QP Auditing / QP Release

    ❖ Import and export of IMPs and controlled substances from and into third countries

    ❖Randomisation lists and emergency letters

    ❖Also, comparator sourcing

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    Commercial ManufacturingExperts in solids, semi-solids and liquids

    SolidsPowders for Suspensions

    Pellets TabletsFilm Coated

    TabletsHard Gelatine


    • Dry syrups• Bottles• Sachets

    • Taste masking• Modified release of API• Protection of API

    • Compressed Powder• Compressed Granules • Compressed Pellets • Bi-layer (2 different blends

    compressed in one tablet)• Modified release matrix tablets• Orodispersible• Mini-tablets

    • Coating for taste masking

    • Coating for modified release of API

    • Coating for protection of API

    • Powder blend in capsules• Granules in capsules • Pellets in capsules• Tablets in capsules

    M o d i f i e d R e l e a s e

    Liquids• Buccal sprays• Topical sprays• Nasal sprays• Oral solutions & Suspensions in bottles or ampoules• Eye drops (BFS Single Dose & Multi Dose + 3 P & PFMD bottles)

    Semi Solids• Topical gels & creams• Ointments• Suppositories

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    Regulatory StatusCentres of Excellence Responding to the WorldwideHighest Quality Standards








    Anvisa(Brazil) EMA


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    Why select NextPharma as your partner?



    ✓ Strong, secure


    ✓ Demonstrating innovation

    and world-class technical


    ✓ Modern outlook /


    ✓ Competitive


    ✓ Recognised by customers

    for delivering a fast


    ✓ Ability to react and

    deliver the ‘smart’



    ✓ Proven excellence

    creating client specific


    ✓ Depth of understanding

    and flexible approach

    ✓ Application of

    enthusiastic scientific


    ✓ Proactive communication

    S m a r t e v e r y t i m e