Value-added generic development

Value-added generic development
Product Description

Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
Although in general the overall aim of value-added generic development projects is focused on improving the safety, efficacy and/or the ease of administration, we are also specialized in executing development programs where the primary or sole object is the evasion of existing product patents.

Avivia BV

  • NL
  • 2017
    On CPhI since
  • 1 - 24
    Employees
Academic/Research
Consultancy
Contract Service

Avivia BV

  • NL
  • 2017
    On CPhI since
  • 1 - 24
    Employees
Academic/Research
Consultancy
Contract Service

More Products from Avivia BV

  • Excipia       Experts in excipient analysis, characterization and deformulation / reverse engineering

    Product Excipia Experts in excipient analysis, characterization and deformulation / reverse engineering

    Excipients can have an important impact on the manufacturability and pharmaceutical performance of a formulation. It’s therefore important to identify and control functionality related characteristics (FRCs) of excipient materials in order to achieve safe, robust and stable products. Experience has taught us that the limited information on an excipient Certificate of Analysis is in many cases not useful in explaining observed formulation properties or in finding product specific FRCs. Excipia has therefore spent thousands of hours setting up a unique set of complementary physicochemical methods and ingenious sample preparation techniques covering many different excipients. For some excipients, we have been analyzing up to one hundred unique batches of different suppliers to fill our knowledge database. Our experience in excipient characterization enable us not only to identify and quantify individual excipients in a drug product (deformulation) but also to reveal and compare hidden excipient properties like the presence of potential reactive impurities or functional groups, degradation products and related substances, but also molecular weight distributions, degree of substitution, substituent distribution, monomer ratio and many other featured characteristics. Excipia offers fast and flexible hands-on solutions and troubleshooting services to excipient manufacturers and pharmaceutical drug companies that are encountering challenges such as: • Competitor research and analysis • Selection or change of supplier of excipient or starting material • Batch to batch product performance variation, e.g. manufacturability, stability, release, etc. • Identifying functionality related characteristics and setting product specific (in house) specifications • Implementing a Quality by Design approach • Manufacturing process or site changes • Deformulation/Reverse Engineering Feel free to get in touch with our experts to see how we can help you in making your products safe, robust and stable. Be in control of your product!   https://www.excipia.eu/
  • Pharmaceutical R&D Services

    Product Pharmaceutical R&D Services

    Having decades of hands-on experience on a wide range of (complex) technologies and a many different types of products, our Pharmaceutical experts are able to fully execute and/or support the development of any finished dosage form, formula or process, as well as the transfer and scale-up of a developed product to a manufacturing facility.

    With our pragmatic and creative development mentality, we deliver what a client needs. We perform best by exploring together the motivations behind their request.

    Read more: https://www.avivia.nl/lab-capabilities/pharmaceutical

  • Dissolution Testing  -  R&D services

    Product Dissolution Testing - R&D services

    For us dissolution testing is never a routine test but an essential tool in pharmaceutical formulation development to:

    • evaluate the physicochemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation)
    • compare prototype formulations (preclinical selection),
    • elucidate drug release mechanism (diffusion, erosion, etc.)
    • as an indicator of stability (e.g., temperature, humidity)
    • as an indicator of the robustness of the manufacturing and
    • assure safe release and reproducibility of the products to the market.

    Dissolution testing is to be a discriminatory method that is sensitive to variables that impact the release rate and ideally is predictive of bio-performance.

    Read more: https://www.avivia.nl/lab-capabilities/dissolution

  • Analytical research & development

    Product Analytical research & development

    Our analytical experts know what it takes to bring a pharmaceutical product to the market, from discovery, feasibility to GMP. Having worked with more than 100 unique molecules and even more formulations, we may state that we have faced the most difficult CMC challenges that are involved.

    With our creative research mentality, we deliver what a client needs. We perform best by exploring together the motivations behind their request.

    - characterisation and stability
    - method development & transfer
    - problem solving and troubleshooting
    - excipient knowledge platform

    Our in-house capabilities include techniques such as:

    UHPLC-MS (single quad); UHPLC-UV/DAD; UHPLC-CAD; HPLC-RI; SEC; IC; GC-MS (single quad); GC-FID;
    Dissolution USP I (basket), II (Paddle), III (Biodiss), IV (flow through cell); Pion µDiss Profiler; UV spectroscopy; microscopy;
    forced degradation equipment; light-stress equipment (suntester); climate chambers and more.

    Other technologies and services are accessible within our extensive network, like NMR, SEM, BET, PSD, density, etc.

    Read more: https://www.avivia.nl/lab-capabilities/analytical
  • Excipient Quality Testing and Selection Services

    Product Excipient Quality Testing and Selection Services

    Excipient testing, composition and variabilityExcipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases the exipients are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.

    Besides differences in process technology, conditions and parameters, these raw materials required to produce the excipient are an important source of variability in the composition of excipients.

    Excipient variability and the presence of reactive functional groups or reactive excipient-related substances pose a risk. Excipia offers excipient selection and extra-compendial excipient testing that can reduce this risk or help troubleshoot and optimize drug formulations.

     We can help excipient users to choose the most appropriate excipient manufacturer, select the most suitable excipient quality grade for their finished dosage form, or define custom excipient specifications to control product performance, quality and safety.

    In addition, we can assist manufacturers of excipients in selecting and controlling their raw materials, production processes and optimizing product reliability and consistency.

    Read more: https://www.excipia.eu/quality-of-excipients/

    Contact us: https://www.excipia.eu/contact/

  • Pharmaceutical Deformulation / Reverse Engineering

    Product Pharmaceutical Deformulation / Reverse Engineering

    Our experience in excipient characterization and deformulation of pharmaceutical formulations gives us the opportunity not only to identify and quantify individual excipients in a complex pharmaceutical formulation, but often also confirm the excipient grade, excipient quality and sometimes even the excipient source of the ingredients.

    Customers approach us for our deformulation services for several reasons:
    •  For specific biowaiver bioequivalence (BE) strategies Q1/Q2(Q3) deformulation may be required to produce a generic product that exactly matches a drug on the reference list
    • To investigate a competitive or reference formulation
    • To determine if patents have been infringed
    • To improve an underperforming formulation

    Thanks to the unique combination with a pharmaceutical development and dissolution testing services within Avivia, we can provide comprehensive insight into different product properties, such as detailed release performance, product composition or insight into the applied production techniques or processes.

    If desired, we can reconstruct a copy of the product.

    Read more : https://www.excipia.eu/deformulation/

    Contact us at : https://www.excipia.eu/contact/
  • Excipients Formulation Development Support

    Product Excipients Formulation Development Support


    Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. Though excipients were at one time assumed to be “inactive” ingredients, it is now understood that excipients can have an important impact on the pharmaceutical and chemical performance of a drug product formulation. It’s therefore important to identify unknown and control Functionality Related Characteristics (FRC) of excipient materials, to manage their effects on pharmacodynamics and pharmacokinetics and achieve safe, robust and stable pharmaceutical products.
    Excipia can help companies with their formulation development.

    • to identify critical (combinations of) excipients and Functionality Related Characteristics (FRCs) in formulations,
    • investigate formulation and excipient batch-to-batch variability,
    • troubleshoot underperforming pharmaceutical formulations,
    • select specific excipient batches, grades, or suppliers,
    • set in-house excipient specifications for customized pharmaceutical product properties.

    In addition, due to the unique combination with a pharmaceutical development and dissolution testing services within Avivia, Excipia can provide comprehensive insight into various product features, such as detailed release performance, and apply and test new insights with small-scale development batches.

    Read more: https://www.excipia.eu/formulation-development/

    Contact us: https://www.excipia.eu/contact/


  • Life cycle management of branded products

    Product Life cycle management of branded products

    Our ‘life cycle management’ development services are focused on maximizing the value of your drug during its product life cycle. Typically, we are asked by pharmaceutical and biotech companies to develop new product formulations of branded drugs to anticipate on patent expiries, generic competition and profit erosions. Besides hands-on formulation and CMC development work, we also provide specialized regulatory, intellectual property and competitive intelligence solutions in order to proactively plan your molecule’s path to success from the start.
  • Complex formulation/CMC development of NCEs

    Product Complex formulation/CMC development of NCEs

    Avivia is known amongst the drug development community for being able to deliver successful solutions for complex and challenging formulation and CMC development projects. Typically, pharmaceutical companies and smaller drug development firms approach us with development programs that have derailed or – in the worst case and despite all previous efforts – have reached a dead end. Besides hands-on formulation and CMC development work, we also provide specialized regulatory, intellectual property and competitive intelligence solutions in order to proactively plan your molecule’s path to success from the start.

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