mausmicoroskop
Rethink
animal testing
Provivo Biosciences offers animal testing and other laboratory services. Animal testing is highly controversial. Hardly any other industry moves in a comparable field of tension between ethical and moral issues and the weighing of interests. It is about life, in the truest sense of the word.

This requires a high degree of responsibility - and we accept it. Our message is clear: we have learned from social discourse and want to set new standards for the industry. And: We want to make this process as transparent and open as possible right from the start.

This website is the first step towards this goal.

Less, better and
more ethical animal testing
Animals are our fellow creatures. Like every empathic person, handling animals affects us in a special way. As paradoxical as it may sound, we too would like to do without animal testing entirely. Provivo Biosciences has therefore set itself an ambitious goal: By 2050, we want to ensure that testing on living animals using "in vivo" methods is replaced 100 percent by alternative methods. This includes, for example, an expansion of "in vitro" technology. This means using methods in which testing is performed in a controlled artificial environment outside of a living organism, for example, in a test tube, a Petri dish, or through simulations in IT systems.

However, honesty requires us to be realistic. The functions and interactions in the human organism are too complex to reproduce them realistically in artificial cell cultures or in an IT model using the current scientific and information technology. The complexity even increases with the current knowledge of scientific research. To put it in a deliberately simplistic way: "The liver reproduced in the cell culture does not get a cough."

As a short-term goal, we therefore want to ensure that we continue to conduct only essential animal testing and that such testing is performed as responsibly as possible with regard to animal welfare. To this end, we want to develop new guidelines for our actions together with scientists and representatives of society.

typo
the power of nowProvivo
On the way
to a new ethics and science
We cannot answer these questions and achieve these goals on our own. This involves existential issues that concern us as a society as a whole and that can only be clarified in social discourse. We want to make our contribution to this public discourse:

We invite philosophers, social scientists, biologists, but also lawyers, medical professionals and animal rights  activists as external authors to work with us to further develop ethical and scientific guidelines. This process shall be documented transparently here, where it can be viewed, commented on and criticised by everyone.

the power of nowProvivo
Our ethical guidelines
The Latin prefix “pro” has several meanings. Among others, “pro” corresponds to “for” as well as “in place of”. These two meanings are the cornerstones of an ethical discussion about animal testing: Which guidelines must apply to the conduct of animal testing and which guidelines should be considered to avoid animal testing?

To direct the discussion, we have defined five topics and formulated them as guidelines:
care now
What does the term “responsibility for humans and animals” mean? Which values should guide our actions?
animal now
How should we treat animals in a manner in line with our values? How do these values effect, for example, the origin and handling of laboratory animals?
life now
How do we deal with conflicting goals that arise when the exclusion of animal testing comes into conflict with the responsibility for human life?
trust now
How is trust engendered and maintained? At which levels does trust have to be engendered and what consequences does this have for the establishment and scrutiny of legal requirements for animal testing?
vision now
What should and how could a future without animal testing look like? What motivation do society, business and politics need to provide now?

the power of scienceBiosciences
Our scientific guidelines
Science is based on defined methods and standards. However, this does not mean that these methods and standards are fixed and unchangeable. With new knowledge, it may be necessary to readjust the guidelines for scientific work. This will primarily be the case where - as with animal experiments - ethical issues are also involved.

To guide the discussion, we have defined five subject areas:
the science of technology
What are the requirements for the collection, processing, forwarding, and documentation of scientific data? How can technology be implemented to avoid unnecessary suffering, especially when collecting data?
the science of data
What are the requirements for scientists who must navigate daily between the possibly conflicting priorities of ethical responsibility and scientific tasks? Which concrete measures are helpful in meeting and exceeding these requirements?
the science of excellence
How can national and international legal requirements and guidelines (Animal Welfare Act, GLP, GMP) be optimized so that animal testing is performed as ideally as possible?
the science of guidelines
How can national and international legal requirements and guidelines (Animal Welfare Act, GLP, GMP) be optimized so that animal testing is performed as ideally as possible?
the science of process
How can the entire process - from the first idea to the completion of the animal test - be optimized so that animal welfare remains the focus at all levels?



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the power of nowthe power of science
Acting responsibly today
Responsibility cannot be postponed. The development of ethical and scientific guidelines is a process, the results of which we cannot wait for. We must already face our special responsibility in our day-to-day work.

We are doing this with affirmative measures, which we have already started to implement:
Testing with responsibility
We are already using in vitro methods wherever possible. We are currently at 10 percent, with more tests coming. Wherever we must resort to in vivo testing, we strive to design only low-stress testing. High-stress testing must already pass the most stringent governmental approval hurdles before the tests may be performed in Europe. Companies which approach us with their - sometimes unrealistic - requests receive detailed advice from us. We can fall back on many years of experience and know-how.
Responsible animal use
The laboratory animals we use, such as rabbits, guinea pigs, minipigs, pigs, quails, rats, hamsters and mice, are sourced from licensed, professional laboratory animal breeders.
Responsible animal husbandry
Our animals lead a life in pens or cages as in private households, but under constant medical supervision. Animals that have reached old age with us live in our “senior citizens' residence”. Currently these are around 20 percent of large animals and around 10 percent of small animals.
Personnel with responsibility
With regard to the qualifications of employees in animal testing laboratories, criticism has been
expressed in the past. Provivo Biosciences trains the scientific and animal care personnel annually beyond the government requirements and only employs specialized personnel.
the power of now the power of science
Our
services
 
Histopathology
Approximately 300 chemicals/­drugs have so far been evaluated for carcinogenic properties. The evaluation is carried out by highly experienced veterinary expert pathologists.
Services contrated include preparation of histopathological slides.
Contract Archiving
Archiving of study material generated from studies conducted at Provivo Biosciences is free of charge.
Certificates
GLP
GMP
Reporting
SEND (LIMS-system: PROVANTIS)
CTD-tables
in vitro
All studies are performed in compliance with GLP and are available in conduct with different regulatory requirements: EC/ICH/OECD/FDA/ISO/DIN. Upon request, we can adapt customer’s needs or establish individual methods.
Genotoxicity Studies
AMES test - Bacterial reverse mutation (Full classification or as screening assay: AMES MPF available)
OECD 471
Chromosome aberration test using human lymphocytes or cell lines
OECD 473
Micronucleus test using human lymphocytes or cell lines
OECD 487
Mammalian cell gene mutation test using L5178Y cells (Mouse lymphoma assay)
OECD 490
Mammalian Cell Gene Mutation Tests using the Hprt and Xprt genes (HPRT test using V79 cells)
OECD 476
Comet assay (ex vivo or using cell lines)
OECD 489
Skin and Eye Irritation & Corrosion Studies
Reconstructed human epidermis (EpiDermTM) test method for skin irritation
OECD 439
Reconstructed human epidermis (EpiDermTM) test method for skin corrosion
OECD 431
Membrane Barrier Test Method for Skin Corrosion (Corrositex®)
OECD 435
Reconstructed human Cornea-like Epithelium (EpiOcularTM) test method for eye irritation or serious eye damage
OECD 492
Bovine Corneal Opacity and Permeability (BCOP) test method for eye irritation or serious eye damage
OECD 437
Skin Sensitization
In Chemico Skin Sensitisation - Direct Peptide Reactivity Assay (DPRA)
OECD 442C
ARE-Nrf2 Luciferase Test Method (KeratinoSensTM)
OECD 442D
Human Cell Line Activation Test (h-CLAT)
OECD 442E
Phototoxicity
In vitro 3T3 NRU phototoxicity assay
OECD 432
Potency Assays
G-CSF-proliferation assay
Histamine assay
in vivo
All studies can be carried out according to EC/ICH GLP.
Potency and Batch Control Assays
e.g. hormones
Rats
HMG (Human menopausal gonadotropine; Menotropin)
or individually:
  • FSH (follicle-stimulating hormone) or r-FSH
  • LH (luteinizing hormone)
HCG (Human chorionic gonadotropin)
Estrogen
Residual LH
Mice
EPO (Erythropoietin) (mice)
Botulinum Toxin
Biocompatibility - Testing of Medical Devices (ISO 10993-1)
Evaluation of cytotoxic properties
USP ISO 10993-5
Evaluation of skin irritation
ISO 10993-23
Evaluation of interaction with blood
ISO 10993-4
Evaluation of genotoxicity
ISO 10993-3
Toxicology
All studies can be carried out according to EC/ICH GLP.
Toxicokinetic and pharmacokinetic studies in rodents and non-rodents
Subchronic and Chronic Toxicity in Rodents
For example:
  • Mice (e.g. CD-1®, C57BL/6J)
  • Rats (e.g. Wistar (Han), CD®-rat)
  • Other species possible. Please do not hesitate to contact us.
Dose-range finding studies
For example:
  • p.o., s.c., i.v. bolus or infusion, i.p., (trans)dermal and other administration routes
  • Duration: e.g. single dose, 7, 14, 28 days or escalating dosing schemes
  • Daily, twice daily or weekly administrations
  • Laboratory examinations (e.g. clinical chemistry, coagulation, haematology)
  • Toxicokinetic blood samplings
  • Toxicokinetic evaluation using WinNonlin
  • Dissection with macroscopic examination
  • Study plan, report, archiving for 15 years
All study designs can be adapted to your individual needs. Please do not hesitate to contact us.
Repeated dose studies
For example:
  • p.o., s.c., i.v. bolus or infusion, i.p. and other administration routes such as dietary intake, dermal, intranasal
  • Daily, twice daily or weekly administrations
  • Duration: e.g. 4, 13, 26 weeks
  • With or without recovery period
  • Laboratory examinations (e.g. clinical chemistry, coagulation, haematology)
  • Urinalysis
  • Local tolerance (according to DRAIZE), if required
  • Ophthalmological and auditory examinations
  • Toxicokinetic blood samplings
  • Toxicokinetic evaluation using WinNonlin
  • Immunotoxicity
  • Dissection with macroscopic examination
  • Full histopathology of (mostly) control and high dose animals
  • Study plan, report, archiving for 15 years
All study designs can be adapted to your individual needs. Please do not hesitate to contact us.
Subchronic and Chronic Toxicity in Non-Rodents
For example:
  • Rabbits (e.g. New Zealand White)
  • Minipigs (e.g. Göttingen, Aachen)
  • Other species possible. Please do not hesitate to contact us.
Dose-range finding studies
For example:
  • p.o., s.c., i.v. bolus or infusion, i.p., (trans)dermal and other administration routes
  • Duration: e.g. single dose, 7, 14, 28 days or escalating dosing schemes
  • Daily, twice daily or weekly administrations
  • Laboratory examinations (e.g. clinical chemistry, coagulation, haematology)
  • Local tolerance (according to DRAIZE), if required
  • Electrocardiography and blood pressure
  • Toxicokinetic blood samplings
  • Toxicokinetic evaluation using WinNonlin
  • Dissection with macroscopic examination
  • Study plan, report, archiving for 15 years
All study designs can be adapted to your individual needs. Please do not hesitate to contact us.
Repeated dose studies
For example:
  • p.o., s.c., i.v. bolus or infusion, i.p., (trans)dermal and other administration routes such as intranasal, conjunctival, rectal, intravaginal
  • Daily, twice daily or weekly administrations
  • Duration: e.g. 4 weeks, 3, 6, or 9 months
  • With or without recovery period
  • Laboratory examinations (e.g. clinical chemistry, coagulation, haematology)
  • Local tolerance (according to DRAIZE), if required
  • Electrocardiography and blood pressure
  • Ophthalmological and auditory examinations
  • Toxicokinetic blood samplings
  • Toxicokinetic evaluation using WinNonlin
  • Immunotoxicity
  • Dissection with macroscopic examination
  • Full histopathology
  • Study plan, report, archiving for 15 years
All study designs can be adapted to your individual needs. Please do not hesitate to contact us.
Cancerogenicity
(Mice and rats)
Cancerogenicity: Dose-range finding study
  • Duration: 13 weeks
  • All administration routes
  • Laboratory examinations (e.g. clinical chemistry, coagulation, haematology)
  • Ophthalmoscopy
  • Toxicokinetic blood samplings
  • Gross necropsy, organ weights, tissue preservation
  • Study plan, report, archiving for 15 years
Cancerogenicity: Main study
  • Duration: 104 weeks
  • All administration routes
  • Toxicokinetic blood samplings in satellite animals
  • Gross necropsy, tissue preservation
  • Full histopathology and peer review
  • Study plan, report, archiving for 15 years
Reproduction Studies
according to ICH or OECD
  • Segment I
    Fertility and general reproductive performance
  • Segment II
    Embryotoxicity
  • Segment III
    Peri- and postnatal toxicity
  • Multigeneration studies
    such as OECD 443
Safety Pharmacology
Monitoring of cardiovascular parameters and locomotion by telemetry in Minipigs (n = 4) Latin square design; 4 administrations/animal
Respiratory safety evaluation in rodents (rats or mice)
Irwin test in rodents (rats or mice)
hERG assay (contracted to a trusted European partner)
Analytics
Formulation analytics
(including validation)
HPLC-UV, UV-Spectrometry, GC-FID and ELISA analysis
Other analytical methods contracted to long-term partners in Germany and Europe
Bioanalytics
(including validation)
ELISA analysis at LPT
LC/MS-MS or other analytical methods contracted to long-term partners in Germany and Europe
Immunotoxicology
(Analysis of liquid and tissue samples)
  • MSD
  • Bead Array
  • ELISA
  • ELISpot
Established panels and development of custom panels at request
Inhouse protein conjugations
Cytokines/Hormones
Complement factors
(Bb, C3, C3a, CH50, sc5b, C4d, CRP…)
Immunoglobulins
ADA/neutralizing ADA
(including immunization studies, if required)
TDAR
A plethora of non-immune factors







Contact
LPT Laboratory of Pharmacology
and Toxicology GmbH & Co. KG


Redderweg 8
21147 Hamburg

Phone: +49 40 70 20 20
Fax: +49 40 70 20 22 60

E-Mail: lpt@lpt-hamburg.de