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Pubrica Bioscience: Laboratory Research, Testing, Formulation and Pilot Manufacturing
Pubrica Bioscience provides laboratory research, analytical testing, formulation development and pilot manufacturing, supported by scientific and technical documentation. We help clients plan studies, generate and interpret data, and prepare documentation for product development, regulatory submissions, claim substantiation and scientific publication. The work runs in our own FSSAI-certified laboratories at TICEL Biotech Park, Chennai, alongside biologics process development to pilot scale. Laboratory and documentation teams coordinate study objectives, methods and reporting requirements from the outset.
Each service line lists the work covered and the deliverables you receive.
- Our own laboratories and scientists
- Pilot manufacturing on site
- Studies planned around the required documentation
- Analysis plan agreed before data collection
- ISO 9001:2015 · cert. H3CR9TCU20251212INDQM10N
Service Scope
Laboratory Testing and Scientific Documentation Services
We provide claim assessment, laboratory testing, study design and written reporting within one team. Clients do not need to coordinate a separate consultant, laboratory, research organisation and writer. Acceptance criteria, the reporting standard and the statistical analysis plan are agreed before testing begins. Open any service below to see what it covers.
01 Claim substantiation and product dossiersAssessment of permitted claims in your target market and preparation of the supporting evidence file.
We assess what may lawfully be claimed in your target market and run a systematic review against the evidence that regulator requires. We then prepare the substantiation file or product dossier, including the work needed to address any evidence gaps. If the evidence does not support the claim, we report this in writing.
02 Analytical and stability testingComposition, actives, contaminants, microbiology and shelf life, in our own laboratories.
Compositional analysis, quantification of the actives a claim depends on, heavy metals and residues, microbiology, and real-time and controlled-temperature shelf-life studies. Each report states the method, instrument and acceptance criterion, and follows the format the receiving regulator or customer expects.
03 Formulation and pilot manufacturingPrototype development, reformulation, scale-up and manufacture of study batches.
Prototype formulations built to a target specification, cost ceiling and intended claim. Reformulation of existing products for an ingredient change, new market requirements or a failed stability result. Scale-up with process parameters recorded during the work. The pilot unit also manufactures matched test and control batches for studies.
04 Biologics process developmentUpstream and downstream process development to pilot scale, with a supporting development report.
Fermentation at five, forty and one hundred litres, with a complete downstream train: cell disruption, high-throughput centrifugation, tangential flow filtration at lab and pilot scale, chromatography and FPLC, and lyophilisation. One hundred litres is pilot scale, not commercial scale, and we state this at the outset.
05 Reporting and publicationDossier sections, regulatory responses and manuscripts, written by the team that holds the data.
Pubrica prepares the documentation in-house. Study reports follow the reporting standard the study design requires, dossier sections follow the structure the receiving regulator expects, and manuscripts follow the reporting guideline the target journal applies.
Our Process
Claim Substantiation Process: Seven Steps
The steps run in order, from claim feasibility to final documentation, and you can join at any step. Many clients start at evidence gap analysis or analytical work. Starting with claim feasibility can change the scope of work required.
Claim feasibilityWhich claims are permitted in the target market, and the evidence that regulator requires.
Evidence gap analysisA systematic review against that requirement, identifying only the studies still needed.
Design and analysis planStudy design and statistical analysis plan agreed and recorded before data collection.
Analytical workComposition, actives, contaminants, microbiology and stability, in our own laboratories.
Pilot batchesPrototypes, scale-up and manufacture of the study material.
Final documentationThe dossier or substantiation pack, structured as the receiving regulator expects.
Scientific publicationA manuscript for journal submission, where the findings merit publication.
Facilities and Team
Laboratories and Scientific Team
All work is carried out in our own laboratories by our own scientists. Details of the facilities and the team are set out below.
Facilities
Our own laboratories
Four FSSAI-certified laboratories and a pilot manufacturing unit at TICEL Biotech Park, Chennai. Products are tested and manufactured in the same building.
- Food research, nutraceutical, cosmetic and pet nutrition laboratories
- A pilot manufacturing unit on the same site, where study material is produced
- Analytical, formulation, stability and pilot manufacturing work
- Project schedules managed by our own team
Team
Scientific team
Our own scientists, led by an R&D head with a doctorate in biotechnology. The scientist who carried out the work answers your questions about it.
- A named scientist assigned to every project
- Analysts who run the assay and write the report
- Instruments with regulated-data implications run with audit trails and controlled software
- Method, instrument and acceptance criterion on the face of every report
Analytical and stability testing
Composition, Contaminant, Microbiology and Shelf-Life Testing
Analytical testing is where most clients start, and it is often repeated as a product develops. Each report states the method, instrument and acceptance criterion, in the format the receiving regulator or customer expects.
Compositional analysis
Proximate composition, moisture, ash, and macronutrient and micronutrient profiling.
Actives and markers
Quantification of the compound a claim depends on, by UPLC and UV–Vis, with the method documented.
Contaminants
Heavy metals, pesticide and solvent residues, adulterants, and the substitution checks botanicals need.
Counts and challenge testing
Total counts, pathogen screening and preservative efficacy.
Stability studies
Real-time and controlled-temperature work, with the protocol written to the standard your market applies.
Molecular confirmation
Species and strain identity by sequencing and real-time PCR, where label identity must be confirmed.
Formulation and pilot manufacturing
Formulation and Pilot Manufacturing Services
We develop formulations and manufacture pilot batches on site, so we can supply a reformulated batch as well as advice on it. The pilot unit also produces study material that matches the product intended for sale.
Prototype development
A formulation built to a target specification, a cost ceiling and a claim you intend to make.
You get a prototype
Reformulation
Reworking an existing product for a changed ingredient, a new market’s rules or a failed stability result.
You get a revised formula
Scale-up
Bench formulation taken to pilot scale, with the process parameters recorded as you go.
You get a documented process
Study material
Test and control batches made to the same specification, for a valid comparison.
You get matched batches
Stability batches
Manufactured and placed on stability study, so shelf-life data reflect the product you sell.
You get a shelf-life dataset
Biologics process development
Biologics Process Development to Pilot Scale
We provide upstream and downstream process development, with fermentation at five, forty and one hundred litres and a complete downstream train. One hundred litres is pilot scale, not commercial scale, and we state this at the outset. The deliverable is a development report structured for the relevant section of the submission.
Upstream
Fermentation and cell culture
Clone and media screening, fed-batch optimisation, and scale-up through the three fermenter sizes, with the process parameters that matter recorded as the work proceeds.
Downstream
Capture, polish and dry
Cell disruption, high-throughput centrifugation, tangential flow filtration at lab and pilot scale, chromatography and FPLC, and lyophilisation, developed for each process.
Characterisation
Analytical
Intact mass and peptide mapping by MALDI TOF/TOF, purity by UPLC and electrophoresis, identity by Western transfer.
Cell banks
Identity and stability
Insert verification by sequencing, copy number and mycoplasma by real-time PCR, viability and phenotype by flow cytometry.
The output
A development report
Structured to the section of the submission it is destined for, written by our regulatory writing team.
Who We Serve
Product Categories and Regulatory Frameworks
Laboratory methods are similar across these categories. The documentation differs, because each is regulated differently. We prepare the file each framework requires.
Nutraceutical and health supplement
FSSAI’s health supplements and nutraceuticals rules in India, EFSA health claims and the novel food route in the EU, and structure/function claims and new dietary ingredient notifications in the United States.
Food and beverage
Compositional compliance, labelling and nutrition claims, shelf-life substantiation, and the evidence behind a functional positioning.
Cosmetic and personal care
India’s Cosmetics Rules, the safety report the EU cosmetic regulation requires, and safety substantiation under the United States cosmetics modernisation act, which makes it a legal requirement.
Pet nutrition
Nutritional adequacy against AAFCO and FEDIAF, with palatability and digestibility studies designed and reported by us.
Pharmaceutical and biotechnology
Process development and characterisation to pilot scale, with the development report written to the submission section it belongs in.
Independence and Study Integrity
Our Independence Commitments
Because we both run studies and prepare claim documentation, clients may ask how the work stays independent. The commitments below are built into how every project is run.
We do not design a study to reach a conclusion
The design and the statistical analysis plan are fixed and recorded before data collection, and the finding is reported whether or not it supports the claim.
We do not sign what we are not qualified to sign
We prepare a cosmetic product safety report in full; the assessor who signs it must hold the qualification the regulation names. Where that person is not on our team, we say so and the pack goes to yours.
We do not issue a result without the method behind it
Every report states the method, the instrument and the acceptance criterion. We do not release a result without them.
We do not claim a certification we do not hold
Every certification listed on this page is currently held and shown with its scope. Copies of the documents are available on request.
We do not run human or animal studies in-house
Human studies require an independent ethics committee and a registered protocol, and pet palatability and digestibility work requires a site equipped for it. What you get from us is the design, the statistical analysis plan and the written result.
Compliance and Standards
Certifications and Reporting Standards
Each certification is listed below with its scope. Copies of any document are available on request.
ISO 9001:2015
Quality management across Pubrica’s research, writing and laboratory operations.
H3CR9TCU20251212INDQM10N
FSSAI licence
Our own food, nutraceutical, cosmetic and pet nutrition laboratory operations and the pilot manufacturing unit alongside them.
On request
Instrument data integrity
Audit trails and controlled software on instruments where regulated data is generated.
Audited on request
Reporting standards
Study reports written to the standard the design requires — CONSORT 2025, PRISMA 2020, STROBE and ARRIVE 2.0 as applicable.
EQUATOR Network
Copies of these documents are available on request. If your file requires a certification we do not hold, we will tell you.
How It Works
Our Process: Five Stages
Most projects begin with a proposed claim and a question about whether it can be supported. Answering that question before a study starts costs less than answering it afterwards.
Stage one
Scoping assessment
What you want to claim, which market, and what that regulator requires behind it. Two business days.No charge
Stage two
Written proposal
The scope of work, the sequence, which work runs in our laboratories and which in our documentation team, and the cost.
Stage three
Protocols agreed
Protocols and the statistical analysis plan agreed and recorded before any work starts.
Stage four
Laboratory work
Results are released as they become available, so any issue can be addressed during the project.
Stage five
Final documentation
The dossier, substantiation pack, development report or manuscript, written by the team that holds the data.
FAQs
Frequently Asked Questions
All certifications are listed above with their scope, and copies are available on request. If your file needs a certification we do not hold, tell us what the file is for and we will confirm this before work begins.
The product or formulation, the claim you want to make, and the target market. That is enough for the scoping assessment. If you have a specification, a previous test report or a competitor’s claim, please send those too; they usually shorten the project.
We design and report the study. Human studies require an independent ethics committee and a registered protocol, and pet palatability and digestibility work requires a suitably equipped site. We provide the study design, the statistical analysis plan and the written report.
Pilot scale. The pilot unit produces prototype and study-material batches, and biologics fermentation runs to one hundred litres. This covers development, stability and study material. We do not provide commercial manufacturing.
Yes. The analysis plan is fixed before data collection, and the finding is reported whether or not it supports the claim. If the evidence does not support the claim, you receive that conclusion in writing.
Each programme is quoted after the scoping assessment, based on how many steps of the process you need. The scoping assessment is free, and you keep the written summary of the required work whether or not you proceed.
Discuss your laboratory or claim substantiation requirements
A scoping assessment is free and takes two business days. You receive a written summary of what your claim requires, which evidence you already have, and what is still needed.