Services path · Development under contract

Our technology becomes your capability.

Engage us for a single stage or the whole path from concept to a market-ready product. The intellectual property in what we build for you is yours throughout.

Book a scoping call See the case study

Design → Develop & validate → Comply → Transfer

Hyderabad, Telangana, India

Services is what we build for you · Research is what we are building for ourselves

Every service on this page is work Amplera performs under contract, for a client, with the resulting intellectual property owned by that client. Nothing on this page is a description of Amplera’s internal pipeline — for that, see Research and Innovation.

Phase 1 · Design

Design.

Phase 1

Assay Development

Start with a design built for the setting your test will actually be used in. We select targets, chemistries and formats around your sample, your operators and your conditions — not around whatever is convenient at the bench.

You receiveTarget product profile, in-silico design report, primer, probe and guide sequences, controls strategy, draft SOP.

Technologies applied: PCR and multiplex · CRISPR detection · isothermal amplification · sample preparation

Phase 2 · Develop and validate

Develop and validate.

Phase 2

Optimization

A working assay and a manufacturable one are not the same. We refine sensitivity, specificity and stability until performance holds across operators, instruments, lots and conditions — using designed experiments rather than sequential single-variable runs.

You receive: Optimization dataset, locked reaction conditions, run records, master-mix bridging data.

Phase 2

Analytical Validation

Establish what your test can do, and prove it. Limit of detection, precision, analytical specificity, cross-reactivity and interference, characterized against acceptance criteria agreed before the study starts.

You receive: Validation protocol, validation report, raw data, acceptance-criteria trace.

Phase 2

Clinical Evaluation

Support your clinical claim with evidence, not expectation. Evaluation against reference methods on real samples, reported as agreement statistics with confidence intervals and stated sample numbers.

You receive: Clinical evaluation protocol and report, comparator analysis, agreement statistics.

Phase 3 · Comply

Comply.

Phase 3

Regulatory and Quality

Reach submission without rebuilding your evidence. We structure your technical documentation as development proceeds and work within ISO 13485-aligned quality systems. We prepare technical files for your target market, including CDSCO submissions in India, where we have direct experience.

You receiveStructured technical file sections, risk management file, quality documentation set.

Phase 3

IP and Freedom-to-Operate

Know what you own and what you are free to practice. Patent landscaping, freedom-to-operate analysis and drafting support, delivered with registered patent counsel.

You receiveLandscape report, freedom-to-operate opinion issued by qualified counsel, drafting support.

Phase 4 · Transfer

Transfer.

Phase 4

QC and Lot Release

Ship lot after lot with the same performance. Reference panels, stability studies and release criteria that hold from your first lot to your ten-thousandth.

You receive: Reference panel, stability data, lot release specification.

Phase 4

Technology Transfer

Move your assay to manufacturing without losing performance. Transfer to your site or your manufacturing partner, with scale-up support and bridging data proving equivalence.

You receive: Final SOPs, bridging study report, training, release criteria.

How we work

Five stages. Acceptance criteria defined before each one starts.

Requirements

Design & Feasibility

Development & Optimization

Validation

Transfer & Delivery

Regulatory and Quality run alongside, from stage 02 through delivery

Engagement models

Start where it makes sense for you.

Start here

Pilot

A 2 to 4 week feasibility sprint with a clear go / no-go output, before either side commits further.

Focused

Single stage

One defined stage — optimization, validation or transfer — scoped to a fixed deliverable set.

Full path

End to end

Concept to market-ready product under one accountable scientific lead.

Ongoing

Retained capacity

Named scientific capacity available to your roadmap on a continuing basis.

Who we serve

Molecular diagnostics serve many stages of one value chain. We develop for the stage you are at.

Who we serve

Diagnostics and reagent startups

Reach a validated product without building a full laboratory.

You have a target, a hypothesis and a finite runway. What you do not have is a validation team, a quality system, or two years to build both. Most early diagnostics companies discover this at the worst moment — after the assay works at the bench and before anyone has characterized its limit of detection.

We become your development function. You keep the science, the strategy and the intellectual property. We take the development risk and the documentation burden.

How we help: Assay development · analytical validation · regulatory and quality · technology transfer

You receive: A validated assay, a documentation set a reviewer can follow, and a transfer package your manufacturer can run.

Who we serve

Established diagnostics manufacturers

Additional scientific capacity that moves at the speed of your roadmap.

Your pipeline is longer than your bench. New assays wait behind current ones, and a regulatory submission competes with a product launch for the same team.

We take defined work off your critical path — overflow development, new-assay pipelines, revalidation after a component change, and dossier support — under your quality expectations and your documentation standards.

How we help: Assay development · optimization · analytical validation · regulatory and quality · QC and lot release

You receive: Work delivered to your document standards, with data you can incorporate directly into your own files.

Who we serve

Companies entering India and new markets

Local validation, technology transfer and a regulatory entry partner.

Entering a new market means proving your assay performs on local samples, against local reference methods, under a regulatory framework your team has not worked in before.

We provide local performance evaluation, technology transfer to a local manufacturing partner, and regulatory support for market entry. In India we prepare technical documentation for CDSCO submission and coordinate performance evaluation where a program requires it.

How we help: Local performance evaluation · technology transfer · regulatory and quality

You receive: Local performance data, a transferred and bridged method, and a market-ready technical file.

Who we serve

Pharma and biotech

The test that supports the therapeutic, on the therapeutic’s timeline.

A companion diagnostic that arrives after the drug is a commercial problem. Biomarker assays need analytical validation aligned to a defined plan, and the regulatory path for the test rarely matches the one your team knows.

We develop and validate biomarker and companion diagnostic assays alongside your therapeutic program, with documentation structured for the markets you are filing in.

How we help: Assay development · analytical validation · clinical evaluation · regulatory and quality

You receive: A validated assay with a documentation set built for co-submission.

Who we serve

Academic and clinician innovators

Discoveries deserve to leave the laboratory.

A method that works in your hands, on your samples, with your controls, is a real result — and it is not yet a product. The distance between the two is manufacturability, reproducibility across operators, and evidence structured the way a regulator reads it.

We translate a research assay into a manufacturable, compliant product, and we do it without taking your science from you.

How we help: Assay development · optimization · analytical validation · IP and freedom-to-operate

You receive: A transferable assay, performance data, and clarity on what you own.

Who we serve

Government and public health

Molecular assays that are affordable per result, at national scale.

Programs at national scale need tests that are affordable per result, robust in low-resource settings, and supported by evidence that will survive procurement scrutiny.

We develop assays for tuberculosis, hepatitis, antimicrobial resistance and other priority programs, designed for scale and for the conditions in which they will actually be run.

How we help: Assay development · analytical validation · technology transfer · manufacturing readiness

You receive: An assay designed to a target cost, with validation evidence and a transfer route to a manufacturing partner.

Sectors we develop for

One Health, in practice.

Sector

Aquaculture and veterinary health

Multiplex panels for pathogens that present with overlapping signs, optimized for tissue and water matrices rather than idealized laboratory samples. This is where our validated 4-plex panel was delivered.

Sector

Food and water safety

Detection assays for pathogens and indicators in food and water matrices, designed for testing sites rather than reference laboratories.

Sector

Antimicrobial resistance and tuberculosis

Resistance-gene detection and priority-pathogen panels, including the platform we are developing on our own account.

Case study · A validated 4-plex aquaculture pathogen panel

Four pathogens. One reaction. One run.

Real-time PCR, probe-based · 4 pathogen targets plus internal amplification control · one sample, one run · LOD <10 copies per reaction · analytically validated · SOPs and QC criteria delivered · client owns the IP

Targets

0+IAC

Four pathogen targets plus internal amplification control.

Workflow

0run

One sample, one run.

Sensitivity

<0cp

Per reaction, confirmed in the 4-plex.

Client

Kit, documentation and IP remained with the client.

The challenge

A shrimp-health company needed to detect several economically important pathogens that present with overlapping clinical signs. Running a separate test per target was slow and expensive, and delayed decisions are measured in stock losses.

Our approach

We designed a probe-based four-target multiplex real-time PCR assay with an internal amplification control, balancing primer and probe chemistry so that sensitivity held across all four channels. Extraction was optimized for tissue and water matrices, and the assay was carried through full analytical validation.

Results

Limit of detection — below 10 copies per reaction, characterized per target and confirmed to hold in the 4-plex reaction rather than only in singleplex.

Analytical specificity — no cross-reactivity observed with the non-target organisms tested.

Controls — every reaction carries an internal amplification control, so an inhibited sample is reported as invalid rather than as negative.

Reproducibility — performance confirmed across operators and runs against acceptance criteria agreed before the study began.

What was delivered

A validated 4-plex kit, extraction protocol, SOPs, QC release criteria, and the full validation report. The kit, its documentation and the intellectual property remained entirely with the client.

What it demonstrates. Multiplex assay design, real-time PCR development, extraction optimization and analytical validation — delivered end to end on a real product.

How we handle your data and samples

Confidence, in writing.

Policy

Confidentiality

Every enquiry is handled in confidence. We sign your NDA before technical discussion, or provide ours.

Policy

Intellectual property

Foreground IP — assay designs, sequences, data and documentation created for your program — is yours. Background IP, including OdigOS and our platform methods, remains ours and is licensed for use in your program.

Policy

Sample handling

Samples are logged on receipt, stored under documented conditions, and returned or destroyed to your instruction at the end of the program.

Policy

Data integrity

Records are contemporaneous, attributable and retained for the life of your technical file, and are available to you on request.

Get started

Tell us the target. We will tell you if it can be done.

Send us the target and the sample type. We will come back within one business day with a feasibility view, a likely development path and an indicative timeline.

Every enquiry is handled in confidence. We will sign your NDA before any technical discussion, or send you ours.

Book a 30-minute scoping call Email the team