Proantek Research Laboratories

About Proantek

Founded & Managed by Biopharma Industry Professionals

Proantek Research Laboratories Private Limited” is a global biopharma contract research organization (CRO) specializing in process development, structural and physicochemical characterization of biopharmaceuticals, peptides, vaccines, oligonucleotides and Cell & Gene Therapy.

Our capabilities encompass , comprehensive structural, physicochemical and biophysical characterization along with upstream and downstream process development of biopharmaceuticals, including recombinant proteins and monoclonal antibodies, as well as synthetic peptides and oligonucleotides.

Corporate Purpose

Our Mission

"To deliver world-class scientific services with exceptional quality and precision, enabling client success and advancing biopharmaceutical innovation and healthcare."

Scientific Capabilities

Integrated Core Services

Proantek’s scientific team brings decades of biopharmaceutical industry experience, delivering expert guidance and specialized services across analytical development, advanced characterization and process development.

Primary Structure Analysis

N-terminal Sequencing
Amino acid composition
Extinction coefficient determination
Peptide mapping and sequencing
Intact Mass analysis
Sulhydryl groups & disulfide mapping
Conjugate Site analysis

Higher Order Structure Analysis

Circular Dichroism (CD) spectroscopy
Fourier Transform Infrared (FTIR) spectroscopy
1D and 2D NMR
Differential Scanning Calorimetry (DSC)
Fluorescence spectroscopy
Free cysteine analysis (Ellman’s Method)

Product variants and PTMs

Deamidation & Oxidation levels by MS
Glycan analysis & characterization
Misincorporation in Biologics
Glycation
N-terminal pyroglutamate
Cysteinylation
C-terminal heterogeinity
Glycan Occupancy

Functional Characteristics

Surface Plasmon resonance (SPR) based receptor binding assay

Peptides specific characterization

Chiral Purity using GC-MS
Product Specific Variants using LC-HRMS
Peptide Content & Counter Ion

Aggregate Analysis

Analytical Ultracentrifugation (AUC)
SEC-MALS ( Molecular weight determination)
SDS-PAGE
Dynamic Light Scattering (DLS)

Complete method development and qualification for biosimilars, synthetic peptides and oligonucleotides

Analytical Characterization including (Primary, Secondary & Higher Order Structure Analysis)
Glycan analysis and site occupancy for monoclonal antibodies and hormones
Methods for residual process-related impurities including antifoams (e.g. Struktol)
Methods for excipient quantification in biosimilars including sugars and surfactants

Process Development for Biosimilars and Recombinant Biologics

Cell line and clone evaluation
Media screening, feed strategy development and culture optimization
Upstream process development and scale-up in bioreactors
Harvest clarification and primary recovery optimization
Downstream purification development, including chromatography, filtration and Resin reuse study
Scale-down model, Process characterization, scale-up and technology transfer support

Formulation development for biosimilars, synthetic peptides and oligonucleotides

Stability studies as per ICH guidelines
Pre-formulation studies, including solubility, stability and excipient compatibility
Formulation screening and optimization for biologics and synthetic peptides
Stress, stability and degradation-pathway assessment
Drug-product process development, including freeze–thaw, agitation and container-closure compatibility studies

CMC development strategy and regulatory roadmap for biologics, biosimilars and synthetic peptides

Preparation and review of quality documentation for IND/CTA, BLA/MAA and CTD Module 3 submissions
Regulatory-compliant analytical method development, validation, specifications and stability programs
Comparability, biosimilarity and regulatory gap assessments, including responses to agency queries

Value Proposition

The Proantek Advantage

Merging scientific rigor with compliant electronic workflows to de-risk biopharmaceutical development pipelines.

01 / PRODUCT LIFECYCLE MANAGEMENT

Expert Guidance

Our experienced scientists bring expertise across the complete product lifecycle. We work closely with clients to design tailored process development, analytical and characterization programs aligned with each product’s development stage and regulatory requirements.

Scientists working in the Proantek laboratory

02 / INTEGRITY ARCHITECTURE

Quality & Compliance

We follow ALCOA+ data-integrity principles to generate reliable, traceable and regulatory-ready data. Our integrated eLNB, LIMS and 21 CFR Part 11-compliant electronic-signature systems support a secure, connected and paperless laboratory environment.

03 / ECONOMIC RIGOR

Cost-Efficient Solutions

Our efficient operating model enables us to deliver high-quality scientific services at a competitive cost, providing greater value without compromising scientific rigour, quality or compliance.

Research team reviewing development data

Facilities & Equipment

State-of-the-Art Infrastructure

Proantek laboratory facility in Navi Mumbai

Maharashtra State FDA Approved Facility Layout

2,300 sq. ft. dedicated laboratory space
Fully air-conditioned environment with continuous UPS power backup protection

Key Analytical Instruments

Thermo Orbitrap, LC-HRMS Q Exactive Plus
Agilent SEC-MALS with RI and viscometer
Thermo Vanquish UHPLC-UV-FLR
Thermo Vanquish HPLC-CAD (Charged Aerosol Detector)
Agilent Capillary Electrophoresis (CE)
Jasco J-1500-CD Spectrophotometer

Shimadzu UV 1900i-Vis Spectrophotometer
Agilent GC-MS 7010D GC/TQ
O-Haus Semi-microbalance with 21 CFR compliant software
Thermo pH Meter with 21 CFR compliant software
-20°C and 2–8°C storage chambers (21 CFR-compliant) with SMS alerts

Key Process Equipments

AKTA PURE – 150L with UNICORN 7
PALL TFF System
3L & 5L Bioreactors

Chromatography & Detection Suite

UHPLC platforms with orthogonal detection technologies enabling robust quantitation, impurity assessment, and method development.

Biophysical Characterization Suite

Integrated HRMS, CE, and CD capabilities supporting structural elucidation, molecular profiling, and advanced analytical studies.

Molecular Integrity & Trace Analysis Suite

Advanced SEC-MALS and GC-MS/MS instrumentation for protein characterization, aggregation assessment, and ultra-sensitive analytical testing.

Accreditations & Regulatory Compliance

Sr. No.	Registration/Accreditation	Department
01	Public testing lab	Maharashtra State FDA/CDSCO approved- Form 37 –Validity till 29/07/2029
02	US FDA Registered	FEI Number: 3038430488 , DUNS Number: 930270205
03	EMEA Registered	𝗢𝗥𝗚 𝗜𝗗: 𝟭𝟬𝟬𝟬𝟱𝟳𝟱𝟵𝟱
04	ISO 9001:2015 Accredited	Quality management system
05	ISO/IEC 17025:2017 Accredited	General requirements for the competence of testing and calibration laboratories

Quality Management System

Quality & Data Integrity Policy

Operating under strict adherence to international regulatory expectations and data governance tenets.

Quality Policy Tenets

Our commitments ensuring excellence across every study deliverable:

✓ Quality & Compliance: Upholding the highest standards of regulatory compliance and data integrity.
✓ Scientific Excellence: Delivering reliable, accurate, and scientifically sound solutions with integrity.
✓ Client Focus: Providing timely, tailored services that consistently meet or exceed expectations.
✓ Competence & Safety: Building a skilled workforce while maintaining a safe, responsible laboratory work environment.
✓ Continuous Improvement: Advancing our processes, technologies, and systems through innovation.

Data Integrity (ALCOA++)

As part of Proantek's commitment to data integrity:

▪ ALCOA++ Compliance: Ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Traceable, and Available.
▪ Secure & Traceable Data: Maintaining absolute data lineage throughout generation, processing, storage, and retrieval.
▪ Controlled Electronic Systems: Using validated platforms with access-level hierarchies, audit trails, and automatic backups.
▪ Culture of Accountability: Continuous personnel GxP training and independent quality-assurance oversight.

Scientific Leadership

Managed by Industry Experts

Decades of biopharmaceutical experience supporting approvals in US, EU, Health Canada, ROW, and India.

Director & Co-Founder

RAKESH SHEKHAWAT, Ph.D.

23+ years of industrial experience in biologics and synthetic peptide analytical, drug product, and drug substance development.
Direct oversight on more than 30 synthetic peptides/polymers and 35 biosimilars including hormones, MAbs, and recombinant proteins.
Supported regulatory dossiers, deficiency responses, and successful approvals across US FDA, EMA (EU), Health Canada, ROW, and India.

Director & Co-Founder

SANKARANARAYANAN SRINIVASAN, Ph.D.

Ph.D. from the University of Texas Health Science Center at Houston, USA; Post-doctoral fellow at Baylor College of Medicine, Houston, USA.
17+ years of combined industrial and academic experience in biologics development, biophysics, and structural characterization.
Author of 11 peer-reviewed international publications (>600 citations) and inventor on 7 international PCT patent applications.

Join Our Scientific Team

We are always seeking analytical chemists, upstream scientists, and regulatory specialists dedicated to precision and data integrity.

Submit CV / Career Inquiry

Let Us Connect

Let Us Discuss Your Development Needs

Whether you are looking for support in process development, analytical development, advanced characterization, formulation development, or CMC & regulatory services, our scientific team is ready to discuss your requirements

Scientific & Business Enquiries: [email protected]
[email protected]

Registered Laboratory Location:

Proantek Research Laboratories Pvt. Ltd.,
Vashi, Navi Mumbai, India

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Reference

Integrated Biologics Development

From Cell Line to Characterized Drug Product