Plasma Fraction offers a complete, end-to-end model that enables clients to move seamlessly from lab scale to commercial scale (1L liters to 3L liters Per Annum) production, aligned with global demand for Human Albumin and Immunoglobulin (IVIG) in IP and BP grades.

Key Strengths:

• Hands-on Experience: Successfully operating a validated plasma fractionation facility.

• Optimized Processes: Continuous improvement in handling raw materials, resins, and process equipment.

• Risk-Free Setup: Elimination of design errors, incorrect equipment selection, and cost overruns.

• Cost Efficiency: Comparable facilities often cost nearly 100% more — our model ensures the best CAPEX optimization.

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25+ Years of Biopharma Excellence

We bring over 25 years of collective experience in biopharma CRO and CMO operations, with a proven track record in biologics technical operations, biosimilars, and plasma-derived products.

Our team has contributed to the development, validation, and commercial manufacturing of more than 30 biologics, including:

• Plasma-derived medicinal products (PDMPs)

• Novel biologics and biosimilars (recombinant proteins & monoclonal antibodies)

• Research-use-only and clinical-stage biologics

We have led global-scale product launches in both highly regulated and emerging markets, taking responsibility for end-to-end development — from lab to market.

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Global Leadership Experience

Our leadership team has held strategic and technical positions across two continents (US and India) at organizations such as:
Invitrogen (Thermo Fisher Scientific), Lonza, KAUST, Scigen, and USV.

This global exposure has shaped our ability to integrate international best practices, regulatory compliance, and cost-efficient solutions tailored to diverse market needs.

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Generic Drug Development & Regulatory Expertise

One of our senior team members brings over 21 years of experience in the development of 150+ generic formulations for USFDA, EU, TGA, Med safe, MCC, and other international markets.

This includes:

• Experience with Corerx Pharma (USA) and collaborations with major Pharma companies in India.

• Full-cycle management of product development:

  • Drug substance sourcing

  • Analytical method development and validation

  • Manufacturing of exhibit batches

  • Clinical bio studies

  • Filing of ANDAs in eCTD format via ESG to the USFDA

• Expertise in commercial launches of generic products in the US market

We are adept in regulatory submissions, ANDA filings, and post-approval lifecycle management, ensuring compliance across multiple jurisdictions.

 

Regulatory, QA & QC Leadership

Our team has successfully managed USFDA, Health Canada, and MHRA audits, and established research and development centers with integrated quality systems.

We have extensive experience in:

• Initial drug firm registration and electronic submission gateway (ESG) setup

• eCTD software management, CDER Direct registration, and annual renewals

• Preparation and submission of eDRL (Drug Listing) post-ANDA approval

• Authoring and maintaining regulatory documentation for diverse dosage forms

• Managing post-approval changes and product lifecycle variations

This ensures our clients’ facilities and documentation are always inspection-ready and globally compliant.

 

PDMP Process & Facility Expertise

Plasma Fraction has designed and implemented controlled processing units for PDMPs, handling up to 22,000 liters of fresh frozen plasma per month.

Our expertise includes:

• Tailor-made equipment selection and installation

• Process documentation, validation, and qualification

• Chromatography-based fractionation systems for higher yield and product purity

• Technology transfer and operational optimization

Our technical team comprises scientists, engineers, PhD holders, and medical professionals specializing in plasma fractionation, Human Albumin, and Immunoglobulin (IVIG) manufacturing.

 

Organizational Strength

We take pride in building strong organizations grounded in:

• Technical problem-solving and innovation

• People leadership and skill development

• Technology transfer and knowledge management

• Continuous improvement and GMP compliance

 

Core Focus Areas

Plasma Fraction’s operations span across all critical areas of modern plasma-derived product manufacturing:

• Plasma Fractionation Process Development

• Facility Layout & GMP Compliance Design

• Equipment Selection & Integration

• Automation and Digital Traceability Systems (SCADA/MES)

• Regulatory Dossier Preparation & Validation

• Commercialization and Tech Transfer Support