Pristine Biosciences
Analytical CMC consulting · Potency & bioassay services
Backed by more than 20 years of experience in biopharma, Pristine Biosciences provides phase-appropriate analytical strategy and hands-on bioassay expertise for biopharma programs moving from discovery and preclinical development through IND and Phase 1–2, from small molecules to advanced therapies.
Discovery
Cell-based screening strategy
Preclinical
Methods, CQAs & potency design
IND
Specifications & CMC sections
Phase 1–2
Release, stability & oversight
Consulting services
Our consulting is organized into six practice areas, each covering the full set of activities your program needs.
01
Phase-appropriate release specifications
Specifications for drug substance and drug product aligned with critical quality attributes, with performance assessed through data trending.
In-process testing
Strategy for in-process controls and testing that monitor critical steps and support consistent product quality.
Lot release review
Review of release data packages and certificates of analysis before lots are dispositioned.
02
Stability program design
ICH-aligned programs for drug substance and drug product: storage conditions, time points and testing schedules.
Forced degradation studies
Study planning and review that demonstrate your methods are stability-indicating.
Stability data & trend review
Early detection of quality issues and evidence for shelf-life and retest-period proposals.
Cost-effective stability-indicating assays
A phase-appropriate assay strategy, so you only invest what each stage actually needs.
03
Method readiness assessment
Is each method fit for GMP release? Practical plans for early clinical use.
Method development, qualification & validation
Design and oversight of studies, acceptance criteria and reports per ICH Q2(R2) and Q14.
Method transfer
Protocols, acceptance criteria and report review for transfers to and from CDMOs and contract labs.
04
Vendor selection
Scope definition and capability reviews to choose qualified analytical partners.
Method transfer oversight
Independent oversight of transfers so methods perform at your partner as they did at the source.
Your QC representative
Study plan and data review so vendors deliver reliable, inspection-ready results.
05
Deviation investigations
Structured investigations of laboratory and testing deviations.
OOS & OOT investigations
Out-of-specification and out-of-trend results, from lab assessment to full investigation.
Root cause & impact assessment
Science-based root cause analysis and product impact assessment.
CAPA
Corrective and preventive actions that stop issues from coming back.
06
MoA-driven potency strategy
A phase-appropriate potency assay matrix with a reference standard plan.
Characterization strategy
Structure, function, variants and impurities, supporting CQAs and comparability.
IND CMC analytical sections
Preparation and review of specifications, analytical procedures, method qualification, batch analyses and stability.
Reduce development costs. We help reduce development costs with a phase-appropriate strategy for method qualification, validation and stability-indicating assays, so you only invest what each stage actually needs.
Research & development
Senior guidance for hit-to-lead work, so your team advances the right hits with confidence, using discovery assays built to become your future potency methods.
Screening cascade strategy
MoA-driven funnel with clear go/no-go criteria
Assay design & selection
Right cell models, readouts and plate formats
Data-quality review
Technical data review and good documentation practices
Hit triage & prioritization
Objective, data-driven series recommendations
CRO selection & oversight
Scope, study review and monitoring
Troubleshooting & rescue
Fix noisy, drifting or failing assays fast
Laboratory services Coming next
Mechanism-of-action-driven assays for research and clinical-stage programs, developed and qualified per ICH guidelines, from first feasibility to transfer-ready methods.
Cell-based potency and activity assays (non-GMP)
qPCR and PCR-based assays, plus more plate and cell-based assays
Flow cytometry-based assay solutions
In practice
Representative scenarios, not client case studies.
Pre-IND
Define an MoA-based potency strategy, a qualified interim assay and a reference standard plan in time for the IND.
Phase 1
Trend the data, lead the investigation with the vendor, and put method and specification fixes in place.
Phase 1–2
Design an ICH-aligned stability program and forced degradation studies that prove methods are stability-indicating.
Our expertise
20+
years of combined experience across academic research and the pharmaceutical and biotech industry
Niraj Bhatt, PhD
Founder & Principal Consultant · 20+ years in biopharma: PhD in biochemistry, six years of postdoctoral research, and 10+ years of pharma and biotech QC leadership
What regulators expect at each stage, without unnecessary spend.
Objective oversight of your CDMOs and contract labs.
Documentation and statistics built to stand up to FDA review.
Readiness assessments, defined projects or a fractional QC lead.
Meet the founder
Founder & Principal Consultant, Pristine Biosciences
Dr. Niraj Bhatt is the Founder and Principal Consultant of Pristine Biosciences, which he established to give emerging biopharma companies direct access to phase-appropriate analytical and quality expertise. With more than 20 years of biopharma experience spanning drug discovery, contract research and quality control for cell therapy manufacturing, Dr. Bhatt helps clients move programs from preclinical development through IND and Phase 1–2 with confidence.
His consulting focuses on release and stability testing, method development through validation, potency and bioassay strategy, deviations and CAPA, IND CMC documentation, and the selection and oversight of CDMOs and contract laboratories. Having worked on both the sponsor and CRO sides of the industry, he brings a practical, cost-conscious approach that balances regulatory expectations with each program’s stage and budget.
CRISPR Therapeutics
At CRISPR Therapeutics, Dr. Bhatt built and led Quality Control for gene-edited CAR-T cell therapy manufacturing, gaining hands-on experience with the challenges clients face on the path from IND to the clinic. He developed the QC readiness strategy for in-process, release and stability testing that supported 12 GMP batches in a single year, led nine method transfer and qualification activities, and oversaw contract testing laboratory partners. He owned deviations, investigations and change controls, authored IND CMC sections, and implemented LIMS for sample management. He also delivered approximately $2 million in savings through risk-based, phase-appropriate redesigns of qualification and stability programs.
Charles River Laboratories
As a Study Director at Charles River Laboratories, a leading global CRO, Dr. Bhatt led GLP cell-based bioassay studies, including cytokine release and ELISpot assays, for cell therapy products such as CAR-T cells and CD34⁺ stem cells. He designed, drafted and reviewed analytical methods, gaining direct insight into how contract laboratories plan, execute and report studies for sponsors.
PPD (now part of Thermo Fisher Scientific)
At PPD, another leading global CRO, Dr. Bhatt served as a Technical Project Manager and primary client contact, managing multiple cGMP potency assay programs for biosimilars and antibody-drug conjugates using cell-based potency assays. He led method qualification and optimization to ICH and USP standards and authored investigations, deviations, trend analyses, CAPAs and change controls, while consistently meeting turnaround targets. This CRO-side experience informs how he now selects and oversees contract laboratories for clients.
Sun Pharma Advanced Research Company
Dr. Bhatt began his career in drug discovery at Sun Pharma Advanced Research Company, part of one of India’s leading pharmaceutical companies. There he designed efficacy screens for new chemical entities and established 13 disease-relevant animal models to characterize efficacy, safety, toxicity and PK/PD relationships. His hit-to-lead work contributed to an IND for a molecule that advanced to Phase II clinical trials.
Dr. Bhatt completed six years of postdoctoral research at Johns Hopkins University School of Medicine and the University of Maryland, Baltimore, where he developed new cell-based models and assays.
Division of Cardiology, Johns Hopkins University
His first postdoctoral project focused on restoring heart function in diabetes. He showed that oxidative stress disrupts the redox balance of heart muscle and reduces its contractility, and that restoring redox balance improves cardiac function.
Department of Radiation Oncology, Johns Hopkins University
His second postdoctoral project focused on patient-derived stem cells for a rare disease. He established the lab’s first induced pluripotent stem cell (iPSC) program, developing an integration-free method to reprogram patients’ blood cells into iPSCs as a disease model for Ataxia-Telangiectasia.
University of Maryland, Baltimore
He studied energy production in brain cells, investigating mitochondrial bioenergetics and drug mechanism of action in astrocytes and microglia under physiological oxygen and proinflammatory conditions. His work addressed whether shifting the metabolism of microglial cells could reduce inflammation in the brain. He also established siRNA and immunohistochemistry methods in the lab.
Contact
Tell us about your molecule and stage, and we’ll set up a 30-minute consultation.
[Phone number]
Greater Boston, Massachusetts
Occasional notes on potency, stability and regulatory expectations.