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From Paper Chromatography to Real-Time Biologics

Neo Science Hub by Neo Science Hub
4 weeks ago
in Business Hub, Pharmaceutical & Chemical, Science News
0
Dr. Kripa Murzello, Ph.D. Assistant Vice President & Head, R&D Biologicals, Bharat Serums and Vaccines Limited (BSV) | Mankind Pharma Group
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Dr. Kripa Murzello Maps the Analytical Architecture That Turns Laboratory Science into Patient Outcomes

The AVP and Head of R&D Biologicals at BSV (Mankind Pharma) delivers a methodical, experience-grounded master class at PharmaCore India 2026 on how strategically chosen analytics infrastructure drives every stage of biopharmaceutical development — from discovery bench to clinical bedside, Rashmi Kumari of Neo Science Hub reports from Jio Centre, Mumbai

If Dr. Ratnesh Jain, in the preceding session, made the moral and strategic case for why India must originate new biologics, then Dr. Kripa Murzello, AVP and Head of R&D Biologicals at Bharat Serums and Vaccines Limited — now a Mankind Pharma subsidiary — arrived at the podium to answer a different and equally essential question: once you have the ambition, what does the actual infrastructure of drug development look like? What instruments do you buy? In what sequence? For what purpose? How do you build a laboratory that can carry a molecule from first concept to the clinic — consistently, reproducibly, and at defensible quality?

Her talk, “Integrating Analytics in Biological Development: From Research to Clinical Impact,” was, in the best sense of the term, a practitioner’s master class. Delivered with the unhurried confidence of someone who has spent over two decades building exactly the kind of analytical infrastructure she was describing — from BSV’s R&D biologicals division, one of India’s earliest and most consistently innovative biopharmaceutical R&D operations, active since 1971 and now operating as a Mankind Group company — it provided the audience of scientists, entrepreneurs, and startup founders with something that strategy talks rarely do: a concrete, decision-grade roadmap.

The Historical Arc

Dr. Kripa began, deliberately, in the 1930s — with the first attempts to measure drug levels in biological fluids, and the birth of pharmacokinetics as a discipline. She traced the development of analytical chemistry decade by decade: paper chromatography in the 1940s, thin-layer chromatography following shortly after, ion exchange and affinity chromatography building on those foundations, then HPLC arriving in the 1960s and 70s as the first true high-pressure liquid separation technology, followed by HPLC-MS and, by the 1990s, the liquid chromatography platforms that now sit at the centre of every serious biologics quality control operation.

The history lesson was not nostalgic detour. It was pedagogical strategy. “Many of you will remember from your college days where you started with paper chromatography,” she said, “which was your first introduction to chromatography.” The point she was building toward was that these foundational techniques — apparently archaic — are still part of the curriculum in Indian universities for a reason: they encode the principles that all modern analytical work ultimately stands on. Understanding where instruments come from is prerequisite to understanding why they work, how they fail, and what to do when results are ambiguous.

Parallel to chromatography’s evolution, she mapped the emergence of multi-analyte analysers, flow cytometry, and — most transformatively — next-generation sequencing (NGS), which she identified as the technology that has most significantly reshaped the biologics industry in recent decades and which BSV is now actively deploying across multiple development platforms.

The Four-Stage Framework: Discovery, Preclinical, Manufacturing, Clinical

The organising logic of Dr. Kripa’s presentation was the drug development pipeline itself, and she walked the audience through each stage with the specificity of someone who has navigated all four, not merely read about them.

At the discovery and development stage, the analytical priorities are identity, purity, and structural characterisation — understanding what your molecule actually is, whether it is what you intended to make, and whether its structure is consistent across preparations. The instruments she emphasised here are HPLC systems and UP-HPLC systems for protein separation and purity profiling, mass spectrometry for full molecular characterisation and post-translational modification mapping, and NGS for genomic and transcriptomic insight into targets and mechanisms. On mass spectrometry, she was particularly specific, drawing from BSV’s own experience developing snake venom antiserum — a product whose quality depends entirely on characterising the complex mixture of proteins that constitute the raw material venom: “You need to be able to understand the actual venoms. Venoms are made up of multiple proteins and in order to develop your antibodies, what becomes very critical is actually understanding your raw material. These instruments help in characterising what different proteins are present in your antigen.” It is a concrete example that illuminated a universal principle: in biologics development, analytical rigor on raw materials is not optional quality overhead. It is the foundation on which every downstream decision rests.

At the preclinical stage, the analytical emphasis shifts to stability, metabolism, and biodistribution — evidence that your molecule behaves predictably in a biological system, doesn’t degrade in ways that compromise safety or efficacy, and is reaching the tissues it needs to reach. Here she highlighted a trend that carries significant regulatory and ethical implications: the industry-wide movement away from animal-based assays toward cell-based assays, ELISAs, and other in vitro approaches. Having spent two decades working with equine biologicals — products derived from horses immunised against toxins, a classical biological manufacturing tradition at BSV — Dr. Kripa spoke with unusual credibility on this transition: “I can clearly see a whole shift in the process. We are now moving towards cell-based assays. We are able to reduce the use of animals — and how would this be possible without analytics?”

The implication is important: the reduction of animal use in pharmaceutical development is not merely an ethical aspiration driven by external pressure. It is being enabled, step by step, by the sophistication of analytical alternatives. Without mass spectrometry, without high-throughput cell-based platforms, without advanced ELISA systems, the cell-based paradigm could not function with the sensitivity and reproducibility that regulatory agencies require.

At the manufacturing stage, the analytical infrastructure scales upward in complexity and precision. Dr. Kripa highlighted AKTA systems — automated protein purification platforms — as particularly valuable for laboratory-scale operations. She spoke from personal experience: “I have done manufacturing from the stage where we were filling our own columns and doing manual collections, and then we moved on to AKTA systems.” The transition, she explained, is transformative not merely in efficiency but in data quality: AKTA systems deliver real-time, online analysis, eliminating the overnight-wait model in which a manufacturing error might not be discovered until the following morning, after the process has run its full damaging course.

She was explicit that this principle — real-time data visibility — is among the most strategically significant changes that modern analytical infrastructure has brought to biologics manufacturing. The ability to see your process as it is happening, to identify deviations immediately and intervene before they propagate, is the difference between a quality culture that prevents failures and one that merely documents them.

At the clinical stage, the analytical demands pivot once more — this time toward biomarker identification and quantification, patient sample analysis, and pharmacodynamic monitoring: the evidence that your drug is actually doing what it was designed to do in actual human beings. Here Dr. Kripa emphasised ligand binding assays — surface plasmon resonance, bio-layer interferometry (BLI), octet systems — flow cytometry, multiplexed ELISA platforms, and liquid biopsy technologies, the last of which she identified as an increasingly critical clinical tool for non-invasive disease monitoring and treatment response assessment.

The Instrument Selection Problem: A Practical Corrective

One of the most practically valuable elements of Dr. Kripa’s talk was her frank address of a decision problem that plagues early-stage Indian biotech companies: instrument procurement anxiety. “Many people get scared at the time of costing,” she said. “Instruments are something that are very, very expensive.” Her corrective was methodical: every instrument category she discussed — from basic spectrophotometers to high-end NGS platforms — is available across a spectrum from entry-level to fully configured research-grade. The first decision is not which brand but what your actual analytical need is at your current stage of development. Before purchasing, she recommended detailed consultation with instrument manufacturers and, where possible, access to demonstration systems at supplier locations.

She was equally direct about two hidden costs that are routinely underestimated by laboratory managers: reagent costs and consumable plasticware costs for high-throughput multiplexed systems. These recurring expenditures, she cautioned, can dwarf the capital cost of the instrument itself, making multiplexed automated platforms economically viable only when sample volumes are consistently high and workflows are continuous. “If you are very sure you are going to use it continuously — then invest. Otherwise, it is a waste.”

This kind of institutionally earned practical wisdom — unsentimental, specific, and grounded in the actual economics of running a biologics R&D operation — is rarely heard in academic forums and even more rarely from speakers at senior industry positions. It was evidently appreciated: Dr. Uma Raghuram, the session chair from Spinco Biotech, characterised the talk as “back to basics, fast and furious” — a summation that captures both its velocity and its grounding in foundational principle.

The Collaboration Imperative

Dr. Kripa echoed and reinforced one of Dr. Jain’s central themes from the preceding session: the critical importance of industry-academia collaboration. Noting that many startups have exceptional capabilities but lack the resources to acquire high-end analytical instruments, she encouraged the audience to approach established companies and research institutions for collaborative access rather than viewing instrument costs as barriers to entry. “It is a very small investment,” she said. “You are able to carry out your experiments, get your results, and you don’t bear the cost yourself.” Her professional reputation, built over two decades at BSV, is characterised by colleagues as that of someone who leads by scientific example and is consistently open to collaboration across institutional boundaries.

The Central Thesis: Analytics Is Not a Support Function

Dr. Kripa’s closing argument was as direct as it was important: analytics is not the support function that biology departments have traditionally treated it as. It is the spine of the entire drug development enterprise. “Without analytics you are not able to do anything. Analytics is something which has completely changed biologics itself — and it is used from discovery all the way to clinical phase.” The key outcomes she ascribed to integrated analytical strategy: enhanced molecular process understanding, real-time data for decision-making, acceleration of development timelines, improved product quality, safety, and regulatory compliance. Above all: the ability to bridge research to the clinic — to ensure that what is developed in the laboratory does not stop at the laboratory, but reaches the patient for whom it was developed.

Contextual Significance: The PharmaCore Moment

Taken together, the two morning sessions of the Powering Biopharma track at PharmaCore India 2026 constitute a genuinely coherent programme. Dr. Jain established the strategic landscape — the biological opportunity in rare disease and oncology, the $800 billion global market by 2030, the gaps in Indian IND filing, ADC and bispecific capability, and the talent crisis in CMC biology. Dr. Kripa then provided the operational architecture — the instruments, the decision frameworks, the stage-by-stage analytical logic that turns a scientific hypothesis into a clinical candidate. One set the ambition; the other drew the blueprint. For the entrepreneurs, startup founders, and MSME pharma executives in the audience, it amounted to a remarkably complete afternoon’s education in what building a biologics development operation in India actually requires. Bharat Serums and Vaccines, now operating as a Mankind Group company, has been developing biological products since 1971 — a legacy that Dr. Kripa carries forward not as institutional weight, but as a living body of operational knowledge. That, ultimately, is what distinguished this session: not the presentation of an ideal, but the transmission of hard-won practice.


SPEAKER PROFILE
Dr. Kripa Murzello, Ph.D. Assistant Vice President & Head, R&D Biologicals, Bharat Serums and Vaccines Limited (BSV) | Mankind Pharma Group Experience: 20+ years in biopharmaceutical R&D | Specialisations: Immunology, biotechnology, equine biologicals, cell culture, critical care therapeutics Education: PhD (Biochemistry), GS Medical College, KEM University, Mumbai; M.Sc. Zoology & Biotechnology Areas of focus: Analytical method development, process optimisation, clinical translation, biologics quality systems


KEY ANALYTICAL PLATFORMS COVERED IN THE SESSION
HPLC / UP-HPLC (purity, separation, stability) | Mass spectrometry (protein characterisation, PTM mapping, biomarker discovery) | Next-generation sequencing (genomics, transcriptomics, functional genomics) | Multiplexed ELISA / AlphaLISA systems (high-throughput biomarker and clinical sample analysis) | AKTA / FPLC systems (protein purification, process development) | Ligand binding assays — SPR, BLI, Octet (binding kinetics, affinity studies) | Flow cytometry (cell-based assays, immunophenotyping, CD marker studies) | Liquid biopsy platforms (clinical monitoring, diagnostic profiling)


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