Lab to T ab - himedialabs.com

ACCESS TO INTERESTING BIOSCIENCES STORIES FROM YOUR TAB - A HiMedia Newsletter

™Lab to T ab

MICROBIOLOGY ANIMAL CELLCULTURE

PLANT TISSUECULTURE

HYDROPONICSSOILLESS FARMING

MOLECULARBIOLOGY

CHEMICALS &BIOCHEMICALS

LAB AIDS &INSTRUMENTATION

80 and Ahead :Dr. G. M. Warke,The Father of IndianMicrobiology BusinessEnters theOctogenarian Club

A HiMedia NewsletterVolume -12, September 2021

HiMedia Laboratories Pvt. Ltd.himedialabs.com

■ Science Galaxy : Indian Biopharmaceutical Industry - A Way ForwardIN

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Lab to TabTM | Newsletter Volume - 12

HiMedia Laboratories Pvt. Ltd. | himedialabs.com 3

C NTENTSMessage from the CMD - Dr. G. M. Warke

The Science Galaxy - Indian Biopharmaceutical Industry: Way Forward - Dr. Mirage Singh

80 and Ahead : Dr. G. M. Warke - A Cover Story - Ms. Dipanwita Chakraborty

Creating Molecular Footprints - Dr. Kavita Khadke

HiMedia- ATCC Referral ChainProgramme

Plant Tissue Culture - Elicitor For Production Of Bioactive Compounds - Siddharth Pore

CROSSIT - The crossword of HiMedia

Microbiology : Changing Horizons In Microbial Diagnosis - Dr. Santosh Kaul

Importance Of Ig Based Diagnosis For Covid-19 - Dr. Manjusha Rani & Dr. Priyanka Majumder

HiMedia Laboratories Pvt. Ltd. | himedialabs.com

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Lab to TabTM | Newsletter Volume - 12 2

MESSAGE FROM THE CMD


Dear All,

As we move forward through the pandemic, expressing gratitude has become even more important than ever.

The past year and half made me realize more how fortunate I am, to be able to work with a team that never digresses from giving anything less than 200%. Even when the medical infrastructure of the nation was crippling under the impact of second wave, followed by the black fungus epidemic, HiMedia’s teams rallied beside each other, engrossed in extensive research, for the sake of rolling out diagnostic kits and equipment.

I am deeply humbled and thank each and every member of team HiMedia for their continued contribution towards respective teams; working hard, making significant differences and simultaneously managing personal situations. This will, forever remain etched in my memory.

The resurgence of second wave of COVID-19 also brought the deadly Mucormycosis epidemic along. In order to support and contribute to the nation’s healthcare infrastructure, HiMedia worked extensively and developed a unique formulation of HiFungalTM Transport Medium Kit – Muco-diagnoTM (K144). This kit is a complete one-stop easy solution for clinicians to isolate causative fungi from mucormycosis patients, one-of-its-kind in the Indian market.

The pure fungal cultures so obtained from the patients, can be used further for detailed taxonomy studies and antifungal profiling to decide the exact line of antifungal therapy.

In addition to this, we continue to offer our COVID-19 package which includes - VTM Kits with swabs, Virus Inactivation Medium, ELISA antibody detection kit, Viral RNA Purification Kit- Magnetic bead based, automated nucleic acid extraction, pre-filled plates for Mag series, COVID-19 multiplex probe PCR kit.

We aim to provide maximum support to all essential services including vaccine manufacturers, pharmaceutical, hospitals, clinical set-ups, healthcare, diagnostics and food industry through our range of bioscience products.

In this special edition of our newsletter, we bring to you interesting reads from team HiMedia on developments within the Indian biotechnology industry. In the science galaxy section, we are honoured to have Dr. Mirage Singh, Program Manager, National Biopharma Mission, Department of Biotechnology, Ministry of Science and Technology who sheds light on biotherapeutic industry and possible interventions for promoting novel biological molecules.

Wishing you happy reading!

Dr. G. M. Warke, Ph.D.Founder & CMD - HiMedia Laboratories Pvt. Ltd.


The Science Galaxy

INDIAN BIOPHARMACEUTICAL INDUSTRY: A WAY FORWARDBy Dr. Mirage Singh

Dr. Mirage Singh, PhD,Program Manager, National Biopharma Mission, DBT

Dr. Mirage Singh is currently working as Program Manager with National Biopharma Mission, a joint program of Department of Biotechnology, Ministry of Science and Technology, Government of India and World Bank to strengthen the ecosystem for biopharmaceutical and healthcare research and accelerated product development in India

Dr. Mirage Singh is PhD in Biochemistry and structural biology from Institute of Microbial Technology, Chandigarh and possess more than a decade’s experience in research and development in the area of protein structure function relationship, structure based drug designing, development of biosimilar products. He has a rich experience of working in academia and Industry. Dr. Singh has worked with many GLP accredited laboratories and cGMP manufacturing facilities to establish the quality management system in these facilities. Dr. Singh is managing a portfolio of 30 different biosimilar products and establishment of GLP analytical and cGMP biological manufacturing facilities along with state of art cell line repositories in India.

Dr. Singh is also focusing on projects for indigenous development of novel and next generation biomolecules along with indigenous development of various raw materials and consumables required for biomanufacturing of biopharmaceuticals in the country.


Biotherapeutic Industry: Brief Background

Despite of inherent complexities in their manufacturing, longer product development timelines, huge CapEx investments, biologics are gaining momentum throughout the world because of their huge potential in addressing the unmet medical needs. Since the COVID-19 pandemic has struck the humankind, the role biologics can play to address the healthcare problems have been realized in a bigger way than ever before.

In a recent report published by ABLE, biologics including biotherapeutics and vaccines contribute about ~ 27 % in a bioeconomy of ~ 70 billion USD in India. Today, when the global biologics economy is at ~ 320 billion USD, India’s contribution to global economy needs to be increased, (https://birac.nic.in/webcontent/1615182060_Indian_BioEconomy_Report_2021.pdf).

Novel Biotherapeutics

Since the approval of its first biosimilar in early 2000, India has more than 200 biosimilars/ biotherapeutics approved in the country. Moreover, the biosimilars from India have started to register presence in the global markets including EU and

United states. However a concerning factor which might play a bottleneck in realizing the anticipated growth of biotherapeutic sector is lack of novel molecules in the pipeline of Indian biologicals developers.

(https://birac.nic.in/webcontent/Knowledge_Paper_Clarivate_ABLE_BIO_2019.pdf)

The potential of innovative biologicals and the huge market share they offer is evident from the annual sales of drugs like Adalimumab and Pembrolizumb at ~20 billion USD each. At a time, when we are looking at the ways to make biotherapeutic drugs more affordable in India through large scale production of biosimilars, we also need to focus our attention on the interventions to promote novel molecule development in India to achieve the desired economic growth in the sector.

Possible Interventions for Promoting Novel Biological Molecule

Development of novel biologics is a lengthier and costlier process with less success rate than biosimilars. Due to the risk involved, few companies are venturing into development of novel biologics. India has to offer more in this segment owing to great


BRING PRODUCTS CLOSER TO MARKET• Relevant to the public health - India specific• Low cost

BRIDGE CRITICAL GAPS• Aid products in pipeline• Enhance capabilities to develop novel• Enhance outsourcing capabilities

ENHANCING ACCESS TO TECHNOLOGIES• Build an IP driven bio-economy• Building regional competencies and

enhancing bio clusters ecosystem

BUILD HUMAN RESOURCE• Generation nest-generation of trainers,

leaders and developing a skilled workforce

Product Development

Capacity Development

Specific Products

Shared Infrastructure

Skill Development

Technology Transfer

Figure 1: Interventions through National Biopharma Mission for accelerated and affordable product development

scientific potential and laboratory infrastructure in national research institutes and industry.

Government is playing a proactive role in promoting the expansion of novel biologics by fostering an enabling ecosystem for development of novel biologics entities in the country. Through focused programs like National Biopharma Mission (https://birac.nic.in/nbm/) introduced in 2017, grant funding is being provided for development of biologics product (biosimilars and novel biologics) and establishment of shared facilities like GLP analytical labs, process development labs, immunogenicity and cell line repositories to allow for affordable product development.

While National Biopharma Mission has played an important role in strengthening the ecosystem and initiating funding for novel biological development, more interventions are required to set the right pace for novel biological development in the country. Grant funding for financial risk mitigation in academia and industry R&D to specifically take on the next generation biomolecules is need of the hour. Dedicated fund allocation for translational research and setting the mandate for research institute of national repute for early phase research and development will attract Indian biopharmaceutical manufacturers and foster Industry-academia partnership.


80 and Ahead: Dr. G. M. Warke, The Father of Indian microbiology Business enters the octogenarian club

COVER STORY

Legacies are created out of the marks made in pursuit of putting a positive

spin on things with diligent handling of fragile situations, time and again.

In the thick of several events unfolding simultaneously at the Mumbai Headquarters of HiMedia Laboratories, the Indian Bioscience giant, it’s our CMD, Dr. Gangadhar M. Warke, who, even after being at the helm of all affairs, walks around with an air of calm in his mien. He would have turned 80 by the time you read this and till date, no one can beat him in being a true personification of leadership. He is the only person in HiMedia who works 365 days a year, without taking a single vacation and yet gleams with enthusiasm when talking about new innovations and potential opportunities through which HiMedia can contribute to nation’s economy.

He had set his heart on his personal quest to establish a brand that spoke ‘Make in India’ out loud and clear, far in advance, decades before it started trending as a twitter hashtag. Today, almost 5 decades, 2 international offices and 150 countries later, brand HiMedia continuously endeavors to be the global leader in world-class quality products. All his efforts, determination and resilience paid off when HiMedia was ranked among the top 3 media manufacturers in the world by the American Society of Microbiology (ref- Handbook of Microbiology Media, 4th Edition, Prof. Ronald Atlas, ASM, CRC press).

“This is the kind of recognition that drives us every single day to make science easy and lives easier. We have already shifted the game towards India’s favour by spreading our footprints in over 150 countries where our products are exported. These countries include some of the most technology driven nations like Japan, Germany, USA, etc.” Dr. Gangadhar M. Warke

Starting With Brand HiMedia – Moving Beyond Hurdles

When he started his journey of making Microbiological media to help the Indian scientific fraternity from his kitchen back in 1974, little did Dr. G. M. Warke imagine the monumental effect his humble venture would have on the future generation scientists and on the country’s economy alike. The major breakthrough came in when HiMedia successfully manufactured the Dehydrated Culture Media (DCM) products using its indigenous technology, thus breaking the monopolies of multinationals in UK, US and Germany. This is the time when HiMedia made its presence felt on the global platform, being the only Indian manufacturer of these products. India became the 4th country in the world for specializing in manufacture of dehydrated culture media products.

There were quite a few challenges that Dr. Warke faced from researching on the technicalities in manufacturing various recipes to develop that


perfect culture medium to getting approvals and obtaining requisite licences from the government offices after multiple visits to financial hassles while procuring raw materials since the dealers would not provide material on credit to a new company. Dr. Warke had to purchase every bit by paying cash, sometimes, by borrowing money from friends and relatives.

Nevertheless, none of those initial challenges, rejections and set-backs could manage to dwindle his determination to warrant an Indian firm’s entry into a field that no one thought was possible. His efforts to develop and manufacture dehydrated culture media indigenously in India were questioned by a world’s leading producer of the products. Dr. Warke took up the challenge and proved his naysayers wrong when he successfully developed his first batch of culture media and got quality approved by one of India’s best quality labs.

In less than 2 decades after its establishment, HiMedia’s products became a dependable name among India’s premier scientific and research institutions like AIIMS, PGI, CCMB, IARI, CDRI, CRI and Indian arms of trans-nationals like Roche, GM, Hoechst, May & Baker, to name a few. The company’s reach extended till Dakshin Gangotri,

India’s permanent research station in Antarctica, where products of HiMedia were used for detection of dormant bacteria in the sub-zero environments.

Evolving Into Novel Biosciences

As of today, Dr. Warke has spearheaded the company’s evolution from a Microbiology media manufacturing company to a fully integrated Bioscience company with a vast product portfolio spanning across 7 businesses namely, Microbiology, Animal Cell Culture, Molecular Biology, Plant Tissue Culture, Chemicals & Biochemicals, Lab Aids and Hydroponics. Under his leadership, team HiMedia is working towards opportunities in portfolio expansion within pharmaceutical, healthcare, food & brewery, and diagnostics industries.

The Microbiology portfolio has been further expanded to an entire range of ready-prepared media, and a complete line of animal free culture media and ingredients under the brand name HiVegTM which are used by several biopharmaceutical and vaccine manufacturers worldwide.

The Animal Cell Culture business has set up a world-class upstream media development and bioprocess

Best Company of The Year 2019

(Research & Innovation)

Brand Ambassador of Maharashtra

2019 (Research & Innovation)

Contribution to Hospital Infection

Society India HISICON 2019

BioSpectrum Excellence Award Biosupplier Industry

Leader 2020


Ms. Dipanwita Chakraborty,AM - Brand Communications & Digital Marketing

80 and AheadEven at 80, Dr. G. M. Warke enthusiastically involves himself in understanding the nitty gritty of all 7 businesses which are being headed by the cohort of second generation scientists in the family. As the world has now embraced digitisation, Dr. Warke too, becomes elated while trying to understand the know-how of the virtual media which keeps changing on per diem basis.

Dr. Warke often quotes “Ever since microbiologists Robert Koch and Louis Pasteur made the mankind aware of microbes, humankind has come a long way in its efforts to tame the microbe and employ them to enrich lives on the planet.”

optimization lab for biosimilars. HiMedia is further working on development of media for storage and transportation of organs including products to support stem cell and gene therapy.

In additional to developing a comprehensive molecular diagnostic platform for COVID-19 detection, HiMedia’s Molecular Biology business plans to unravel the untouched space of intuitive medicine by means of PCR based detection of anti-microbial markers to help clinicians to decide their drug of choice. To help foster better healthcare infrastructure for the country, instilling point-of-care testing platforms would expand their presence at grassroots levels.

The hydroponics business, which goes by the name Higronics® is all set to lead the soil-less home and urban farming space in metros. HiMedia is the pioneer in providing hydroponic turnkey solutions with special focus on technology and innovation when it comes to formulating crop specific hydroponics nutrient solutions. This soil-less farming technology is the newest venture that Dr. Warke has entered into.

Accolades

Dr. Warke has never sought status or recognition and has continuously remained focused on serving the scientific community. He was honored as ‘Brand Ambassador of Maharashtra’ in the category of research and innovation by Maharashtra Industrial and Economic Development Association (MIEDA), whereas, HiMedia was ranked as ‘Best Company of the Year 2018’ in ‘Pride of Maharashtra’ award series.

Brand HiMedia has been felicitated as a first ranking unit from Nashik, Dindori Taluka for ‘Make-in-Maharashtra’ and ‘Make-in-India’ in the Maharashtra Investment Seminar 2016, by Honourable CM, Shri Phadanvis. HiMedia also received prestigious Rajiv Gandhi National Quality Award by Bureau of Indian Standards, India for quality services to the consumer in 2011 and Rajiv Gandhi National Quality Award Bureau of Indian Standards, India in 2006.

Another addition to his existing long list of awards and recognitions he has been conferred with throughout his journey of 48 years is the ‘Bio Supplier Industry Leader of the Year Award 2020’ by BioSpectrum.

True leaders are people who lead by example, shift narratives towards something positive and impactful, by adapting to circumstances and dare to think out of the box. Dr. Gangadhar M. Warke is the best example of one such leader that posterity would always pay tribute to.


The field of Molecular Biology has evolved

at a record pace with the introduction of newer techniques and increased applications across various fields.

Evolution in gene based technologies has propelled molecular diagnostics to new dimensions, thus highlighting its importance in the healthcare industry. Traditional culture-based screening tests that require days together have now been replaced by molecular tools that have emerged as a more specific, sensitive, less time consuming and user-friendly alternative.

Along with the need for reliable and accurate results, Molecular Biology has also been augmented by the scope for automation of techniques and procedures. Advances in molecular diagnostics and the ability to automate the processes involved have the power to move the lab to the front lines of medicine more efficiently and cost-effectively. Complete workflow in a molecular lab that typically begins with sample preparation followed by nucleic acid extraction and then Polymerase Chain Reaction (PCR) that took 2-3 days for completion by traditional methods can now be performed in a few hours; the key is automation. Automation is essential for systematic, smooth and streamlined molecular testing. While manual methods are labour-intensive and error prone, especially due to the possibility of cross-

CREATINGMOLECULAR FOOTPRINTS

contamination, use of instruments allows simplified operation, larger testing

capacity with lesser turnaround time and sets the lab personnel free to focus on tasks demanding human intervention which involves

result analysis, troubleshooting experiments and studying basic functional aspects of the assays performed in the lab.

HiGenoMB® now has a dedicated section offering extremely versatile and

compact bench-top models of Molecular Biology

instruments apt for all kinds of molecular lab set up. The journey began with the introduction of the Prima® series of conventional PCR systems to suit all needs of a basic PCR.

Our range of affordable solution also includes the TabSpin™ Centrifuge, Hi-Gel Electrophoresis assembly and Hi-UV® Transilluminators for easy end-point analysis of Semi quantitative PCRs. The Wee® PCR machines are the ultra-light and portable Semi-Q PCR systems that also fit perfectly well in any kind of mobile lab facility.

The growing need for PCR based testing, especially in the healthcare sector resulted in the launch of the highly efficient Insta Q96® and Insta Q48® Thermal cyclers. Integrated real-time detection


systems with competent and user-friendly software, a must-have for standardized and simplified qPCR assays. The next milestone was the introduction of Insta NX®, an automated nucleic acid extractor that is based on a very unique Super – S column technology for isolation of DNA and RNA from various types of samples. It is a completely automated and extremely robust instrument that lets one avoid manual handling of samples.

Need of the hour being a high throughput solution for DNA and RNA extraction, HiGenoMB® recently launched the Insta NX® Mag series of Magnetic Bead Based Extraction systems.

In the current pandemic situation, the Insta NX® Mag32 and Mag96 have fetched importance like no other. With the Mag96 instrument having maximum sample capacity of 96 and pre-fed protocols for the quickest Viral RNA extraction, viz. 11

minutes, HiMedia has been the only Indian manufacturer to put plenty of clinicians

at ease by

providing a complete automated solution for detection of the COVID-19. It is this simplified automation and not just automation that has helped garner customer loyalty. The service driven approach of the instrumentation team has helped them ensure round the clock complaint solving and troubleshooting. HigenoMB adds value to India’s Technology Paradigm in the LifeSciences and Biological Academia by contributing in empowering researchers with state-of-the-art instrumentation thus glorifying and enhancing their research work at the global scale.

As India is now at the brink of involving automation for routine work flow, HiMedia is here to cater to your requirements of automation for complete Molecular Biology workflow from extraction of Nucleic acid to Real-time PCR. HiMedia strongly works on product customization so as to build a good customer relationship.

The RnD team at HiGenoMB has been successful in bringing up tailormade solutions to meet customer requirements with products such as the pre-filled plates and superfast protocols that resonate with the innovative, out of the box thinking that HiMedia has always nurtured to bring in fresh and need of the hour outlook into the Molecular diagnostic arena.

Dr. Kavita Khadke,Director -Molecular Biology


HIMEDIA- ATCC REFERRAL CHAIN PROGRAMME

Representative images of rewards

At the outset, we would like to thank you all for using ATCC products through us.

In view of this, we are introducing the HiMedia- ATCC Referral Chain Programme, as a gesture of gratitude towards our eminent customers.

HiMedia is a privileged partner of ATCC for supply of global biological material resources for our Indian customers providing products, services, and technical support also.

A a first step of this HiMedia- ATCC Referral Chain Programme is to get your valuable feedback in terms of technical support, supply, and services etc which will help us in our endeavour of continuous improvement to serve you better.

Only our existing HiMedia- ATCC customers will

be eligible to participate in the same. Our valued ATCC customer must provide us with referral, and they will be provided a token of appreciation upon generation of the first ATCC order from the referred person.

Please get in touch with our marketing executives to know more about the programme details.


Plantae, as vast as a kingdom it is, has provided boundless natural products

with diverse biological activities which are used to solve the problems of the mankind.

Bioactive compounds are the secondary metabolites produced by the plants eliciting pharmacological or toxicological effect on living organisms. Majority of the plant species produce such compounds which get scientifically evaluated for their potential application in various fields of life sciences. The major classes include glycosides, flavonoids, tannins, alkaloids, terpenes and saponins.

The economic importance of bioactive compounds led to an inevitable collection of plants from their natural habitat, thereby creating an instability in the biome which pinched the scientists to develop alternate techniques to preserve the flora in their respective habitat.

One of such leading techniques is plant tissue

PLANT TISSUE CULTURE, AS AN ELICITOR FOR PRODUCTION OF BIOACTIVE COMPOUNDS

culture, showing promising results in the production of bioactive compounds for commercial application, as it surpasses the environmental and seasonal constraints for bulk propagation of plants.

Evolve with the evolving…

As plant tissue culture is evolving by paving its way through various fields of medical science, the techniques are also getting evolved to produce more efficient results.

Studies suggest use of callus over other plant materials collected from the wild for producing therapeutic metabolites as it is a more reliable source for the generation of multiple clones of plants and developing single-cell suspension cultures for production of the preferred compound.

One of the most interesting techniques involves the use of elicitors especially for compounds that are difficult to isolate. Elicitors are certain chemical agents or factors that are responsible for activating the defence system of the target living organism, which in this case are plants, inducing expression of specific genes for production of secondary

Elicitors

BacterialFungal

PolysaccharideYeast extract

Physical - UV, Thermal stress, Drought, Salinity, Osmotic stressChemical - Heavy metals, Mineral salts Hormonal

Biotic

Abiotic


metabolites. They can be either biotic or abiotic.

Growth promotors act as culture-friendly elicitors. HiMedia offers promotors like Indole butyric acid and 6-Benzylaminopurine, if used with suitable combinations, can highly affect the root, shoot and callus induction in plants respectively.

Apart from callus, hairy root cultures treated with Agrobacterium rhizogenes act as potential reservoirs for production of desirable compounds. Alterations in chemical elicitors in media can be a cost effective technique. Studies show that a lower ratio of ammonium nitrogen in Ginseng is more conducive to the synthesis of Ginsenosides and polysaccharides.

Few other categories of hormones have also been recognised for their role in inducing stimulatory responses. Plants have been used for medical purposes since ancient times and HiMedia’s Jasmonic acid and Salicylic acid can act as efficient elicitors in the production of commercially valuable bioactive compounds like Withaferin A, Dopamine, Gingsenoside, etc., from most of the medicinal plants. With such advancement in science and technology, plant tissue culture being a novel approach can be a leap towards commercializing valuable bioactive compounds.

Siddharth PoreJr. Plant Biotechnologist Plant Tissue Culture

Role of Elicitors

Elicitor binds to the receptor on the plasma membrane

Produces secondary

metabolites

Elicits gene expression

Activates defensive responses


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Across3. Microscopic single celled prokaryotes.5. A disease outbreak that spreads across

countries or continents.7. Longest part of large intestine which

removes waste products from the body9. The body’s ability to prevent the invasion of

pathogens10. A viral respiratory illness caused by a

coronavirus in the year 2002

Down1. A large protein molecule capable of

inducing an immune response in the body.2. Double helix genetic structure4. An acute disease that is marked by

inflammation of lung tissue.6. An important mineral that builds and

maintain our bone strong8. The building blocks of the nervous system

CROSSIT


MICROBIOLOGY : CHANGING HORIZONS IN MICROBIAL DIAGNOSIS

Diagnosis is nothing less than an art of science and a continuous challenge posed to our scientists

worldwide by the imperceptible microbes.

Automation in culture based techniques:

With the technological advances being observed against the challenges we are facing today, there are a wide variety of diagnostic tests and automation available which have significantly improved the ability for accurate diagnosis.

Moreover, even bacteriology automation has been introduced with barcoded petriplates, automated streaking with robotic loop for reproducible inoculation and streaking pattern, automated incubation where the start and end time is recorded and the plates are then automatically moved to image analyzer for reading.

“Automated lab for Microbiology - Plating and Colony Picking on the Tecan Fluent “ https://youtu.be/fUXLYqFQhtw

“Precise Count - Fully automated colony counting system”

https://youtu.be/p-gdadVOu7U

Other than these culture based techniques which continue to be the linchpin for microbial diagnosis, other diagnostic methods have evolved to molecular and genomic methods including detection of infectious disease indicators and microbial markers.

Biomarkers in molecular diagnostics:

The use of 16S rRNA gene sequences to study bacterial phylogeny and taxonomy has been by far the most commonly used genetic marker for identification and classification of microbes. The clinical validation of biological, physiological, or morphological markers determine which marker or which combination of markers is reliable, relevant and specific to the measurement of predetermined process or the patient response to a therapy. Biomarkers have been used for clinical diagnosis of multiple diseases for many years, for example, troponin level for diagnosing myocardial infarction, creatinine for diagnosing renal insufficiency, and amylase for pancreatitis. Diagnostic biomarkers that identify disease subtypes thus often play critical roles when the results of diagnostic classification can be used as prognostic biomarkers and predictive biomarkers.


PCR and Bioassays:

Several PCR based assays including fluorescence in situ hybridization using peptide nucleic acid probes (PNA FISH) is a diagnostic technique combining the simplicity of traditional staining procedures with the unique performance of PNA probes to provide rapid and accurate diagnosis of infectious diseases. Similarly microarray assays, reverse line blot hybridization assays, multiplex real-time PCR assays, all target a panel of clinically relevant bacterial and fungal pathogens. Another multiplexed bead-based bioassay system, the Quantamatrix Multiplexed Assay Platform system aids in distinguishing gram positive and gram negative bacteria, Candida species and genes for antibiotic resistance including mecA gene of MRSA, vanA and vanB of Vancomycin resistant Enterococci and CTX-M gene of ESBL producing Enterobacteriaceae.

Advances in mass spectrometry (MS)-based disease biomarker discoveries are continuously expanding the clinical diagnostic landscape. All these tools have revolutionized the field of clinical diagnostics. We have indeed come a long way in this diagnostic world of microbes and shall always continue to successfully crack their transitions to tests for infallible diagnosis.

Dr. Santosh Kaul,QA ManagerMicrobiology

Molecular biology based on genomic, transcriptomic, proteomic or metabolomic biomarkers helps to develop precise diagnostics. Mass spectrometry, an analytic chemistry technique which generates multiple ions from the sample under investigation, and then separates them according to their specific mass-to-charge ratio, recording the relative abundance of each ion type is used as a powerful tool for diagnostic microbiology lab. Indeed, it was demonstrated that different bacterial species show specific protein mass spectra, which can be used for rapid identification. In mass spectrometry, an ionization technique that uses a laser energy absorbing matrix to create ions from large molecules (MALDI-TOF) MS is a method to characterize bacteria, mycobacteria and certain fungal pathogens



IMPORTANCE OF Ig BASED DIAGNOSIS FOR COVID-19

As of 20th August, 2021, more than 209 million cases of SARS-CoV-2 have been

confirmed and nearly 4.4 million deaths have been reported by World Health Organization (WHO). At present, RT-PCR and serological antibody are the key tests for Covid-19.

Molecular tests like RT-PCR and antigen tests show active infection. COVID-19 Serology test is used for diagnostic, surveillance or epidemiological purposes which rely on targeted antibodies binding to SARS-CoV-2-specific antigens.

Advantage of serology test

• It allows the identification of individual who have previously been infected, which can be used to guide epidemiology and sero-prevalence studies, as well as facilitate contact tracing.

• It can be used for potential convalescent plasma donors.

• It helps to evaluate the immune response post vaccination (Covishield, COVAXIN, Sputnik V, Moderna and Johnson & Johnson vaccines in India).

• It determines the vaccine efficacy in vaccines research.

• It helps diagnosis of COVID-19 in RT-PCR negative patients who present later during disease course and are asymptomatic.

An antibody, which is also called an immunoglobulin (Ig), is a protective protein produced by the B- cells in response to a foreign substance (antigen) or pathogen.

Largely, IgM, IgG, IgA and total antibody tests are used to understand the immune status of an individual.

Figure showing the serology graph of various Iq for infection/vaccination


Dr. Manjusha Rani (PhD),Principal ScientistAnimal Tissue Culture

Dr. Priyanka Majumder (PhD),Senior Research OfficerAnimal Tissue Culture

• IgM usually develops first after 5-7 days post infection. The IgM rises rapidly and declines quickly, thus indicating an early infection.

• IgG is the most abundant Ig which expresses 7 days post infection, peaks around 14-21 days and remains in the bloodstream for months. Presence of IgG helps in diagnosis of asymptomatic or past infection.

• IgA response comes as early 5 days post infection mainly in serum, mucosal surface, saliva etc.

Commonly used Ig tests and result Interpretation-

I. IgM-positive but IgG-negative (IgM+IgG−)- Active phase of viral infection

II. IgG-positive but IgM-negative (IgG+IgM−)- Atleast 8 weeks past infection

III. Both IgM-positive and IgG-positive (IgM+IgG+)- Can be active infection or recent past infection

The platforms for COVID-19 serology tests are Lateral flow (LAF), CLIA (chemiluminescent immune assay) and ELISA (enzyme-linked immunosorbent assay) tests with 70%, 99% and 99% of sensitivity, respectively. Of all the platforms, ELISA is comparatively cheaper having high sensitivity and specificity.

Looking at the unprecedented pandemic and urgent need of the country, HiMedia has partnered with Syngene International and developed highly accurate and validated ELISA kit (EL001) (brand name ELISafe 19™) for qualitative detection and EL002 (brand name ELISafe Q™) for quantitative detection of IgG against S1 spike protein of SARS-CoV-2 in plasma/serum in just 2.5 hrs.

This kit shows approx. 99% sensitivity and ~100% specificity. ELISafe 19™M kit gives the index value of 0.9< as negative, 0.9-1.1 as equivocal and >1.1 as positive IgG. The index value of the positive serum interpret the immune status as

I. medium low 5.0<

II. medium high 5.0-10.0<

III. high >10.0

Having index value more than 5.0 > post infection suggest that plasma of recovered patient can be used for plasma therapy to tackle the second wave of COVID 19 in India to save life. Most

importantly antibody testing of IgG also allows to monitor enough antibody is developed against SARS CoV 2 post-vaccination.

Recognition of S1 antigen of SARS CoV-2 by immunoglobulins.

MOLECULARBIOLOGY

ANIMAL CELLCULTURE

MICROBIOLOGY PLANT TISSUECULTURE

HYDROPONICSSOILLESS FARMING

LAB AIDS &INSTRUMENTATION

CHEMICALS &BIOCHEMICALS

Range of HiMedia Products

• • • expect only quality from us™

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Ready Prepared Media Provided in the KitCode Product

MP5476 Mucormycosis Selective Agar Plate

MP5477 Candida Selective Agar Plate

MS5478 HiFungal Transport Medium w/swab

MucormycosisFungal Infections in COVID-19 PatientsHiMedia introduces Mucormycosis Detection Kit [K144]

A complete kit for clinicians to collect and isolate the fungiresponsible for Mucormycosis from the patient sample "One-Stop" solution for selective isolation of Mucormycosis fungi within 24-48 hours

HiFungal™ Transport Medium preserves fungal specimen till 72 hours

The unique formulation of MP5476 and MP5477 supports rapid and selective growth

Lockable plates ensure user's safety

The pure fungal strains so obtained can be retained for antimicrobial susceptibility and taxonomic studies

NewIntroduction


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