GMP IN BIOPHARMACEU

TICALSPresented by SATHEESH KUMAR.SSK in Oxford

college of science.Bangalore.(Dedicated to biotech students community.)

Contact: satheeshbiotech786@gmail.com

CERTAIN COMMON TERMINOLOGIESCleanrooms/BSL/HVAC/MSDS/HEPA/OTC/

NCE/IND/NDA/ANDA/PFF/USFDA/EU/ROW/ICH/

CFR/GMP/GLP/GCP/SCADA/BIOSIMILARS/GENERICS/

BIOEQUIVALENCE/BIOBETTER/GRP/CAPA/large molecule/small molecule

TYPES OF MOLECULE Molecules used as active substances can be

divided into two classes – small and large molecules. They differ not only in terms of size, but also in how they are made, how they behave, their mode of action in the body and their suitability for certain drug forms.

Small, chemically manufactured molecules (or SMOLs for short) are the classic active substances and still make up over 90 percent of the drugs on the market today. By contrast, large molecules – also known as biologics – are therapeutic proteins; they are becoming increasingly important.

Example for small molecule: acetylsalicylic acid (ASA)

Example for large molecule: Insulin.

DIFFERENCE BETWEEN SMALL AND LARGE MOLECULES

REGULATORY BODIES. Every country has its own regulatory authority, which is responsible to

enforce the rules and regulations and issue the guidelines to regulate drug development process,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory  agencies and organizations established in respective countries.

World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), World Intellectual Property Organization (WIPO) are some of the international regulatory agencies and organizations which  also play essential role in all aspects of pharmaceutical regulations  related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.

DRUG DEVELOPMENT PROCESS New drugs begin in the laboratory with scientists, including

chemists and pharmacologists, who identify cellular and genetic factors that play a role in specific diseases. They search for chemical and biological substances that target these biological markers and are likely to have drug-like effects. Out of every 5,000 new compounds identified during the discovery process, approximately five are considered safe for testing in human volunteers after preclinical evaluations. After three to six years of further clinical testing in patients, only one of these compounds on average is ultimately approved as a marketed drug for treatment.

Insilico and invitro analysis plays a key role in this stage of drug development.

An NCE is a molecule developed by the innovator company in the early drug discovery stage, which after undergoing clinical trials could translate into a drug that could be a cure for some disease. Synthesis of an NCE is the first step in the process of drug development. Once the synthesis of the NCE has been completed, companies have two options before them. They can either go for clinical trials on their own or license the NCE to another company.

PRE CLINICAL TRAILS

Pharmacodynamics (what the drug does to the body)..Eg:Agonist or Antagonist.

Pharmacokinetics (what the body does to the drug)

ADME studies. Animal testing a.)Institutional Animal Care and Use Co

mmittee (IACUC)

B.) Committee for the purpose of control and supervision on Experimentation on Animals.(CPCSEA)

PATENT FILING AND IND,CDER

CDER is the largest of FDA's six centers, It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs

Some companies submit a investigation of new Drug (IND) to introduce a new drug product into the market.

IRB reviews the IND, CDER's Manual of Policies and Procedures ( MaPPs) are

approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. All MAPPs are available for the public to review for a better understanding of office policies, definitions, staff responsibilities and procedures.

5210.5 Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs.

The Applicant are allowed to file the patent once IND is approved.

IND There are two IND categories: Commercial Research (non-commercial)The IND application must contain information in

three broad areas: Animal Pharmacology and Toxicology Studies Manufacturing Information Clinical Protocols and Investigator Information Once the IND is submitted, the sponsor must

wait 30 calendar days before initiating any clinical trials.

CODE FOR FEDERAL REGISTRY.(CFR) The final regulations published in the

Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the Code Of Federal Regulations (CFR).  The CFR is divided into 50 titles that represent broad areas subject to Federal regulations.  The FDA's portion of the CFR interprets the The Federal Food, Drug, and Cosmetic Act and related statutes.  Section 21 of the CFR contains most regulations pertaining to food and drugs.  The regulations document all actions of all drug sponsors that are required under Federal law.

EXAMPLES FOR 21 CFR REGULATION 21CFR Part 312 Investigational New Drug

Application/ 21CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval) 21CFR Part 316 Orphan Drugs 21CFR Part 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies 21CFR Part 50 Protection of Human Subjects 21CFR Part 56 Institutional Review Boards 21CFR Part 201 Drug Labeling 21CFR Part 54 Financial Disclosure by Clinical Investigators

CLINICAL TRAILS. Phase-1: To evaluate safety. Ranges 20

to 80 peoples Phase -2: Establishing the efficacy of the

drug, usually against a placebo. Testing with a larger group of people (100–300)

Phase-3:Final confirmation of safety and efficacy. Testing with large groups of people (1,000–3,000)

Phase-4( usually happens after PD and marketing)

PROCESS DEVELOPMENT Process development scientists aim to

optimise the performance of manufacturing systems. They are responsible for identifying and developing new processes for product manufacture, as well as putting in place process controls to make sure the products are of a high quality and are manufactured in a reproducible manner.

Product development scientists work with research scientists to develop new ideas and scientific discoveries, which can be used in the manufacture of new products. They also develop and improve existing products.

NDA OR BIOLOGICAL LICENSE The sponsor submitted a New Drug

Application (NDA) with full information on manufacturing specifications, stability and bioavailablility data, method of analysis of each of the dosage forms the sponsor intends to market, packaging and labeling for both physician and consumer, and the results of any additional toxicological studies not already submitted in the Investigational New Drug application.

NDA New drugs, like other new products, are

frequently under patent protection during development.

When the patents or other periods of exclusivity on brand-name drugs expire, manufacturers can apply to the FDA to sell generic versions.

The Abbreviated New Drug Applications (ANDA) Gives the guidance,laws and regulation for generic drug.

DMF(DRUG MASTER FILE) A Drug Master File (DMF) is a submission to the

Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA),

DMF CONTINUES… This guideline does not impose

mandatory requirements (21 CFR 10.90(b)). It does, however, offer guidance on acceptable approaches to meeting regulatory requirements.

Drug Master Files are provided for in 21 CFR 314.420

TYPES OF DRUG MASTER FILES

There are five types of DMF's: Type I Manufacturing Site, Facilities,

Operating Procedures, and Personnel Type II Drug Substance, Drug Substance

Intermediate, and Material Used in Their Preparation, or Drug Product

Type III Packaging Material Type IV Excipient, Colorant, Flavor,

Essence, or Material Used in Their Preparation

Type V FDA Accepted Reference Information

ESTABLISHMENT OF GMP PRODUCTION PLANT. Clean rooms: HVAC BSL Facility. Upstream Equipments Downstream Equipments Utilities( WFI,purified water,bioler for

steam) Documentation as per GMP regulation

including system enteries. Trained man powers.

VALIDATIONS Some vital examples of validation: Validation of clean rooms Validation of HVAC Validation of process Validation of cleaned container. Validation of equipments installed.

PROCESS VALIDATION. Design qualification: Installation qualification: Operational qualification: Performance qualification

DESIGN QUALIFICATION(DQ) Design Qualification is used at the stage

where a design that has been developed from the, URS and other Health and Safety Guidelines, is reviewed and documented by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements

DESIGN CHART-P&ID(PIPING AND INSTRUMENTATION DIAGRAM)

INSTALLATION QUALIFICATION(IQ) The Installation Qualification (IQ) execution;

verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications. It further details a list of all the cGMP requirements that are applicable to this particular installation qualification. These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the Operational Qualification (OQ).

OPERATIONAL QUALIFICATION(OQ) The Operational Qualification Protocol is

a collection of test cases used to verify the proper functioning of a system. The operational qualification test requirements are defined in the Functional Requirements Specification. Operational Qualification is usually performed before the system is released for use.

PERFORMANCE QUALIFICATION Performance Qualifications are a collection of test

cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification tests requirements defined in the User Requirements Specification (or possibly the Functional Requirements Specification).

Performance Qualifications should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.

FACTORY ACCEPTANCE TEST(FAT) The Factory Acceptance Test (FAT) is a major

project milestone where the vendor demonstrates that the system design and manufacturing meets the contract specifications.

FATs generally consist of the following: Review of the specification line by line while

checking the equipment for compliance with the specification.

Review of appropriate standards and regulations referenced.

Inspection for workmanship. Inspection for damage that can occur during

installation (lift points, accessibility, etc.).

SAT (SITE ACCEPTABLE TEST) A SAT is a Site Acceptance Test the

system is tested in accordance to client approved test plans and specifications to show the system is installed properly and interfaces with other systems and peripherals in its working environment.

CLEAN ROOMS A cleanroom or clean room is an

environment, typically used in manufacturing or scientific research, with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.

CLEAN ROOMS AND ITS CLASSIFICATION

CLEAN ROOM-CLASSIFICATION(USFDA-GMP)

CLASS A CLASS 100 CLASS B CLASS 1000 CLASS C CLASS 10000 CLASS D CLASS 100000

CLEAN ROOMS ISO-CLASSIFICATION

HVAC HVAC (heating, ventilating, and air

conditioning) is the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality.

Ventilation includes both the exchange of air to the outside as well as circulation of air within the building. It is one of the most important factors for maintaining acceptable indoor air quality in buildings.

HVAC AND AHU

HVAC

BIOSAFETY CABINET(BSL) Biological Safety Cabinets (BSCs), which are the

primary means of containment developed for working safely with infectious microorganisms.

Three kinds of biological safety cabinets, designated as Class I, II(type A1,A2 and Type B1 and B2) and class III.

BSL types Personnel protection

Environment Protection

Product Production

CLASS-1 Yes Yes NO

CLASS-2 Yes Yes Yes

CLASS-3 yes yes yes

BSL-1 It is similar in terms of air movement to a

chemical fume hood,but has a HEPA filter in the exhaust system.

unfiltered room air is drawn in through the work opening and across the work surface.

minimum velocity of 75 linear feet per minute (lfm) is maintained through the front opening.

Used in centrifuges, harvesting equipment or small fermenters.

BSL-1

BSL-2 Air flow is drawn from the room around

the operator into the front grille of the cabinet, which provides personnel protection. In addition, the downward laminar flow of HEPA-filtered air provides protection for experimental material inside the cabinet. Because cabinet air has passed through the exhaust HEPA filter, it is contaminant-free, providing environmental protection, and may be recirculated back into the laboratory (Class II Type A) or ducted out of the building (Class II Type B).

BSL2 CONTINUES… Due to the relative size of these two

filters, approximately 30% of the air passes through the exhaust HEPA filter and 70% recirculates through the supply HEPA filter back into the work zone of the cabinet.

BSL-3 The Class III biological safety cabinet is

most suitable for work with biohazardous agents requiring high contain (biosafety level 3 or 4). The Class III cabinet is  completely enclosed, HEPA filter-ventilated cabinet fitted with glove ports and decontamination capabilities for entry and exit of material.  It offers the highest degree of personnel and environmental protection from infectious aerosols. 

BSL-3

COMMON UTILITIES USED PURE STEAM: IMPURE STEAM WFI ( Water for injection): Its helps to

prevent endotoxin contamination Purified water by MCDS Sterile air.

HOW DOES AN BIOPHARMA ORGANISATION FUNCTIONS? Departments.1.) Board of Directors.2.)Human resource and admins3.)Research and development:--- a.)Research investigators b.)Process development4.) Production development5.)Quality assurance6) Quality control7) Storage and packing department.9)Logistics and marketting people.10) Technology transfer department11)IP and IT deparrtments

IMPORTANCE OF QUALITY ASSURANCE IN BIOLOGICS AND BIOPHARMACEUTICALS In the eyes of regulatory authorities, the quality issues of

biologics are definitely different from chemical drugs because of: (1) use of living source materials to produce the biologic, (2) increased complexity of biologic manufacturing processes and (3) increased complexity of the biologic molecules themselves.  While chemical drugs can become generics, biologics products are best viewed as biosimilars, and not as bio-generics.

Biologics are highly susceptible to adventitious agent contamination – prions, viruses, mycoplasmas, and bacteria/fungi microbes. Risk control procedures – such as barriers to entry, testing to confirm absence, and inactivation/removal – are essential. Lessons can be learned from reported contaminations of biologic manufacturing processes. Compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities

QUALITY ASSURANCE quality assurance is any systematic

process of checking to see whether a product or service being developed is meeting specified requirements. Many companies have a separate department devoted to quality assurance. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others.

ROLES OF QA1.) Wet lab work: Working along with the team of quality

analyst and manufacturers to ensure Quality,safety and efficacy of a product through out the production process and to ensure the whole process is carried out in compliance with the standard regulatory requirements

ROLES OF QA2) Regulatory work a.)Work with local and international

organisation to guarantee products adhere to certain standards

b.) Prepare submission to regulatory bodies and review submission results

c.) Resolve problems where results fail to meet certain guidelines

d.) One can work either in a pharmaceutical company, for an independent regulatory firm that helps companies, or even for the regulatory bodies themselves.

AUDITING WORK. Pharmaceutical companies routinely

require external audits to ensure operations are in accordance with established guidelines

Audit Types in Biopharmaceuticals: Internal audit A financial audit A compliance audit An operational audit,

INTERNAL AUDIT 1) internal audit with accordance to ICH-

Q10(Quality management system)a.) Plan the auditb.)Conduct the auditc.)Report and close the auditd.)Follow up the audit.

COMPLIANCE AUDIT. Compliance audit will assess level of

conformance with operating procedures as stipulated by contractual arrangements and/or government regulatory agencies, including an investigation of hard-copy prescriptions, computerized records of refills and invoice records.

AN OPERATIONAL AUDIT. An operational audit, also called a

performance or management audit, seeks to evaluate the company's overall efficiency as a vendor administering prescription plans for various sponsors.

A real time Example: GSK, a pioneer in pharmaceuticals is presently dependent on Kemwell biopharma(an CRO) for their production of a X synthetic drug. So GSK holds the right to conduct a performance audit in kemwell to meet the quality standards of production

NON COMPLIANCE 483. An example: The srikulam facility of Dr

reddys lab was inspected by USFDA On nov.14th resulting in a form 483 with nine observations.The observation was largely related to Procedural and other compliances of the plant system.

then later company responded to the agency with its remediation plans and avoided further enforcement.

IMPLEMENTATION OF PRODUCTION Production: can be subdivided under

two streams namely: USP and DSP. The equipments and operations involved differs from product to another product.

QA should be in full swing to prepare BMR,checklist,SOP,EOP,STP. Etc..

QC should be well organised with sophisticated intruments like HPLC,GC,ASS MS. Etc..the instrument requirement differs according to the nature of the product

QUALITY CONTROL QC laboratories controlling the quality of

commercial drugs that are sampled from large repetitive batch production should comply withall GMP requirements listed in CFR Part 210 and 211

There involved three section of Qc analysis in any production plant.

1) Raw material analysis. 2)in process analysis3) Finished product anaysis If any deviation or ooz is observed in the above

said three analysis then it should be informed to QA where they ll try to do CAPA ( corrective and preventive action).

QUALITY CONTROL STABILITY ANALYSIS Quality control Stability analysis falls

into 2 catagories: A) Real time stability analysis B) Facilititated stability analysis.

MARKETTING MARKETTING is the prime and foremost

focus of any owner. Marketing is said to be a heart of any

business. Product selling and technology transfer

are the two rhythms of any biopharmaceuticals

Technology transfer managers who are expert in both technical aswell as management are a key players.

POST MARKETING SURVELLIANCE –OR PHASE 4 OF CLINICAL STUDIES Postmarketing drug surveillance refers to

the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with a drug. The majority of postmarketing surveillance concern adverse drug reactions (ADRs) monitoring and evaluation

PATENT EXTENSION LIMITS united States Patent and Trademark Office (USPT0) is the

regulatory authority for patent management. Once the patent term ends, the innovating company loses

its market exclusivity privilege as generic manufactures enter the market. There however are processes to extend the life of a patent term through “patent term restoration.” Additionally, the innovating company still enjoys market exclusivity while generic manufactures undergo their required FDA approval process.

Another method of patent extension, due to the FDA approval process, is under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Watchman Act. The act provides a maximum 5-year extension, and is limited to a 14-year term from the time of FDA approval. The calculation of extension is complex and depends on patent prosecution and approval factors.

BIOSIMILARS Biosimilars, also known as follow-on biologics, are

biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods.

Biosimilars (or follow-on biologics) are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product.[1] Biosimilars are also referred to as subsequent entry biologics (SEBs)

BPCI ActThe Biologics Price Competition and Innovation Act of 2009Code of Federal Regulations, Title 21, Part 610.10 ... Part

210, 211(21 CFR 210, 211)

BIOBETTER. The term biobetter refers to a recombinant

protein drug that is in the same class as an existing biopharmaceutical but is not identical; it is improved over the original. Biobetters build on the success of existing, approved biologics but are considered less of a commercial risk than developing a brand new class of biologic.

One example is Centocor/J&J’s new anti-TNF (tumor necrosis factor); the first was highly immunogenic — their biobetter is humanized to reduce this undesirable effect.

WHAT ARE BIOBETTERS? HOW DO THEY DIFFER FROM BIOSIMILARS/FOLLOW-ON BIOLOGICS? Biosimilars are seen in some non-U.S. countries as

a “biologic generic.” They are intended to be identical to the originator biologic drugs. But, since they are manufactured using a new process, they will have subtly different structures and possibly different actions. For these reasons, the United States is unlikely to allow them as substitutes for originator biologics without proof from expensive clinical trials. In contrast, biobetters are not copies and will never be considered generics. Biobetters are new molecular entities that are related to existing biologics by target or action, but they are deliberately altered to improve disposition, safety, efficacy, or manufacturing attributes.

BIOBETTERS biobetters may be targeted to have

improved pharmacodynamics leading to less frequent dosing or reduced side-effect profiles or may have sustained or slow release formulations.

WHY ARE COMPANIES PLACING A LARGER FOCUS ON BIOBETTER PRODUCTION? Biobetters allow companies to target an

established mechanism, safety, and efficacy profile but gain the benefit of the patent protection and sales of a new molecular entity. The development costs are the same as developing a new biological product, but the chances of successful registration are significantly higher. This means the business risk in developing a biobetter is significantly reduced and the potential for return on investment for a manufacturer is greatly improved.

SOME VITAL REGULATORY AGENCIES 1.USFDA:The mission of FDA's Center for Drug

Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective

CDER is the largest of FDA's six centers.   It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs

ASME –BPE. ICH FFDCA(Federal Food, Drug, and Cosmetic Act)

regulatory section deals with medical device CMS –CENTRE FOR MEDICARE AND MEDICAID

SERVICES-havecontrols over genetic test and diagnostic kids manufacturing.

CODE FOR FEDERAL REGISTRY The Code of Federal Regulations (CFR) is a

codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year and is usually available here several months later.

Example : 21 CFR part 11 : contains the details about electronic records and signatures

EUROPEAN MEDICAL AGENCY OR EU EU provides information for

companies and individuals involved in developing and marketing medicines for human use in the European Union (EU). 

ICH The International Conference on Harmonisation of

Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

ICH GUIDELINES CLASSIFICATION quality guidelines.(ICH Q1 to ICH Q12) Safety guidelines.(ICH S1 to ICH S11) Efficacy guidelines.(ICH E1 to ICH E18) Multidisciplinary quidelines.( ICH M1 to

M8)

FEW IMPORTANT ICH GUIDELINES CHAPTERS ICH Q7 – GMP ICH Q2 – Analaytical validation ICH Q10- Pharmaceutical quality

system. ICH S2-GENOTOXICITY STUDIES ICH S4-TOXICITY STUDIES ICH E6-Good clinical practice ICH E16- Qualification of genomic

markers.

GLP(FDA HAS RULES FOR GLP IN 21CFR

58) Good Laboratory Practice (GLP) embodies a set of

principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.... GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

GOOD AUTOMATED MANUFACTURING PRACTICE (GAMP) Good Automated Manufacturing

Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry

The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality.

GAMPOne of the core principles of GAMP is that

quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.

HMI(HUMAN MACHINE INTERFACE)

FEDERAL REGULATION OF GENETIC TESTS

Define Biotech industry????: “we are into the business of saving life….Mr. SS.Easwaran-

(Former GM of biozeen).

ACKNOWLEDGEMENT Biozeen Biocon Lablink biotech Mr.Easwaran Dr. Prasad rao. To my father: KR.Sasidharan M/s.sultana. Thankyou one and all of you.you people played a

core role in my life. And will remain a long lasting memory in my heart..i hope this slide will help upcoming biotech students to learn and know about certain basics in biopharmaceuticals(obsolutely not all concepts)..All the best students.

THANKyou.