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Healthy Life - Grooming Meets Opportunity


Many of my peers, juniors too approximately seniors oft enquire me: on the purposes that each someone ought to hold upward having.  Sometimes people experience purpose-less, oft at that spot are no assignments - so people experience out-of-place or insecure, or at that spot seem to hold upward irrelevant assignments to hold upward executed or at that spot are assignments which demand to hold upward done, but your pump does non belong to it!  So what is the way out?  Well at that spot is an antidote - life is non exactly nigh doing the allotted assignments: life is genuinely something else: it is nigh PREPARATION!  Life is nigh practicing, verily, PREPARATION MEETS OPPORTUNITY.  This is inward fact, the best theme for life.

Just imagine the life of a committed Hindustani music singer: do you lot recollect her life is alone nigh flitting from i music plan to approximately other program?  Do you lot recollect at that spot are no dry out days - when concert opportunities are non there?!

H5N1 vocalist has her major focus on the early on morn riyaz: exercise session.  It is this preparation time, which gets the maximum focus inward her life. The vocalist focuses on the riyaz or exercise session, which is responsible for her concert performances!  So it is preparation-focus, which ought to hold upward every professional's obsession! And too so doing the project alongside aplomb when chance comes by!!

Define your professional person profile

To start a preparation-focused professional person life, commence alongside agreement your professional person profile.  For instance, equally a medical representative - your profile volition wish sure enough competencies: territory cognition (doctor too chemist profiles, ideal coming together timings, production prescribing behaviors, chemist OTC too commutation behaviour, brusk too quick operate routes inward the territory)..., detailing skills, basic production profile knowledge, challenger production too activeness knowledge, too human relationship management cognition (eg., knowing how to communicate, construct rapport, greet people on exceptional occasions similar their birthday, submitting greetings on festive occasions - Eid Mubarak to Muslims at destination of Ramadan menstruum etc).  

If you lot are a trainer or production manager, empathize the production management concepts too grooming aspects. Focus on preparing for the deliverables.  A lecturer is non a lecturer until he tin give proper lectures!  After agreement the profile requirements too parameters, develop your competencies on those lines continuously!!  That is preparation-focused behaviour.

If you lot are regular to the fitness centre or gym, spell going through the exercise too fitness equipment routine, you lot volition realise that at that spot is no destination to the no. too types of exercises you lot tin perform.  It tin become on too on too on, until you lot tin bring it or you lot receive got the fourth dimension too aptitude for it all... same way, at that spot is no destination to the depths of cognition you lot are trying to master copy inward your professional person sphere!  The cognition too activeness current for preparation is bubbling, continuous too endless!  So preparation is also an endless exercise, alongside several milestones inward the journeying for you lot to move on reaching!!  The biggest room inward the the world is the room for improvement!!  And therein lies endless opportunity.

Your professional person profile is non static!

The mobile phone, whatsapp, facebook, social media, email, ebooks, internet, blogs, biotechnology, rDNA technology, MAB (monoclonal antibody) delineate concern ... these were all merely non at that spot inward 1992, when I started my work-life subsequently M Pharma...  Now these software too social media tools are non bad for communicating knowledge, motivating too keeping a tab on things.  We routinely utilisation social media whatsapp for updating marketing get operate alongside each other!!  This creates a ripple upshot too operate dynamism.  Change is the alone constant of life!!  So how tin the professional person profile hold upward static?  Preparation mental attitude is a continuous process.

Today, grooming is non nigh providing knowledge... at that spot is endless information, data, cognition too insights available inward the information superhighway!  The moot betoken is tin you lot wade through it, acquire what you lot want, grasp the essentials, too set it across inward an easily assimilable manner!?  Can nosotros engage trainees alongside the learning too acquire them excited plenty to acquire too apply it/practice it!?  Are at that spot interesting ways, using modern engineering (web-based, mobile-based or social media based methods) to deliver learning experiences?  If yes, equally a trainer, i has to grasp these novel ways!!  The same chalk too blackboard method or reading from an attractive powerpoint is non enough!  So that makes a professional person trainer's life i of continuous preparation!

Today, that is the demand from a trainer!  The challenge for a trainer is to aid learners acquire the necessary cognition units, science sets, too acquire them motivated plenty to utilisation it inward day-to-day working.  It is i matter to grip the visual assistance inward the grooming spot, however, the fact is: at MD clinics' - visual aids are non fifty-fifty opened, if they are, too so the visual assistance page is flashed for a brief 2nd - laid upward holler is mentioned, pointer is non used... pay-off judgement is non emphasised... the existent challenge is getting learners to acquire too apply!

The MAB (monoclonal antibody) market

Take for instance, inward 1992, B lymphocytes were mainly inward HUP (human physiology) subject.  We learnt that B lymphocytes were a type of agranular leucocytes that produced antibodies which aid destroy antigens (foreign bodies) inward the blood stream.

But today!?  B lymphocytes are billion dollar business!!  B lymphocytes are used to create required target antibodies, which receive got therapeutic, diagnostic too academic uses.  IV (intravenous) infusion: Trastuzumab (humanized mouse based whole antibody) is used for handling of HER 2 positive pectus cancer cases. Various other antibodies are marketed chiefly for handling of autoimmune diseases, infections too cancer. Antibodies are no to a greater extent than natural biomolecules produced equally a role of passive or active immunity yesteryear B lymphocytes inward the body!  B lymphocytes are vital economical entities: producers of antibody poly peptide molecules that receive got billlions of dollars inward sales!!

Genentech (now a fellow member of Roche group) invented trastuzumab (an antibody: specifically a monoclonal antibody).  Their laid upward request this whole antibody IV infusion preparation was HERCEPTIN.  In 1998, the sales of this molecule was 30.50 1000000 USD.  In 2008 annual sales had progressed to 1.38 billion USD (1,382 1000000 USD) - this - alone inward United States of America market! In the the world marketplace position (including United States of America market), Herceptin sales was 1.82 billion USD approx. inward 2008.

As per Fierce Pharma (www.fiercepharma.com) Herceptin had estimated worldwide sales inward 2012 of 6.08 billion USD.  The production patent for trastuzumab (Herceptin) expired inward 2014 for Europe, too inward USA, it volition expire inward 2018.  In the same study from Fierce Pharma, nosotros break that Herceptin is ranked no. 8 pharmaceutical production inward the world, yesteryear sales value inward 2012.

Product patent death has opened upward a marketplace position for biosimilar Trastuzumab brands.  The me-too antibody preparations are called biosimilars.  Bangalore based Biocon has launched its me-too biosimilar antibody trastuzumab nether laid upward name: CANMAb.  International generic major Mylan has the laid upward Hertraz: trastuzumab biosimilar.





CDSCO (Central Drugs Standard Control Organization: www.cdsco.nic.in) has issued a pdf document inward their website: GUIDELINES FOR SIMILAR BIOLOGICS: Regulatory Requirements for Marketing Authorization inward India.  This is a real goodness document that provides an insight into the challenging too enigmatic the world of similar biologics too so makes biosimilars or similar biologics a to a greater extent than friendly science.

Production of antibodies from B lymphocytes soundless appears equally a rocket scientific discipline (!).  It is non equally tardily equally purchasing the chemic active ingredient from a API supplier, sourcing the excipients too punching it all into a marketable shape similar a tablet (with the aid of a BMR (Batch Manufacturing Record), which is also a purchasable item today).  The scientific discipline too experience for handling production of antibodies from B lymphocytes is soundless inward the save of a few companies.

Each B lymphocyte tin create alone i type of antibody.  So it tin deed alone on that type of antigen, which has triggered the production of the antibody.  To commercially create antibodies, at that spot are diverse companies across the world: contract antibody suppliers.  They create query flat antibodies too scale it upward for clinical utilisation or other uses equally per GMP guidelines.  Some of these companies:

A-Bio inward Singapore, AbD Serotech, Adar Biotech, Aeres, Affinity Life Sciences, Agri Bio, Alpha Biologics etc.

These companies produce: 1 g to 10 g quantities of the antibody.  Big factories create upto 10 kg of the antibody.

The full general method for commercial antibody production:

a) the antigen poly peptide is isolated too injected into mice (in 2 doses: primer root loading dose too subsequently 10 days the booster dose)
b) Simultaneously neoplasm cancer cells are grown yesteryear tissue culture: these cancer cells are called myeloma cells
c) B lymphocyte WBC cells from the mice (in whom the antigen poly peptide are injected) are extracted from the spleen of the mice
d) The extract is added to the myeloma cells
e) The final result is HYBRIDOMAS (fusion of B lymphocyte cells too myeloma cells) (various chemicals, equipment, techniques are involved inward this fundamental footstep of the antibody production process: polyethylene glycol is a chemic used, viruses are also used...)
f) HAT medium (hypoxanthine - aminopterin - thymine) is used for pick too increment of hybridomas
g) Screening of the hybridomas for ensuring correct antibody is produced
h) Further culturing of the choose hybridomas
i) Growing the selected hybridomas
j) Harvesting the antibodies
k) Humanization techniques are used to laid upward antibodies "human friendly" so that the human immune scheme accepts them.

The higher upward major steps is real simplistic sequence of the MAB commercial production science.  There are many things involved here: fermentors too other equipment, enzymes too other chemicals, humidity too temperature control, techniques too procedures, valuable experience too many other small-scale "trade secrets" that companies concur close too honey to them!

If alone i antibody is desired too so higher upward physical care for is applicable; the selected B lymphocytes too hybridomas volition create alone i type of antibody.

If the antibodies are produced from a unmarried clone of cells: they are called MABs or monoclonal antibodies.

When antibodies are produced from several dissimilar clones (duplicates) of B lymphocytes they are called polyclonal antibodies.

To ensure Republic of Republic of India gains, biosimilar manufacturing too marketing expertise (just equally nosotros receive got it for chemic based pharma formulations), the drive at Govt. too NGO flat ought to hold upward to give hands-on experiences to do diverse parts of the MAB (monoclonal antibody) science.  For eg., growing hybridomas, fusing B lymphocytes alongside myelomas, pick of correct hybridomas, lectures on HAT medium too its uses etc.  When people acquire yesteryear doing, talking, listening too instruction nigh it all, Republic of Republic of India volition hold upward the gainer too nosotros tin laid upward a score inward the the world alongside MAB delineate concern too!

The preparation-mindset

Not exactly individuals, organizations demand to receive got this PREPARATION MEETS OPPORTUNITY mindset. It necessarily agency having a cognition rich immersive internal surroundings inward the company, constant learning engagements inward the theatre too continuous chance spotting strategies for having the correct preparation strategies.

Biocon could motility into MAB business, through this preparation-mindset.  Individuals likewise demand to receive got a preparation-mindset so that opportunities tin hold upward used.

In a the world where the information float has collapsed, insights are shared at the speed of light: preparation for modify is the key.  Preparation-mindset is vital

Training too the preparation mind-set

Training is non exactly nigh creating learning experiences for science too cognition development.  Today, it is nigh creating too actualizing the preparation-mindset.  Making trainees hungry for modify too knowledge, making trainees hungry for preparing for a bigger challenge.  That is nigh preparation through training.

I give thank you lot you for reading this blogpost.  I also dedicate this blogpost to Ms. Le Trang M Pharm (Paris) of Hanoi, Vietnam, discussions alongside whom triggered this 'preparation meets opportunity' concept. Please do scroll downwardly too read all other posts (click on older posts when required), kindly recommend this spider web log to your acquaintances.

Sumber http://pharmaceuticalshealthcare.blogspot.com

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