Lähettäjä: Soijuv Lähetetty: 19.4.2005 8:48
Suomessa muutama jäsenemme saa parhaillaan immunoglobuliinihoitoa. Seuraavassa amerikkalaisen kokemus hoidosta tammikuun alusta 05. Hän saa kolmen viikon välein 50 g immunoglobuliinia iv. Tulokset ovat alkaneet näkyä 3 1/2 kk:n hoidon jälkeen. Hyviä tuloksia on kuulemma odotettavissa noin vuoden sisällä. Hän saa immunoglobuliinin lisäksi antibioottia sillä lääkärin mielestä antibioottien teho on parempi kun sitä käytetään yhdessä immunoglobuliinin kanssa.
"well i have been on IVIG since Jan '05. 50 grams infused over 3 hrs every third week.
my IVIG (IV gammaglobulin therapy) seems is finally starting to work after 3 and half months.
my immunologist said at least that long to see any results, six months for adequate results, a year for good results.
my LLMD feels the IVIG will make the antibiotics much more effective since my immune system will be producing enough antibodies to allow the abx to do their job with greater efficiency.
and feeling i may have a good summer coming. keep you guys updated on how that works out.
probably be on the IVIG for a year.
the previous infusion made me herx like crazy. i couldn't believe it.
it was very weird. must have been killing spirochetes by the induction of antibodies at a replication period.
also rocking a course of pulsed rocephin. only in week 3 of, if effects are good, probably a couple month course.
keep u updated.
cheerio
-zip"
http://flash.lymenet.org/ubb/Forum1/HTML/033344.html
IMMUNOGLOBULIINIHOITO
Valvojat: Jatta1001, Borrelioosiyhdistys, Bb
IMMUNOGLOBULIINIHOITO
Viimeksi muokannut Bb, Su Maalis 08, 2009 20:07. Yhteensä muokattu 1 kertaa.
Lähettäjä: Soijuv Lähetetty: 19.4.2005 8:59
Lisää kokemuksia IG:n käytöstä. Seuraava henkilö on saanut hoidosta paljon hyötyä. Hänellä ei ole enää jatkuvia hengitysteiden infektioita, neuropatiaa, lihasheikkoutta yms:
been on IVIG for over two yrs now, with excellent results
No longer have the serious sino-pulmonary infections, and my perpherial neuropathy seems to be completely under control--at this time.
Nero-muscleur( moderate muscleur weakness on testing) issues seemed to have resolved also--this was the latest and last symptom to resolve.
Few things that I can add to the party here:
I just survived a review per the usage of IVIG by my insurance carrier---since I had already had the EMG, with muscle and nerve biopsy done--we just resubmitted this testing
Why?
Nerve regeneration doesn't happen all that fast--and the previous testing was still considered *current* testing
Foggy, the above information is for your benefit--did they do the biospies when they did the EMG? If so, you should be home free--if your insurance is private
Medicare, and Medicaid have different classifications, and testing protocals--you may have to review those to see where you fit in.
Zip: When you are reviewed, discuss with your immuno--per what your current troughs levels have been, as to how long you would need to be off the IVIG for your levels to drop below normal again.
In some people it can drop as quickly as one month, in some it can take as long as three months'
You may also want to ask about vaccination challenges--if needed for insurance approval
Most major insurance carriers are using AMC mangement--which is an automated management system that was designed by a doctor--so there would not be a need for expensive case managers.
Needless to say, this doc is sitting on the money now.....wish I had thought of it first
The good news--my case slid right though this system--per CVID diagnosis, which if my memory serves me, is also your DX., so most likely you will slide though, too.
With regards to supplements that will boost a truly depressed immune system--one that requires IVIG to maintain it's functionality
Forget it--all the transfer factor in the world, and Mg, and CA are not going to replace IVIG--and I'm a PharmD with 23 yrs experince.
I'm not saying they don't help with other symptoms relating to Lyme--but it's really a moot issue on this topic matter.
But for those of you with a scientific bent, here's an interesting medical abstract with regards to CVID(Common Variable Immune Deficientcy, which generally means low IgG subclasses "AND" one other component, and /or antibody class of the immune system is also malfunctioning)
Low IgG subclasses are just that( hypogammaglobulinemia) and are not CVID
http://cdli.asm.org/cgi/content/full/5/3/399
Adenosine Deaminase Deficientcy and Purine Nucleoside Phosphorylase Deficientcy in Common Variable Immune Deficientcy
Zip, if you get a chance--read this medical model---and see just how you feel/think this relates to Borrelia--because I feel there is something to this with regards to patients like us.
No rush, post back on this in a couple of days, when you get the chance
--------------------------------------------------------------------------
Seuraava henkilö saa IG:tä ainoastaan 5g ja sai siitä hyötyä välittömästi:
Interesting thread. I do IVIG but only about 5 grams, and that is usually over 2-3 hours. Fifty grams would take me forever. I don't have any special neurological or immunological diagnosis but zipzip can you email me (I see your email isn't on here) and let me know who your doc is since I'm also in NYC? I'd like to have my doc run some similar tests or see if my insurance covers your doc.
I found it instantly helpful.
I did have a weird reaction a couple of times. In the beginning I had some low grade fevers but I do not think that was lyme related as that can be common.
About two months ago I had a weird reaction with what I thought was chest pain, and then wheezing, for several weeks. I got extremely worried as thrombotic events can be associated with IVIG, and since hypercoagulation can be a problem in lyme and chronic infection, and since IVIG inevitably increases blood viscosity (you can search pubmed for this)...but all tests were normal and the symptoms abated, and besides, the chest pain apparently was chest wall tenderness. So I wondered if it was some odd kind of kill of something, lyme or whatever, based on the antibodies in that batch.
Last week I tried gamunex which is the purest and I got a rather bad migraine that night.
I drip this stuff extremely slow or I react to it. Generally it gives me more energy and my muscles feel stronger, I walk faster etc. In fact, I've gotten used to doing it for at least six months now so I feel it moved me up another notch or two. I am not doing any drugs of any kind. IVIG, home hyperbaric, some other alternative stuff, and researching even more alternative stuff.
Lisää kokemuksia IG:n käytöstä. Seuraava henkilö on saanut hoidosta paljon hyötyä. Hänellä ei ole enää jatkuvia hengitysteiden infektioita, neuropatiaa, lihasheikkoutta yms:
been on IVIG for over two yrs now, with excellent results
No longer have the serious sino-pulmonary infections, and my perpherial neuropathy seems to be completely under control--at this time.
Nero-muscleur( moderate muscleur weakness on testing) issues seemed to have resolved also--this was the latest and last symptom to resolve.
Few things that I can add to the party here:
I just survived a review per the usage of IVIG by my insurance carrier---since I had already had the EMG, with muscle and nerve biopsy done--we just resubmitted this testing
Why?
Nerve regeneration doesn't happen all that fast--and the previous testing was still considered *current* testing
Foggy, the above information is for your benefit--did they do the biospies when they did the EMG? If so, you should be home free--if your insurance is private
Medicare, and Medicaid have different classifications, and testing protocals--you may have to review those to see where you fit in.
Zip: When you are reviewed, discuss with your immuno--per what your current troughs levels have been, as to how long you would need to be off the IVIG for your levels to drop below normal again.
In some people it can drop as quickly as one month, in some it can take as long as three months'
You may also want to ask about vaccination challenges--if needed for insurance approval
Most major insurance carriers are using AMC mangement--which is an automated management system that was designed by a doctor--so there would not be a need for expensive case managers.
Needless to say, this doc is sitting on the money now.....wish I had thought of it first
The good news--my case slid right though this system--per CVID diagnosis, which if my memory serves me, is also your DX., so most likely you will slide though, too.
With regards to supplements that will boost a truly depressed immune system--one that requires IVIG to maintain it's functionality
Forget it--all the transfer factor in the world, and Mg, and CA are not going to replace IVIG--and I'm a PharmD with 23 yrs experince.
I'm not saying they don't help with other symptoms relating to Lyme--but it's really a moot issue on this topic matter.
But for those of you with a scientific bent, here's an interesting medical abstract with regards to CVID(Common Variable Immune Deficientcy, which generally means low IgG subclasses "AND" one other component, and /or antibody class of the immune system is also malfunctioning)
Low IgG subclasses are just that( hypogammaglobulinemia) and are not CVID
http://cdli.asm.org/cgi/content/full/5/3/399
Adenosine Deaminase Deficientcy and Purine Nucleoside Phosphorylase Deficientcy in Common Variable Immune Deficientcy
Zip, if you get a chance--read this medical model---and see just how you feel/think this relates to Borrelia--because I feel there is something to this with regards to patients like us.
No rush, post back on this in a couple of days, when you get the chance
--------------------------------------------------------------------------
Seuraava henkilö saa IG:tä ainoastaan 5g ja sai siitä hyötyä välittömästi:
Interesting thread. I do IVIG but only about 5 grams, and that is usually over 2-3 hours. Fifty grams would take me forever. I don't have any special neurological or immunological diagnosis but zipzip can you email me (I see your email isn't on here) and let me know who your doc is since I'm also in NYC? I'd like to have my doc run some similar tests or see if my insurance covers your doc.
I found it instantly helpful.
I did have a weird reaction a couple of times. In the beginning I had some low grade fevers but I do not think that was lyme related as that can be common.
About two months ago I had a weird reaction with what I thought was chest pain, and then wheezing, for several weeks. I got extremely worried as thrombotic events can be associated with IVIG, and since hypercoagulation can be a problem in lyme and chronic infection, and since IVIG inevitably increases blood viscosity (you can search pubmed for this)...but all tests were normal and the symptoms abated, and besides, the chest pain apparently was chest wall tenderness. So I wondered if it was some odd kind of kill of something, lyme or whatever, based on the antibodies in that batch.
Last week I tried gamunex which is the purest and I got a rather bad migraine that night.
I drip this stuff extremely slow or I react to it. Generally it gives me more energy and my muscles feel stronger, I walk faster etc. In fact, I've gotten used to doing it for at least six months now so I feel it moved me up another notch or two. I am not doing any drugs of any kind. IVIG, home hyperbaric, some other alternative stuff, and researching even more alternative stuff.
Viimeksi muokannut Bb, Su Maalis 08, 2009 20:08. Yhteensä muokattu 1 kertaa.
Lähettäjä: Soijuv Lähetetty: 21.4.2005 14:09
Lisää kokemuksia immunoglobuliinihoidosta:
V. 1997 90g IG:tä (1 gr/painokilo) 11 kertaa - halvaus parani osittain. IVIG yhdessä antibiootin kanssa on ollut hänelle tehokkain hoito:
"1994-97 my HMO Drs. pooh-poohed my complaints of increasing fatigue. When I developed paresis in June 1997 they said I had Guillain Barre syndrome, and gave me plasmapheresis, then steroids and then 90 gram IVIG treatments. I received eleven doses of the IG Aug 19 1997 - May 10 1999,
90 grams per treatment (one gram IG per kilo body weight).
IG gave me short term, partial relief of the paresis. But I still felt SICK. And I had to get cavitation surgery on my jaws without HMO help too, starting in 1997.
In 1999 a non-HMO Dr. said I had Lyme disease. I asked the HMO for antibiotics, but it suggested that antibiotics were too dangerous. They also said there was no evidence of Lyme or any other infection.
Paying out of pocket once again I began IV antibiotics on May 17, 1999: they enabled me to keep the paresis in check (my HMO Drs have not given me IVIG since May 10, 1999) but when I asked my HMO Dr. to give me both IG and antibiotics he suggested that IG is too dangerous.
IV & later oral antibiotics did me more good than IVIG alone so it seems sensible (if politically incorrect) to boost immune system with IG and bash Bb with Abx.
Oral IG gave me some short term benefit, but nothing like the IV benefit.
-----------------------------------------------------------------------------------
8kk 25g Gamunexia - hoito on auttanut:
I've been on IVIG for 8 months and also am finding it helpful. ...... I get 25 grams of Gamunex four days per month (2 days in a row, every 2 weeks). I get a liter of IV saline prior to each Gamunex treatment. That, along with Solu-Cortef, benadryl and tylenol seem to help make it easier to tolerate.
-----------------------------------------------------------------------------------
25g kerran kuukaudessa joulukuusta lähtien. Osa neurologisista oireista, näkö ja tasapaino ovat tähän mennessä parantuneet huomattavasti:
I 'had' Lyme in '94....I am supposedly a 'cure' as standard testing is negative. Igenex is still positive, but physicians in Wisconsin disregard that.
I receive IVIG as immunomodulation because somewhere down the line, I got small fiber (peripheral) neuropathy. HMMM, wonder where that came from? Anyway, that also hit my autonomic nervous system, which is part of the peripheral nervous system. Small fibers are non or thinly myelinated fibers, as opposed to the myelinated fibers that MS affects. However, the symptoms I have are very similar to MS, except for the autonomic ones, which are untypical in MS. Rheumatologists have dismissed my disease as not autoimmune, however, my neurologist feels I have autoimmune autonomic neuropathy by cellular findings, and neurochemical abnormalities rather than serological markers.
Either way, I think the IVIG is helpful, however, I don't think I receive enough and at $3000 per bag, I am unlikely to get more. I receive the treatment to stop the progression of the autonomic degeneration which has left me very bradycardic (40BPM), globally anhidrotic (vulnerable to overheating) and with labile blood pressures which range from 50/30 to 200/103. There is also the issue of numbness, tingling, pain, ataxia and general cholinergic failure, including sicca symptoms. I also have a movement disorder. It is a battle to get IVIG and it isn't cheap. It is a blood product, and although 'washed' needs to be weighed against the risk. IVIG consists of antibodies from thousands of individuals in each bag! We don't understand much about how disease spreads, and there is risk with IVIG, no doubt. IVIG is clincally approved for only a few conditions at either end of the spectrum of immune boosting for conditions that cause immunosupression or immune modulation in conditions that are autoimmune.
Autoimmune neurological disease has responded favorably to IVIG and has produced nerve regrowth in a few cases. IVIG has proved useful in many sensory neuropathies except for the hereditary type. I have no side effects from IVIG itself, some people do, including transfusion reactions, again it is a blood product. I get 25 grams per month over a 3 hour infusion time. I weigh 136. It is dosed by body weight. I get worse at the end of the month right before my next infusion. I got the attention of a cardiologist when they thought I had a stroke due to numbness and a high BP. Via the cardiologist, bless him, a triathlete himself, I got to a neurologist at a research center. I flunked a tilt table test(blood vessel involvement) and sweat test (skin nerves involved) last summer and after that received skin biopsies in the fall. I was also evaluated by a gastroenterologist with a specialization in autonomic neuropathy due to nausea and other GI problems and a neuro-opthamologist for vision defocusing. After I was confirmed having small fiber neuropathy with autonomic neuropathy deemed autoimmune, they initiated IVIG in December with a loading dose of 25grams every other day x 5. My prognosis: I might not get any worse, but I won't get any better either. As I said in my other post, my vision and balance have improved greatly. Numbness and tingling somewhat better, pain unchanged and significant. Stamina is still poor in my opinion. BP has held steady in the low 100/60's and pulse steady around 50-56 with out beta blockers, or other cardioactive, vasoactive drugs, which were a nightmare for me due to the labile nature of my BP and low pulse. I would not call it a miraculous recovery, but I expect after lyme disease I would have permanent damage. I also expect that this damage will not be attributed to Lyme disease, as my titers on their tests are negative, although I have a clinical diagnosis due to a recorded tick bite, EM and rising titer. It may not be the result of Lyme disease at all, who knows? 18-24 months ago, I pulled off a season of 5Ks and sprint triathlons despite feeling very crappy. It was a mind over matter thing of personal importance. (Not this year, but I am walking and swimming...and I have to begin a resistance training program again, but I have been reticent due to severe total body flare ups when I try...it is an aversion I have to get over at some point.) IVIG is not a cure for chronic lyme disease in my opinion. I am not sure there is a 'chronic lyme disese' or if you are just stuck with a ravaged body which will show up as a number of other conditions which require a number of different management regimens or potshots whatever one wants to call them. However, any one with a history of Lyme might well consider skin biopsies for peripheral (small fiber) neuropathy. You might be surprised by the results, I was. I was utterly shocked that I had neuropathy. I attributed my pain and other symptoms to overtraining, undertraining, some occult arthritis, broken bones (had a few) migraines, herniated discs,menopause, lyme (which may very well be at the bottom of all of it), over zealously prescribed anticholinergic drugs, and last but not least, mental illnes.
I have no idea how long I will be on the IVIG, however, as long as I am reasonable with my requests, tolerate the bad week to 10 days per month, and I don't deteriorate too much, don't beg for pain pills, make a sincere effort to exercise reasonably and pace my work load, eat well (very hard due to nausea, early saiety and post prandial hypotension), I doubt I will raise a red flag. I don't doubt that I will have to do a trial without it in the future to substantiate its efficacy. That is the story of my IVIG. I will glady answer any questions any one has.
Lisää kokemuksia immunoglobuliinihoidosta:
V. 1997 90g IG:tä (1 gr/painokilo) 11 kertaa - halvaus parani osittain. IVIG yhdessä antibiootin kanssa on ollut hänelle tehokkain hoito:
"1994-97 my HMO Drs. pooh-poohed my complaints of increasing fatigue. When I developed paresis in June 1997 they said I had Guillain Barre syndrome, and gave me plasmapheresis, then steroids and then 90 gram IVIG treatments. I received eleven doses of the IG Aug 19 1997 - May 10 1999,
90 grams per treatment (one gram IG per kilo body weight).
IG gave me short term, partial relief of the paresis. But I still felt SICK. And I had to get cavitation surgery on my jaws without HMO help too, starting in 1997.
In 1999 a non-HMO Dr. said I had Lyme disease. I asked the HMO for antibiotics, but it suggested that antibiotics were too dangerous. They also said there was no evidence of Lyme or any other infection.
Paying out of pocket once again I began IV antibiotics on May 17, 1999: they enabled me to keep the paresis in check (my HMO Drs have not given me IVIG since May 10, 1999) but when I asked my HMO Dr. to give me both IG and antibiotics he suggested that IG is too dangerous.
IV & later oral antibiotics did me more good than IVIG alone so it seems sensible (if politically incorrect) to boost immune system with IG and bash Bb with Abx.
Oral IG gave me some short term benefit, but nothing like the IV benefit.
-----------------------------------------------------------------------------------
8kk 25g Gamunexia - hoito on auttanut:
I've been on IVIG for 8 months and also am finding it helpful. ...... I get 25 grams of Gamunex four days per month (2 days in a row, every 2 weeks). I get a liter of IV saline prior to each Gamunex treatment. That, along with Solu-Cortef, benadryl and tylenol seem to help make it easier to tolerate.
-----------------------------------------------------------------------------------
25g kerran kuukaudessa joulukuusta lähtien. Osa neurologisista oireista, näkö ja tasapaino ovat tähän mennessä parantuneet huomattavasti:
I 'had' Lyme in '94....I am supposedly a 'cure' as standard testing is negative. Igenex is still positive, but physicians in Wisconsin disregard that.
I receive IVIG as immunomodulation because somewhere down the line, I got small fiber (peripheral) neuropathy. HMMM, wonder where that came from? Anyway, that also hit my autonomic nervous system, which is part of the peripheral nervous system. Small fibers are non or thinly myelinated fibers, as opposed to the myelinated fibers that MS affects. However, the symptoms I have are very similar to MS, except for the autonomic ones, which are untypical in MS. Rheumatologists have dismissed my disease as not autoimmune, however, my neurologist feels I have autoimmune autonomic neuropathy by cellular findings, and neurochemical abnormalities rather than serological markers.
Either way, I think the IVIG is helpful, however, I don't think I receive enough and at $3000 per bag, I am unlikely to get more. I receive the treatment to stop the progression of the autonomic degeneration which has left me very bradycardic (40BPM), globally anhidrotic (vulnerable to overheating) and with labile blood pressures which range from 50/30 to 200/103. There is also the issue of numbness, tingling, pain, ataxia and general cholinergic failure, including sicca symptoms. I also have a movement disorder. It is a battle to get IVIG and it isn't cheap. It is a blood product, and although 'washed' needs to be weighed against the risk. IVIG consists of antibodies from thousands of individuals in each bag! We don't understand much about how disease spreads, and there is risk with IVIG, no doubt. IVIG is clincally approved for only a few conditions at either end of the spectrum of immune boosting for conditions that cause immunosupression or immune modulation in conditions that are autoimmune.
Autoimmune neurological disease has responded favorably to IVIG and has produced nerve regrowth in a few cases. IVIG has proved useful in many sensory neuropathies except for the hereditary type. I have no side effects from IVIG itself, some people do, including transfusion reactions, again it is a blood product. I get 25 grams per month over a 3 hour infusion time. I weigh 136. It is dosed by body weight. I get worse at the end of the month right before my next infusion. I got the attention of a cardiologist when they thought I had a stroke due to numbness and a high BP. Via the cardiologist, bless him, a triathlete himself, I got to a neurologist at a research center. I flunked a tilt table test(blood vessel involvement) and sweat test (skin nerves involved) last summer and after that received skin biopsies in the fall. I was also evaluated by a gastroenterologist with a specialization in autonomic neuropathy due to nausea and other GI problems and a neuro-opthamologist for vision defocusing. After I was confirmed having small fiber neuropathy with autonomic neuropathy deemed autoimmune, they initiated IVIG in December with a loading dose of 25grams every other day x 5. My prognosis: I might not get any worse, but I won't get any better either. As I said in my other post, my vision and balance have improved greatly. Numbness and tingling somewhat better, pain unchanged and significant. Stamina is still poor in my opinion. BP has held steady in the low 100/60's and pulse steady around 50-56 with out beta blockers, or other cardioactive, vasoactive drugs, which were a nightmare for me due to the labile nature of my BP and low pulse. I would not call it a miraculous recovery, but I expect after lyme disease I would have permanent damage. I also expect that this damage will not be attributed to Lyme disease, as my titers on their tests are negative, although I have a clinical diagnosis due to a recorded tick bite, EM and rising titer. It may not be the result of Lyme disease at all, who knows? 18-24 months ago, I pulled off a season of 5Ks and sprint triathlons despite feeling very crappy. It was a mind over matter thing of personal importance. (Not this year, but I am walking and swimming...and I have to begin a resistance training program again, but I have been reticent due to severe total body flare ups when I try...it is an aversion I have to get over at some point.) IVIG is not a cure for chronic lyme disease in my opinion. I am not sure there is a 'chronic lyme disese' or if you are just stuck with a ravaged body which will show up as a number of other conditions which require a number of different management regimens or potshots whatever one wants to call them. However, any one with a history of Lyme might well consider skin biopsies for peripheral (small fiber) neuropathy. You might be surprised by the results, I was. I was utterly shocked that I had neuropathy. I attributed my pain and other symptoms to overtraining, undertraining, some occult arthritis, broken bones (had a few) migraines, herniated discs,menopause, lyme (which may very well be at the bottom of all of it), over zealously prescribed anticholinergic drugs, and last but not least, mental illnes.
I have no idea how long I will be on the IVIG, however, as long as I am reasonable with my requests, tolerate the bad week to 10 days per month, and I don't deteriorate too much, don't beg for pain pills, make a sincere effort to exercise reasonably and pace my work load, eat well (very hard due to nausea, early saiety and post prandial hypotension), I doubt I will raise a red flag. I don't doubt that I will have to do a trial without it in the future to substantiate its efficacy. That is the story of my IVIG. I will glady answer any questions any one has.
Lähettäjä: Soijuv Lähetetty: 21.4.2005 14:22
TIETOA VENOGAMMASTA:
Venogamma®
SAFE AND WELL
TOLERATED IV IGG
Venogamma is a safe and efficacious intravenously administrated immunoglobulin preparation, developed by the FRC BTS, to be used in treatments for patients with hypogammaglobulinaemia (common variable immunodeficiency) or idiopathic thrombocytopenia. The safety of the product is based on the following factors: selection of donors, laboratory testing of donor blood, elimination of viruses by several virus inactivation steps during the process and judicious use of the product. In addition to the overall safety, Venogamma has proven to be well tolerated by the patients with less side effects than from comparable products.
FROM IDEA TO PRODUCTION
Venogamma process is an example of a development work made by the FRC BTS starting from a laboratory scale and ending up to commercial scale. The process and product have been improved during the years in many steps.
1997 a first fully automatic chromatographic step for the removal of virus inactivation chemicals was set up. Since then ultra filtration and improved process control have been implemented to further improve the yield and quality of the product.
The FRC BTS has continued to develop the process to make Venogamma in liquid formulation. This development work and clinical investigations are made in collaborative arrangement within the EPFA. The process has already been patented in Australia and applications for patents have been submitted in USA and Europe.
CONTROLLED QUALITY
The quality of the product is based on, in addition to the reliable plasma donations and well established process, on pertinent process systems and plant. While the core process creation is the task of FRC BTS experts, Rintekno as an engineering partner has taken care of the engineering and project services disciplines.
Validation is a quality assurance procedure of a pharmaceutical project, meeting the requests for cGMP and GAMP. Today a tight project time schedule and increased demands on validation requirements have made it necessary to apply a prospective validation. In a team with the client experts the URS will be defined, SOP?s developed and qualifications (IQ, OQ) performed already during the progress of the project. This requires a seamless co-operation between the FRC BTS and Rintekno, as well as the fact that each design discipline acknowledges the demands of validation.
GENERAL INFORMATION ABOUT
AUTOMATION AT THE FRC BTS
Automation at the FRC BTS has been first conceptually developed as a team effort between the FRC BTS and Systecon Oy of the Rintekno Group and Rintekno process engineering during the past years. The automation strategy has been selected together with the FRC BTS and the target has been to meet all the challenging expectations from the process and future. This is why all system deliveries have also been designed to be based on modular and parametrized structures which enable easy future enlargements such as the Venogamma process was.
One of the keys to high quality products is the process automation which is built from the deep understanding of the process core. Controlling continuous processes can be very demanding. Controlling of batch processes can be considered sometimes not only demanding, but as art of the controlling technology. Production scheduling, repeatability of controls and tracking of batches are factors which may seem easy when discussed, but very challenging when implemented in practice.
The policy of Systecon in deliveries is to know the system platform to be applied and the processes to be automated thoroughly. This is ideal for the task of the turnkey system integrator of chemical processes in general. We believe that this principle is particularly a benefit to the FRC BTS in the Venogamma project.
VENOGAMMA AUTOMATION
SUPPLIED BY SYSTECON OY
The supply of the Venogamma automation system included very demanding and complex batch control package based on the Batch Standard S88. Venogamma process has multipurpose and multiproduct nature, which always demands flexible recipes. The degree of automation is very high. This means fully automated sequences and recipes such as buffer preparation and scheduling, chromatographic phases, ultrafiltration and incubation. Process is operated partly during the nighttime without any operating personnel at site. This requires fully automated steps.
The Venogamma project was naturally validated based on the latest GAMP standards. Repeatability and traceability functions as well accurate batch and event reporting were also very important key factors for the FRC BTS. Without ABB Sattline?s system platform we would have faced many difficulties in the project.
Since the time schedule for the project was very challenging right from the very start, the factory acceptance testing (FAT) and commissioning phases at site (SAT, IQ, OQ, PQ) were carried out very thoroughly and strictly ? a trademark of Systecon. The experience of Systecon project team was well demonstrated in the very few changes required into the application configuration during the start-up.
H.R. NEVANLINNA MEDAL
AWARDED TO RINTEKNO
The FRC BTS was founded at the beginning of 1948. Dr H.R. Nevanlinna was appointed the first Head of the FRC BTS. He headed the FRC BTS for 40 years. During the celebration of Rintekno?s 30th anniversary, Timo Virkajärvi, Director of Plasma Products Division at the FRC BTS, awarded the H. R. Nevanlinna medal to Olli Gerdt, President of Rintekno.
The medal was established in 1988 as an award for outstanding contribution to the principles and activities of the FRC BTS.
The award to Rintekno is a token of a long, succesful co-operation with the FRC BTS. The co-operation has not been limited to engineering tasks, but has also included the development of other activities, such as mutual training and common know-how, which have also benefited other plasma fractionators around the world.
The medal is also a recognition of the active donations. Rintekno is very proud of the medal and very proud of the opportunity to work together with the FRC BTS ? a company with excellent reputation and sustainable ethical values.
http://www.rintekno.com/easydata/custom ... tter00.pdf
Reino Kalmari Markku Mänki
Vice President Vice President
Rintekno Oy Systecon Oy
TIETOA VENOGAMMASTA:
Venogamma®
SAFE AND WELL
TOLERATED IV IGG
Venogamma is a safe and efficacious intravenously administrated immunoglobulin preparation, developed by the FRC BTS, to be used in treatments for patients with hypogammaglobulinaemia (common variable immunodeficiency) or idiopathic thrombocytopenia. The safety of the product is based on the following factors: selection of donors, laboratory testing of donor blood, elimination of viruses by several virus inactivation steps during the process and judicious use of the product. In addition to the overall safety, Venogamma has proven to be well tolerated by the patients with less side effects than from comparable products.
FROM IDEA TO PRODUCTION
Venogamma process is an example of a development work made by the FRC BTS starting from a laboratory scale and ending up to commercial scale. The process and product have been improved during the years in many steps.
1997 a first fully automatic chromatographic step for the removal of virus inactivation chemicals was set up. Since then ultra filtration and improved process control have been implemented to further improve the yield and quality of the product.
The FRC BTS has continued to develop the process to make Venogamma in liquid formulation. This development work and clinical investigations are made in collaborative arrangement within the EPFA. The process has already been patented in Australia and applications for patents have been submitted in USA and Europe.
CONTROLLED QUALITY
The quality of the product is based on, in addition to the reliable plasma donations and well established process, on pertinent process systems and plant. While the core process creation is the task of FRC BTS experts, Rintekno as an engineering partner has taken care of the engineering and project services disciplines.
Validation is a quality assurance procedure of a pharmaceutical project, meeting the requests for cGMP and GAMP. Today a tight project time schedule and increased demands on validation requirements have made it necessary to apply a prospective validation. In a team with the client experts the URS will be defined, SOP?s developed and qualifications (IQ, OQ) performed already during the progress of the project. This requires a seamless co-operation between the FRC BTS and Rintekno, as well as the fact that each design discipline acknowledges the demands of validation.
GENERAL INFORMATION ABOUT
AUTOMATION AT THE FRC BTS
Automation at the FRC BTS has been first conceptually developed as a team effort between the FRC BTS and Systecon Oy of the Rintekno Group and Rintekno process engineering during the past years. The automation strategy has been selected together with the FRC BTS and the target has been to meet all the challenging expectations from the process and future. This is why all system deliveries have also been designed to be based on modular and parametrized structures which enable easy future enlargements such as the Venogamma process was.
One of the keys to high quality products is the process automation which is built from the deep understanding of the process core. Controlling continuous processes can be very demanding. Controlling of batch processes can be considered sometimes not only demanding, but as art of the controlling technology. Production scheduling, repeatability of controls and tracking of batches are factors which may seem easy when discussed, but very challenging when implemented in practice.
The policy of Systecon in deliveries is to know the system platform to be applied and the processes to be automated thoroughly. This is ideal for the task of the turnkey system integrator of chemical processes in general. We believe that this principle is particularly a benefit to the FRC BTS in the Venogamma project.
VENOGAMMA AUTOMATION
SUPPLIED BY SYSTECON OY
The supply of the Venogamma automation system included very demanding and complex batch control package based on the Batch Standard S88. Venogamma process has multipurpose and multiproduct nature, which always demands flexible recipes. The degree of automation is very high. This means fully automated sequences and recipes such as buffer preparation and scheduling, chromatographic phases, ultrafiltration and incubation. Process is operated partly during the nighttime without any operating personnel at site. This requires fully automated steps.
The Venogamma project was naturally validated based on the latest GAMP standards. Repeatability and traceability functions as well accurate batch and event reporting were also very important key factors for the FRC BTS. Without ABB Sattline?s system platform we would have faced many difficulties in the project.
Since the time schedule for the project was very challenging right from the very start, the factory acceptance testing (FAT) and commissioning phases at site (SAT, IQ, OQ, PQ) were carried out very thoroughly and strictly ? a trademark of Systecon. The experience of Systecon project team was well demonstrated in the very few changes required into the application configuration during the start-up.
H.R. NEVANLINNA MEDAL
AWARDED TO RINTEKNO
The FRC BTS was founded at the beginning of 1948. Dr H.R. Nevanlinna was appointed the first Head of the FRC BTS. He headed the FRC BTS for 40 years. During the celebration of Rintekno?s 30th anniversary, Timo Virkajärvi, Director of Plasma Products Division at the FRC BTS, awarded the H. R. Nevanlinna medal to Olli Gerdt, President of Rintekno.
The medal was established in 1988 as an award for outstanding contribution to the principles and activities of the FRC BTS.
The award to Rintekno is a token of a long, succesful co-operation with the FRC BTS. The co-operation has not been limited to engineering tasks, but has also included the development of other activities, such as mutual training and common know-how, which have also benefited other plasma fractionators around the world.
The medal is also a recognition of the active donations. Rintekno is very proud of the medal and very proud of the opportunity to work together with the FRC BTS ? a company with excellent reputation and sustainable ethical values.
http://www.rintekno.com/easydata/custom ... tter00.pdf
Reino Kalmari Markku Mänki
Vice President Vice President
Rintekno Oy Systecon Oy