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Biopharma LLC

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Biopharma LLC
Company typePrivate
IndustryPharmaceutical
Founded1896 in Kyiv
Headquarters
Kyiv
,
Ukraine
Area served
Worldwide
Key people
Efymenko Kostyantyn
Productsmedication
Number of employees
500
Websitewww.biopharma.com.ua/en/home-page/

Biopharma LLC (Ukrainian: ТОВ «Біофарма плазма») is the Ukrainian pharmaceutical company focused on the development and production of drugs based on human plasma.

History

Foundation and early history

In 1895, the Association for the Control of Infectious Diseases was created, and in 1896 the Bacteriological Institute was founded in Kyiv. In 1897, a shelter for vaccination of the population was opened opposite the building.[1]

20th century

In 1920, with the opening of epidemiological, microbiological, parasitological and sanitary-hygienic departments, it was renamed to the "Sanitary and Bacteriological Institute."

In 1938, the Institute was divided into two parts: scientific and manufacturing. It was renamed to the "Ukrainian Institute of Epidemiology and Microbiology." At this time, the staff consisted of 250 employees.[2]

During World War II, the Institute was evacuated to Kuibyshev[disambiguation needed] and continued the research.

After the war, manufacturing returned to Kyiv. In 1955, the manufacturing expanded to 12 bacterial drugs. The institute begins to export to Europe, the Middle East, and India.[3]

21st century

In 2005, the company implemented the technology of the virus inactivation by the solvent/detergent method in the production of immunoglobulins.[4]

In 2005, at the International Forum of Quality, the enterprise received the ISO 9001 certificate.[5]

In 2009, after a series of changes, reorganizations, and renamings (in 1965, 1978, 1992), PrJSC Biopharma was formed.[6]

In 2012, Horizon Capital and FMO invested in Biopharma for building a new biopharmaceutical production factory equipped with a quality control laboratory.[7]

In 2014, the first phase of the Biopharmaceutical Research and Manufacturing Complex was launched in Bila Tserkva. It includes a pharmaceutical plant for the production of medicines, center for research, development and technology, laboratory building for quality control of drugs, warehouses for raw materials and finished products, housing for power systems.[8]

The official opening of the Biopharmaceutical NSC "Biopharma" took place on June 16, 2015.[9] On this occasion, the company handed over medicines worth 1 million UAH, for the needs of the Ministry of Defense and the treatment of military personnel.[10]

In September 2018 company joined The European Business Association (EBA).[11]

2019 (September 19–20) Biopharma jointly with the Ministry of Health of Ukraine held an international forum on blood components and preparations - "Actual issues of industrial production of blood products". Within the framework of the forum, the official opening ceremony of the plasma fractionation plant was held, which became the first such plant in Ukraine and can process up to one million liters of plasma per year.

In September 2019, the official opening ceremony of the plasma fractionation plant took place, which became the first such plant in Ukraine that can process up to one million liters of plasma per year. [12] On this occasion, Biopharma together with the Ministry of Healthcare of Ukraine held an international forum on blood components and preparations - "Current issues of industrial production of blood products". [13] [14] The event was attended by more than 600 professionals from Germany, France, the Netherlands, the United States and other countries. In particular, the forum brought together international experts in the field of clinical and industrial transfusiology. [15]

In December 2019, Biopharma sold part of the company to the German pharmaceutical manufacturer STADA.[16] This decision was made in view of the fact that STADA will be able to bring investment and new expertise in the production and promotion of medicines. Biopharma's shareholders maintained the production of donor plasma drugs and focused on its development both in Ukraine and abroad.

Currently, the company is focused on combating the COVID-19 pandemic and is working in two main areas:

- Clinical trials of one of the main classic products - the drug Bioven, which is used in the complex treatment of complex bacterial and viral pneumonias. Potentially, it can also be used for pneumonia caused by COVID-19.

- The second direction is the development of hyperimmune immunoglobulin from the plasma of those who became ill with coronavirus. Scientists from different countries are inclined to believe that this drug can potentially be effective for the targeted treatment of patients with COVID-19. To do this, Biopharma joined the CoVIg-19 Plasma Alliance [17] [18], which includes 10 world leaders in the production of plasma preparations.

Construction of a new complex

At the end of 2016, Biopharma started the third stage of the construction – the plant for blood plasma fractionation. In October 2017, after the construction of a new building, the installation of technical equipment was started. At the new facilities, the company will produce Albumin, Bioven, and Immunoglobulin that help treat diseases caused by immunodeficiency.[19][20][21][22]

The opening of the new complex took place in summer 2018. Mr. Khmelnytsky and his partners invested $42 million in the research and production facility.[23]

2019 — opening and launch of the first plasma fractionation plant in Ukraine. This technology enables to extract life-saving drugs, requires advanced research and development, GMP-certified equipment and facilities.[24] $75 million was raised to build the plant.[25]

Priorities and social benchmarks

Biopharma is involved in solving the problem of hemophilia and combating the AIDS epidemic and hepatitis C in Ukraine.

In 2017, as part of a public-private partnership, Biopharma invested over $3.5 million in the reconstruction and modernization of the Sumy Regional Blood Service Center.[26][27][28][29] It is the first blood center in Ukraine certified according to the international standard ISO 9001: 2015.[30]

In 2017, Biopharma launched an all-Ukrainian social program “We do care. We are together", aimed at improving the quality of life of patients with hemophilia in Ukraine[31]. In the same year, the company provided charitable assistance to medical institutions of Kyiv region in the amount of UAH 1 million. The company also intends to build 10 modern donor plasma collection centers throughout Ukraine[32] [33].

In March 2018, Biopharma initiated public discussions and held a series of meetings with representatives of the All-Ukrainian Hemophilia Society, the World Hemophilia Federation, and the Children with Hemophilia Charitable Foundation.[34] As a result, a Memorandum of Cooperation was concluded and signed, which makes it possible to implement a system of public control over the production of the drug for patients with hemophilia "BioClot A" [35]. Work continues in this direction, in particular, within the framework of the signed contract, the company sent drugs for control to Germany.[36]

In May 2020, the company decided to change the standards of donor testing. Therefore, all donors are tested for the presence of HIV, hepatitis B and C by NAT, as well as the presence of antibodies to COVID-19 by ELISA on high-precision Swiss test systems ROCHE.

Biopharma is actively developing the culture of donation in Ukraine. The company attracts stars and the public, in particular, the famous Ukrainian singer who supports the culture of donation - Oleh Vynnyk[37]. Biopharma also cooperates with donor organizations such as DonorUA [38] and NOVA KROV[39]. Thus, on the basis of the company's center in the city of Sumy, a record of Ukraine was registered[40]: the largest number of blood donations per thousand population was recorded there. On average in Ukraine, the rate of donations per thousand population is about 14, and in Sumy this figure is 190. This is almost twice as much as, for example, in the United States.

At the end of July 2020, the first Biopharma Plasma center was opened in Cherkasy. The company leased the obsolete regional blood center and turned it into a high-tech progressive European institution. They installed modern equipment and created the most comfortable conditions for both donors and employees.[41][42][43]

The company's activities during the COVID-19 pandemic

In March 2020, in cooperation with pharmaceutical companies from other countries, Biopharma will begin the development of drugs based on the blood plasma of people who have relapsed into COVID-19.[44][45]

At the end of March 2020, Biopharma helped the laboratory of the Center for Public Health of Ukraine of the Ministry of Healthcare to establish a national reference laboratory for the detection of coronavirus. The equipment purchased by Biopharma will allow quickly and according to modern methods to determine the presence or absence of coronavirus pathogens in the obtained samples.[46][47][48] In March 2020, the laboratory has already analyzed hundreds of samples and thus became a flagship in the fight against the spread of coronavirus in Ukraine.[49]

In April 2020, Biopharma was the first in Ukraine to start collecting plasma from people who had recovered from COVID-19. Free tests for the presence of antibodies to coronavirus are conducted for all donors, not just those who have been cured of this disease. Plasma is collected from donors by hardware plasmapheresis. In Ukraine, this technology is used on a regular basis only in Biopharma plasma centers. [50][51][52][53][54][55]

Biopharma has joined the CoVIg-19 Plasma Alliance.[17][18] The purpose of its activity is to develop drugs for COVID-19. World leaders in the production of plasma drugs have joined forces to accelerate the development and production of hyperimmune immunoglobulin. The purpose of the drug is to treat patients with complicated COVID-19. The joint action was initiated by CSL Behring (USA) and Takeda Pharmaceutical Company (Japan). They have already been joined by Biotest (Germany), Bio Products Laboratory (UK), LFB (France) and Octapharma (Switzerland). Biopharma is the only Ukrainian company that is a member of this International Alliance.[17][18][56][57][58] At the end of July 2020, a round table was held in the United States with the participation of the US President Donald Trump. During the event, members of the International CoVIg-19 Alliance reported on the pace of drug development, and the US President called on the public to donate "covid" plasma.[59]

In May 2020, Biopharma received official permission to conduct clinical trials of the classic drug Bioven, which is potentially effective in the treatment of COVID-19.[60] Already in August, the influential American web resource ClinicalTrials.gov published clinical trials of the drug Bioven.[61] During the research, Ukrainian and international experts noted that Bioven reduces the severity of the cytokine storm and stabilizes the condition of critically ill patients. In all who took Bioven, there was a stabilization of the general condition within 2 days after administration of the drug with a subsequent reduction in the manifestations of respiratory failure.[62]

Biopharma intends to invest $ 7 million in the construction of a new office and laboratory complex in Bila Tserkva. There are input and output control laboratories, R&D laboratory, and coworking laboratory. The company plans to provide it to various applicants to work on research projects. Design has already begun, and construction is scheduled to begin in the fall of 2020. [63]

In June 2020, more than 12,000 people have been tested with high-precision Roche systems in Biopharma plasma centers. Antibodies to COVID-19 were detected in 58 Ukrainians. The rate is 0.46% of the total number of donors analyzed.[64]

References

  1. ^ "ВАТ "Біофарма": вікові традиції та сучасна якість | Еженедельник АПТЕКА". Retrieved 2019-08-31.
  2. ^ "History". www.imv.kiev.ua. Retrieved 2019-08-31.
  3. ^ Rimmington, Anthony (2018-11-15). Stalin's Secret Weapon: The Origins of Soviet Biological Warfare. Oxford University Press. ISBN 9780190928858.
  4. ^ "CONSILIUM MEDICUM UKRAINA. №1 2014". www.consilium-medicum.com.ua. Retrieved 2019-08-31.
  5. ^ "Company". biopharma. Retrieved 2019-08-31.
  6. ^ "UNIT.CITY, BIOPHARMA AND OTHER COMPANIES ENTER EBA". Ukraine open for business. 2018-10-07. Retrieved 2019-08-31.
  7. ^ ""Biopharma" is building the scientific and production complex in the value of $70 mln". inventure.com.ua. Retrieved 2019-08-31.
  8. ^ "biopharma". Ufuture. Retrieved 2019-08-31.
  9. ^ "The grand opening of the BIOFARMA innovative biopharmaceutical research and production facility". Ufuture. 2015-06-16. Retrieved 2019-09-03.
  10. ^ ""Біофарма" передала медикаменти для лікування учасників АТО на 1 млн грн". РБК-Украина (in Russian). Retrieved 2019-08-31.
  11. ^ "UNIT.CITY, BIOPHARMA AND OTHER COMPANIES ENTER EBA". Ukraine open for business. 2018-10-07. Retrieved 2019-08-31.
  12. ^ "Біла Церква. Завод «Трібо»: від мрії до успіху - YouTube". www.youtube.com. Retrieved 2020-08-31.
  13. ^ "CoVIg-19 PLASMA ALLIANCE". www.covig-19plasmaalliance.org. Retrieved 2020-08-31.
  14. ^ "CoVIg-19 PLASMA ALLIANCE BUILDS STRONG MOMENTUM THROUGH EXPANDED MEMBERSHIP AND CLINICAL TRIAL COLLABORATION". www.takeda.com. Retrieved 2020-08-31.
  15. ^ "У Києві відбувся міжнародний форум з питань компонентів та препаратів крові". www.ukrinform.ua (in Ukrainian). Retrieved 2020-08-31.
  16. ^ "STADA Arzneimittel AG - Your Partner in Health". STADA. Retrieved 2020-08-31.
  17. ^ a b c "CoVIg-19 PLASMA ALLIANCE". www.covig-19plasmaalliance.org. Retrieved 2020-08-31.
  18. ^ a b c "CoVIg-19 PLASMA ALLIANCE BUILDS STRONG MOMENTUM THROUGH EXPANDED MEMBERSHIP AND CLINICAL TRIAL COLLABORATION". www.takeda.com. Retrieved 2020-08-31.
  19. ^ "Нам не байдуже: проблема гемофілії в Україні та перспективи її вирішення | Компью́терная томогра́фия". www.kievoncology.com. Archived from the original on 2019-08-31. Retrieved 2019-08-31.
  20. ^ "Как развивается единственный в СНГ производитель препаратов крови — интервью с президентом "Биофарма"". delo.ua (in Russian). Retrieved 2019-08-31.
  21. ^ Цензор.НЕТ. "В Белой Церкви открыли новейший биофармацевтический завод". Цензор.НЕТ (in Russian). Retrieved 2019-08-31.
  22. ^ ""Біофарма" передала медикаменти для лікування учасників АТО на 1 млн грн". РБК-Украина (in Russian). Retrieved 2019-08-31.
  23. ^ "Vasyl Khmelnytsky and partners invest $42 mln in Biopharma blood processing plant". 112.international. Retrieved 2019-08-31.
  24. ^ "Biznews – The Ukrainian Journal of Business Law". www.ujbl.info. Retrieved 2019-10-31.
  25. ^ "BIOPHARMA LAUNCHES STATE-OF-THE-ART $75 MILLION PLASMA FRACTIONATION PLANT IN UKRAINE". Ukraine open for business. 2019-09-20. Retrieved 2019-10-31.
  26. ^ SumyNews. "Сумський центр крові – приклад для всієї України — SumyNews". sumynews.com (in Ukrainian). Retrieved 2019-08-31.
  27. ^ ВЕРТІЛЬ, Олександр (2017-03-17). "Щоб імуноглобуліну було вдосталь". Урядовий Кур’єр. Retrieved 2019-08-31.
  28. ^ "Сумський обласний центр служби крові відвідала Голова Держлікслужби : Держлікслужба". dls.gov.ua. Retrieved 2019-08-31.
  29. ^ ""Биофарма" требует разобраться с непрозрачной закупкой лекарств, проведенной ПРООН". www.unian.net (in Russian). Retrieved 2019-08-31.
  30. ^ "Дарувати шанс на одужання". www.golos.com.ua (in Ukrainian). Retrieved 2019-08-31.
  31. ^ "Білоцерківський завод "Біофарма" є єдиним виробником ліків від гемофілії в Україні | Моя Київщина". web.archive.org. 2017-12-28. Retrieved 2020-08-31.
  32. ^ bc-news. ""Біофарма" повністю забезпечить хворих на гемофілію необхідними ліками". БЦ News (in Ukrainian). Retrieved 2020-08-31.
  33. ^ "Компания". www.moirebenok.ua (in Russian). Retrieved 2020-08-31.
  34. ^ "Запроваджуємо ноу-хау: виробництво ліків – під громадський контроль!". www.ukrinform.ua (in Ukrainian). Retrieved 2020-08-31.
  35. ^ Astaforova-Yatsenko, Nina (May 16, 2020). "Children with Hemophilia Cheritable Foudation" (PDF). Foundation Memorandum.{{cite news}}: CS1 maint: url-status (link)
  36. ^ "Biopharma". www.facebook.com. Retrieved 2020-08-31.
  37. ^ "Сміливий Олег Винник у розстібнутій сорочці показав, як здав кров". ТСН.ua (in Ukrainian). 2020-07-30. Retrieved 2020-08-31.
  38. ^ "ДонорUA. Здай кров - врятуй життя!". ДонорUA (in Ukrainian). Retrieved 2020-08-31.
  39. ^ "NOVA КРОВ". www.facebook.com. Retrieved 2020-08-31.
  40. ^ "Донори крові "прописали" Суми у Книзі рекордів України". www.ukrinform.ua (in Ukrainian). Retrieved 2020-08-31.
  41. ^ "Олег Винник став донором крові і закликав долучитися до доброї справи інших - YouTube". www.youtube.com. Retrieved 2020-08-31.
  42. ^ Gazeta.ua (2020-07-29). "Олег Винник здав плазму для порятунку українців від Covid-19". Gazeta.ua (in Ukrainian). Retrieved 2020-08-31.
  43. ^ "Костянтин Єфименко: Інноваційні рішення в галузі служби крові: пацієнту не потрібно шукати донорів". OBOZREVATEL (in Ukrainian). Retrieved 2020-08-31.
  44. ^ Компанія «Біофарма», яка працює в Україні, долучилася до світової ініціативи розробки ліків від Ковід-19. Відео (in Ukrainian), retrieved 2020-08-31
  45. ^ "Про імуноглобуліни, донорство плазми крові та ліки від коронавірусу — розмова з президентом «Біофарми»". hromadske.ua (in Ukrainian). Retrieved 2020-08-31.
  46. ^ "UFUTURE AND BIOPHARMA SUBMIT COMPLEXES FOR DETECTION OF COVID-19 TO PUBLIC HEALTH CENTER". Ukraine open for business. 2020-03-23. Retrieved 2020-08-31.
  47. ^ "Обладнання для лікарень і продукти для пенсіонерів: як бізнес допомагає боротися з COVID-19". Економічна правда (in Ukrainian). Retrieved 2020-08-31.
  48. ^ Понад 2 000 тестів за добу - нове обладнання для визначення коронавірусу, retrieved 2020-08-31
  49. ^ "Обладнання для лікарень і продукти для пенсіонерів: як бізнес допомагає боротися з COVID-19". Економічна правда (in Ukrainian). Retrieved 2020-08-31.
  50. ^ "CAM reliability and experience for fighting Covid-19". CAM Automatic Machines (in Italian). 2020-05-27. Retrieved 2020-08-31.
  51. ^ Цензор.НЕТ. ""Биофарма" будет производить иммуноглобулин из плазмы крови переболевших Covid-19, - Ефименко". Цензор.НЕТ (in Russian). Retrieved 2020-08-31.
  52. ^ "Biopharma начинает тестировать на антитела к COVID-19". Интерфакс-Украина (in Russian). Retrieved 2020-08-31.
  53. ^ "У Сумах охочих почали тестувати на наявність антитіл до коронавірусу: чому цінна плазма перехворілих". ТСН.ua (in Ukrainian). 2020-04-29. Retrieved 2020-08-31.
  54. ^ "Черкащанка, яка поборола коронавірус, здала плазму для виготовлення ліків - YouTube". www.youtube.com. Retrieved 2020-08-31.
  55. ^ "У Дніпрі збиратимуть плазму крові людей, які одужали від коронавірусу". glavcom.ua (in Ukrainian). Retrieved 2020-08-31.
  56. ^ "Biopharma приєдналася до міжнародного альянсу з розробки гіперімунного імуноглобуліну для лікування COVID-19". Інтерфакс-Україна (in Ukrainian). Retrieved 2020-08-31.
  57. ^ "Biopharma приєдналась до міжнародного альянсу з розробки ліків від COVID-19". UFuture (in Ukrainian). 2020-04-21. Retrieved 2020-08-31.
  58. ^ СпецКор. "Biopharma приєдналась до міжнародного альянсу з розробки ліків від COVID-19 — СпецКор". spec-kor.com.ua (in Ukrainian). Retrieved 2020-08-31.
  59. ^ "https://twitter.com/whitehouse/status/1288919400960188422". Twitter. Retrieved 2020-08-31. {{cite web}}: External link in |title= (help)
  60. ^ "Наказ МОЗ України від 04.05.2020 № 1038 "Про проведення клінічного випробування лікарського засобу, призначеного для здійснення заходів, спрямованих на запобігання виникненню та поширенню, локалізацію та ліквідацію коронавірусної хвороби (COVID-19)"". moz.gov.ua. Retrieved 2020-08-31.
  61. ^ Biopharma Plasma LLC (2020-08-04). "An Open-label Multicenter Randomized Trial to Evaluate the Efficacy of Bioven, Manufactured by Biopharma Plasma, LLC, in Complex Therapy of Patients With Pneumonia Induced by COVID-19 / SARS-CoV-2". {{cite journal}}: Cite journal requires |journal= (help)
  62. ^ Biopharma Plasma LLC (2020-08-04). "An Open-label Multicenter Randomized Trial to Evaluate the Efficacy of Bioven, Manufactured by Biopharma Plasma, LLC, in Complex Therapy of Patients With Pneumonia Induced by COVID-19 / SARS-CoV-2". {{cite journal}}: Cite journal requires |journal= (help)
  63. ^ ""Біофарма" інвестує у будівництво нового лабораторного комплексу $7 млн". Інтерфакс-Україна (in Ukrainian). Retrieved 2020-08-31.
  64. ^ "Biopharma". www.facebook.com. Retrieved 2020-08-31.
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