Sugars in combination with polyols are more effective at preventing aggregation than sugar or polyol alone, as evidenced by the disaccharide/mannitol formulations maintained native structure better than mannitol only formulations. One reason for this is confounding factors that scientists do not yet fully understandin some studies, for example, the longevity of antibodies targeting the spike of SARS-CoV-2 is shorter than one might expect.1 We lack clear data to understand whether this is a problem for covid-19. 0000066073 00000 n 0000002450 00000 n Since antibodies wane faster in some individuals, the scientists believe re-infection may occur in subsequent waves of infection. Antibodies lasting in the body. All of the vaccines approved so far produce strong antibody responses. Some had been infected up to eight months before the analysis. hbbe`b``3 V* Recent research suggests free methionine may be a particularly useful antioxidant for protein storage [21]. Chemicals, such as detergents like Tween 80, in antibody solutions, may introduce additional photosensitivity to antibodies [26]. Lori says that their experience is consistent with other patients. 0000015693 00000 n Potenza D, Jancek R, Fernndez Tenorio M, Camors E, Ramos Mondragn R, Valdivia H. Melenhorst J, Chen G, Wang M, Porter D, Chen C, Collins M. Vance K, Alitinok A, Winfree S, Jensen Smith H, Swanson B, Grandgenett P, Murphy B, Swarts S, Mueller B, van der Geer P, Manning M, Fitchmun M. Protein instability following transport or storage on dry ice. Commonly used antibody stabilizer from Candor Bioscience contains the same ingredients [12]. But for those who are at risk of serious illness, plus people who cannot safely receive the vaccine, monoclonal antibodies can be lifesaving. The reconstituted antibody can be stored for several weeks at 2-8C or for up to 1-2 years at -20C. PMID: 33408181. For an optimal experience visit our site on another browser. 6 min read Monoclonal antibodies were approved as a COVID-19 treatment by the FDA last year, and again in February and May. However, median T cell levels were 3.6 times lower in those who had the longer dosage interval (the authors note that the relatively low T cell responses in both cohorts in the study may be because of their age). The COVID-19 vaccines appear to make asymptomatic transmission less likely, but monoclonal antibodies do not limit a patients ability to spread the disease. Typically cold storage ( -20 for long term and 4 for short term) is sufficient to prevent significant proteolytic degradation of the antibody. Infusion times can vary. Light exposure can bleach these dyes and dramatically reduce their fluorescence. 2007;850:285-94. 0000009368 00000 n Web19. To receive monoclonal antibodies for treatment, you must have a positive test for COVID-19, have symptoms of COVID-19 and be within 10 days of when your symptoms began. Antibodies in sodium azide solution should NOT be directly used in living cells or in in vivo studies. For example, lyophilized antibodies can be reconstituted by gentle inversion rather than vortexing. 0000010503 00000 n 2013;10:278-9, Szenczi A, Kardos J, Medgyesi G, Zavodszky P. The effect of solvent environment on the conformation and stability of human polyclonal IgG in solution. "There is a lot of excitement," he said. 0000134231 00000 n RELATED: For more up-to-date information, sign up for our daily newsletter. 0000020531 00000 n Scientists hope that COVID-19 will soon be on that list, thanks to two potential applications. Singh S, Zhang J, O Dell C, Hsieh M, Goldstein J, Liu J. Jake Smith, an editorial fellow at Prevention, recently graduated from Syracuse University with a degree in magazine journalism and just started going to the gym. Another study, also a preprint by researchers in the UK, evaluated the difference in peak antibody levels among 172 people over 80 who received the Pfizer vaccine.16 Those who had no previous record of covid-19 infection had 3.5 times more antibodies at their peak if they received their second dose 12 weeks later rather than three weeks later. "But I didn't get a ride on Air Force One. Several residues of the antibodies, especially methionine and tryptophan, have been found to be susceptible to oxidation in the presence of UV light, elevated temperatures or oxygen radicals [17-20], and oxidation of these residues can alter both the stability and the function of the antibodies.While oxidation does not generally present a problem with antibodies used in research, there are antioxidants, such as 2-ME or DTT, that can slow this oxidation. Additional research also has to be done to understand whether these antibodies would be effective against newer variants of the virus. "I didn't pay much attention to it. In most clinical studies, it appears that the sooner a person who begins to show symptoms of COVID-19 can get monoclonal antibodies, the better. Most importantly, professionalathletes must serve as role models and spokesmen for drug free sport and Second part of the great list of Lab test codes (CPT codes) and abbreviations used in medical lab tests worldwide. Patients use these devices two to four times a day so vital signs and symptoms can be screened every day. The center has locations in Barron and Eau Claire. Illustrator: Alan Defibaugh. But convalescent plasma relies on the altruism of blood donors, and blood donations cannot meet the demands of a pandemic. Please speak with your doctor or contact Monoclonal antibodies are made in a laboratory, designed to mimic the natural antibodies found in the body. It can take days to weeks after an infection for your body to make antibodies. Antibody storage 'shelf life' may range from several weeks to many years depending on both the intrinsic properties of the antibody and the storage conditions. "I told them that we were interested in both," says Bob. If the concentration of an antibody is low, stabilizer proteins (sometimes referred to as carrier or filler proteins), such as purified bovine serum albumin (BSA) or gelatin, can be added to a final protein concentration of 1-5 mg/ml (0.1-0.5%). xref For the monoclonal antibodies to work, they must [arrive] at the time the virus is causing the disease. After about 10 days, there isnt much for them to do. Ice crystal formation can destroy protein structure, and thus render antibodies ineffective. Building 31, Room 5B52 For this reason it is best to treat antibody samples relatively gently. 0000133362 00000 n Memory B cells, which make antibodies, increased for a few months after infection This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. It was busy, but operated as a well-oiled machine.". Du C, Barnett G, Borwankar A, Lewandowski A, Singh N, Ghose S, Kiese S, Papppenberger A, Friess W, Mahler H. Shaken, not stirred: mechanical stress testing of an IgG1 antibody. It's not unlike the proverb, "Give a man a fish and you feed him for a day; teach a man to fish and you feed him for a lifetime." Apoptosis. 0000135452 00000 n As of Friday afternoon, the U.S. had reported nearly 3.6 million COVID-19 cases, stretching hospital resources nationwide. Web5 01 Ambig Abbrev CMP14 Default 01 A hand-written panel/profile was received from your office. WebResearch is still ongoing, but studies show that people who had COVID-19 have antibodies for at least five to six months. use ctrl+F for fast search and find your test code. [COVID-19] is caused by the virus itself, and then after a period of time, its caused by the body's overreaction to the virus, Dr. Shoham continues. 0000052899 00000 n Some T and B cells act as memory cells, persisting for years or decades, primed and ready to reignite a broader immune response should their target pathogen arrive in the body again. Webhow soon after monoclonal antibodies will i feel better. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes activate the emergency medical system (EMS), if necessary. Antibodies produced naturally by your body in . 0000070174 00000 n But getting to a ballpark figure, yet alone putting an exact number on it, is difficult, and the results of immunological studies of covid-19 vary. Chemical reactions such as oxidation and proteolytic degradation of proteins do occur at moderate temperatures; however, the frequency of these reactions is much greater at higher temperatures. As an example, though, monoclonal antibody treatment for COVID-19 under Emergency Use These antibodies could help your immune system recognize and respond more effectively to the virus. The effect of oxidation on antibody molecules has been extensively studied, especially for therapeutic antibodies (e.g., [16] ). J Bacteriol. 242 0 obj <>stream I am very pleased the symptoms were less severe after receiving the infusion.". Neutralizing antibodies derived from the B cells of 1918 influenza pandemic survivors, The search for immune responses that stop COVID-19, T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial, Antibody response to first BNT162b2 dose in previously SARS-CoV-2-infected individuals. 0000133786 00000 n According to recent research, the overwhelming majority of people who have COVID retain antibodies against the virus for at least 10 months. A thorough discussion about antibody storage and antibody shelf life. However it is important that the stored polyclonal antibodies should be in high concentration. WebMonoclonal antibodies Last review completed on June 28th, 2021 Antibodies produced naturally by the immune system recognize components of disease-causing agents to mark them for destruction. Many reagent suppliers also provide PBS-only antibodies (without stabilizing additives or carrier proteins such as BSA, or sodium azide, or glycerol), which can be used in conjugation reactions with dyes and enzymes, or in functional/cell assays, or in live-cell imaging experiments. 0000016970 00000 n "The treatment essentially kick-starts your immune system by blocking the virus from getting into your cells. I have plenty of health issues that could complicate this, so he wanted to follow up right away," says Bob. The interaction between water and proteins is critical to the conformational stability of the proteins. Thus buffer salts are generally required in a protein formulation to control the pH and minimize protein degradation during freeze-drying. Of the people who recovered, 95% had immune system memories of the virus that causes COVID-19, SARS-CoV-2. RELATED: This Vaccine Reaction Means You May Have Already Had COVID, Study Says. Monoclonal antibodies work against COVID-19 by attaching to the virus to block it from entering human cells. There is reason to think that immunity could last for several months or a couple of years, at least, given what we know about other viruses and what we have seen so far in terms of antibodies in patients with covid-19 and in people who have been vaccinated. Anti-microbial agents such as sodium azide (NaN3) at a final concentration of 0.02-0.05% (w/v) or thimerosal at a final concentration of 0.01 % (w/v) or ProClin 300 at 0.02% can also be used to inhibit microbial growth. After the antibody infusion, Bob's symptoms continued to improve. Gandhi argues that SARS-CoV-2 is known to mutate relatively slowly, and early studies have found there is still good cross reactivity against new versions of the virus.19 She thinks it is unlikely that the immunity induced by the original vaccines wont be enough to tackle new variants. WebIn 2017 for adults In 2019 for teens (aged 12-17 years) In 2020 for children (aged 6-11 years) In 2022 for young children (aged 6 months-5 years) It targets 2 interleukins, IL-4 and IL-13. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. Very little loss of activity may occur when serum is directly stored for a decade at -20C. In addition, sodium azide interferes with most conjugation reactions, specifically amine group-dependent conjugations. Monoclonal antibody is a new experimental therapy for people at a higher risk of hospitalization due to COVID-19 and is available as part of an emergency use authorization from the Food and Drug Administration. A virus that cannot transmit and infect others has no chance to mutate., Gandhi agrees: Clamping down [on] this pandemic when we know we have the tools to do so worldwide is our first priority, as opposed to thinking about boosters that may not be needed for rich countries.. Instead of targeting microbes, mAbs target the immune cell (or T cell) responses that lead to inflammation and decrease skin barrier function. Other minor complications include fever, rash, nausea, chills, and feeling lightheaded. Additionally samples should be re-equilibrated in a -80C freezer for a couple of days. And these cells have to produce the protein which then needs to be purified. 1987;262:9902-7. "I was feeling like fever was coming on and had a headache. The study group for the Moderna vaccine reported in April that participants in an ongoing clinical trial had high levels of antibodies six months after their second dose.4 A study in the Lancet found that the Oxford-AstraZeneca vaccine induced high antibodies with minimal waning for three months after a single dose.5. Such conjugated antibodies must be protected from light exposure by, for example, storing in dark vials or in vials covered with aluminum foil. However, he noted that the findings of the Labcorp study are still a win. Now, a new study suggests that you may be in the clear for longer than we previously thought. Theres a conundrum, for example, in knowing that T cells help B cells to rapidly make high affinity antibodies on re-exposure. 0000027532 00000 n Bei der Nutzung unserer Websites und Apps verwenden wir, unsere Websites und Apps fr Sie bereitzustellen, Nutzer zu authentifizieren, Sicherheitsmanahmen anzuwenden und Spam und Missbrauch zu verhindern, und, Ihre Nutzung unserer Websites und Apps zu messen, personalisierte Werbung und Inhalte auf der Grundlage von Interessenprofilen anzuzeigen, die Effektivitt von personalisierten Anzeigen und Inhalten zu messen, sowie, unsere Produkte und Dienstleistungen zu entwickeln und zu verbessern. The final measurements were taken at a mean of 86 days after the onset of symptoms ranging from 44 to 119 days. 0000072691 00000 n 1944;47:231-8, Lichstein H. Studies of the Effect of Sodium Azide on Microbic Growth and Respiration: III. He also cited a May study out of the University of California, Irvine, which has not yet been peer reviewed, that found that people who'd received two doses of an mRNA vaccineeither from Pfizer or Modernahad "antibody titers up to 10 times more than when you recover from a natural infection. 0000015278 00000 n Data from the clinical trials of the leading vaccine candidates have found T and B cell reactivity.13, There is some evidence that vaccination can sharpen immunity in people who have previously been infected with SARS-CoV-2 and recovered. Covid-19 is a very new disease, and scientists are still working out precisely how the body fends off the virus. Biologicals. The kit includes a blood pressure cuff, thermometer, pulse oximeter and weight scale. If conjugations is to be performed sodium azide can be removed relatively easily through gel filtration or dialysis, for example, DiaEasy Dialyzer MWCO 1214 kD from BioVision [11]. Therefore, they may not be as protected.. 1944;47:221-30. It can be given to you by a doctor or self-administered and comes either as a By jamming themselves between those spiky parts and your tissue, he says, monoclonal antibodies keep the virus from attaching to you so easily. 0000014191 00000 n endstream endobj 157 0 obj <>/Metadata 32 0 R/OpenAction 158 0 R/PageLayout/SinglePage/Pages 31 0 R/StructTreeRoot 34 0 R/Type/Catalog/ViewerPreferences<>>> endobj 158 0 obj <> endobj 159 0 obj <. Another study published on May 24 in the journal Nature also found promising results that suggest antibodies linger for months. 0000072545 00000 n 0000072152 00000 n No, at least not in the long term. With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital, Patrizia Cavazzoni, M.D., director of the FDAs Center for Drug Evaluation and Research, said in a press release. Both companies began clinical trials in early June, and results are expected in the coming weeks. For increased stability, glycerol or ethylene glycol can be added to a final concentration of 50% and the antibody can then be stored at -20C. Kuebelbeck Paulsen S. Two studies find that COVID-19 antibodies last 8 months. J Chromatogr B Analyt Technol Biomed Life Sci. Attention Editors: Reprint our articles and illustrations in your own publication. 0000125826 00000 n WebThere are treatments available at your local pharmacies that can prevent severe illness, but they need to be taken with 5 days of when you first have symptoms. hb``a`|Abl,7?m``|Lu ,X`3~TFe:W&. Antibodies must be stored at appropriate temperature and pH ranges, and frequently, in the presence of concentrated (~1 M) substances like glycerol or sucrose, in order to retain activity and prevent aggregation. One preprint study from researchers at University College London involving more than 50 000 participants found that 96.4% were antibody positive one month after their first dose of either the Pfizer or AstraZeneca vaccines, and 99.1% were antibody positive between seven and 14 days after their second dose.15 Median antibody levels changed slightly up to two weeks after the second dose, at which point they rocketed. 0000015108 00000 n Thus prolonged exposure of antibody products to light (especially UV light) is not advisable [27]. ", "We feel very fortunate and grateful that science can deliver this treatment for people," says Joyce. Sodium azide inhibits cytochrome oxidase in the mitochondrial electron transport chain and induces apoptosis [10]. 0000019445 00000 n MAIN Fax: 833 336 0705. The treatment is delivered to the body through an intravenous (IV) infusion and depending on the type of mAb treatment you receive, the process can take between two to three hours. 0000133313 00000 n IE 11 is not supported. The three COVID-19 vaccines available in the United States have dominated the conversation for months, but there has also been a major development in the treatment of the disease: Last year (and again in February and May), monoclonal antibodies were approved as a therapy for patients at risk of developing severe disease. When a person is infected with a germ a coronavirus, for example the person's immune system creates proteins called antibodies tailor-made for that specific germ. WebTherapeutic trials will include treatment of patients with SARS-CoV-2 infection, with varying degrees of illness, to block disease progression. Nevertheless, some general guidelines can be applied to increase the shelf-life of your antibodies in storage. Freeze-drying (lyophilization) is the method of choice for long term storage of monoclonal antibodies because lyophilized antibodies are much more stable than they are in solution. Center for Infectious Disease Research and Policy. The immune response after vaccination is much more homogenous, she says, adding that most people generally have a really good response after vaccination. When the storage temperature is below the freezing point for a cryoprotectant-antibody solution, the solution will solidify. However, instead of ice crystal formation, vitrification typically occurs, as in the cryopreservation of cells/embryos with DMSO. Antibodies are generally stored at 4 in clean and sterile glassware or polypropylene tubes. The active ingredients of ProClin 300 are 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT) and 2-methyl-4-isothiazolin-3-one (MIT), inhibitors of Kreb cycle enzymes -ketoglutarate dehydrogenase, succinate dehydrogenase, and NADH dehydrogenase. "We have had several family members come in together to receive treatment. That daring medical response is commemorated annually with the Iditarod dogsled race. 0000011152 00000 n WebMonoclonal antibodies are given intravenously (injected into a vein). But the levels usually remained stable over time. "I feel fortunate that I got the same treatment in Eau Claire as our former president," says Bob with a chuckle. Bob and Joyce say they were surprised at the large number of people receiving infusions when they were at the clinic. However, protease inhibitor cocktails, available from several suppliers, may be added to the antibody solution if proteolytic cleavage becomes a problem. Jeffrey et al. The study found that mild cases of COVID result in lasting antibody protection and that reinfections are likely uncommon. "They are better than the traditional response you get from natural infection.". But lab-made antibodies only target the most crucial, destructive piece of the SARS-CoV-2 virus. Hearst Magazine Media, Inc. All Rights Reserved. 0000027446 00000 n But what are monoclonal antibodies, anyway? found a sugar-to-protein molar ratio of 360:1 was sufficient to provide storage stability of rhuMAb HER2, and the sugar concentration was 3-4 fold below the iso-osmotic concentration typically used in formulations [24]. 0000042739 00000 n Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY.". Detected cases of reinfection are rare.17 Riley thinks that, even if people become infected after vaccination or an initial natural infection, they will probably experience only a mild illness at worst. Helper T cells help recognize pathogens, killer T cells then kill those pathogens, and B cells make new antibodies when your body needs them, explain the experts at Healthline. These added proteins can also help reduce proteolysis of antibodies. 0000135065 00000 n The level of stabilization afforded by sugars or polyols generally depends on their concentrations. "Vaccination in people previously infected significantly boosts the immune response." Conjugated antibodies, especially those with fluorescent labels, should be stored in dark containers or covered in aluminum foil. 0000000016 00000 n Heres everything you need to know about monoclonal antibody treatment for COVID-19, according to expertsplus why you should still seek out the vaccines as soon as possible. However, once the polyclonal antibody is purified, some loss of activity occurs slowly over the years. They slightly decreased six to eight months after infection. 0000043016 00000 n While we aim to keep all of our stories up to date, please visit online resources provided by the CDC, WHO, and your local public health department to stay informed on the latest news. But though these antibodies mimic the infection-fighting work of the immune system, they dont last forever typically, a monoclonal antibody will stick around for a The level of stabilizers used for protein protection during lyophilization depends on the formulation composition, concentration and physical properties of the stabilizer, and its compatibility with the protein. (Note: ethylene glycol is toxic, and must be handled with care.). What supplements should we really be taking? In that case, the antibody treatment wont be effective. 156 0 obj <> endobj 0000010766 00000 n 156 87 The Action of Sodium Azide on Bacterial Catalase. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. The Action of Sodium Azide on Microbic Growth. 0000134182 00000 n Given the long half-life of most A study published in August showed that T cells specific to SARS can remain in the blood for at least 17 years, bolstering hopes that covid-19 immunity could last for decades. savage 110 barrel swap As long ago as September 2018 it was found that the VH-92A's engine exhaust and rotors could cause damage to the White House South Lawn, where The lowest water content is not necessarily the optimal condition, and the residual moisture should be optimized during formulation development. %PDF-1.4 % However, Joyce soon started to feel ill, as well. Glaxo Smith Kline's monoclonal antibody So 2019;: Simon N, Sperber C, Voigtlnder C, Born J, Gilbert D, Seyferth S. Sydow J, Lipsmeier F, Larraillet V, Hilger M, Mautz B, Mlhj M. Deming Y, Filipello F, Cignarella F, Cantoni C, Hsu S, Mikesell R, Chang S, Lamm S. Human health effects of sodium azide exposure: a literature review and analysis. Telikepalli S, Kumru O, Kalonia C, Esfandiary R, Joshi S, Middaugh C. Randolph T, Schiltz E, Sederstrom D, Steinmann D, Mozziconacci O, SCHONEICH C, Antibody Structure and Antibody Fragments, Bispecific Antibodies and Trispecific Antibodies, Histidine Tag and Anti-Histidine Antibodies, no; freeze-thaw cycles degrade antibodies [, Materials and Methods [ISSN : 2329-5139] is a unique online journal with regularly updated review articles on laboratory materials and methods. Such targeted antibodies "stun the virus," Chin-Hong said, adding it could be used as either a preventative, or for those who are already sick with the coronavirus, as a therapeutic in combination with an anti-inflammatory. The day after their positive COVID-19 tests, Bob and Joyce received monoclonal antibody infusions at the same time in the same room at the clinic. This is because it takes most people with a healthy immune system 1 to 3 weeks after getting COVID-19 to develop antibodies. 2005;94:1445-55. Almost everyone had antibodies that block the virus spike protein. Weitere Informationen ber die Verwendung Ihrer personenbezogenen Daten finden Sie in unserer Datenschutzerklrung und unserer Cookie-Richtlinie. 0000072772 00000 n Anal Chem. Donated plasma is infused into patients to give an immediate boost to their immune system. An expert not involved with the study, Kevin Dick, district health officer for Washoe County, Nevada, pointed out to USA Today, "the study also doesn't address if antibodies from a COVID-19 infection can protect against COVID-19 variants." Monoclonal antibodies are currently being developed by several drugmakers, including Regeneron and Eli Lilly. One of the most remarkable things about COVID-19 is how quickly physicians and scientists were able to respond and develop effective treatment for the disease in less than one year. 0000134841 00000 n "A monoclonal antibody infusion is meant Why Did the CDC Change Its Mask Guidelines? Antibodies are now used to treat cancer, rabies, Ebola and some forms of hepatitis. This was before widespread use of antibiotics or a vaccine for diphtheria. Cryoprotectants such as glycerol and ethylene glycol prevent ice crystal formation by inhibiting hydrogen bonding between water molecules, and thus decrease the freezing points of aqueous solutions. 2011;16:425-37. This treatment is also ideal for those who must approach the COVID-19 vaccines with caution, including immunocompromised people, those who are receiving high doses of steroids, transplant patients, and people with certain cancers. Mol Pharm. Studies have shown that people who had COVID have maintained some level of antibody response after the infection leaves their system, though it's still not clear exactly how long those antibodies lastand how thoroughly they protect you from getting sick again. 0000002628 00000 n "We were preregistered, and it went just as planned. Antibodies have been used in medicine as far back as the 1890s, when they were demonstrated to cure diphtheria, a deadly bacterial infection. Upon learning that Bob's co-worker tested positive for COVID-19, the couple made appointments to be tested at Mayo Clinic Health System in Eau Claire. 0000067937 00000 n However, as the COVID-19 pandemic rapidly evolves and the scientific communitys understanding of the novel coronavirus develops, some of the information may have changed since it was last updated. Enhanced protein stability is imparted by the amorphous mannitol due to the inability of mannitol to crystallize during freeze-drying, potentially through hydrogen bonding interaction of the polyol to protein sidechains. Lately, TV commercials have advertised the option for COVID-19 patients and the Biden administration has encouraged its use. 322755: Hepatic Function Panel (7). HRP-conjugated antibodies can be stored in 20-30% serum from horse, adult bovine, calf, or rabbit, or in one of many commercial stabilizers or in a combination of both (Oded Babai, Savyon Diagnostics, Israel). Its still unclear how long protection lasts, but theyll definitely have worn off after 90 days, the FDA notes. In the case of COVID-19, monoclonal antibodies can help your body block SARS-CoV-2 from latching onto your cells. In this case, these antibodies replicate your bodys immune response to COVID-19, blocking or neutralizing the SARS-CoV-2 virus before it can make you severely ill. Increasing sugar/polyol concentration to a certain level may eventually reach a limit of stabilization or even destabilize a protein during lyophilization, so a specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody.