0000134231 00000 n Regeneron Pharmaceuticals, Inc. announced 2003;22:175-86, Lichstein H, Soule M. Studies of the Effect of Sodium Azide on Microbic Growth and Respiration: II. Instead of targeting microbes, mAbs target the immune cell (or T cell) responses that lead to inflammation and decrease skin barrier function. 0000065512 00000 n Different stabilizers such as sugars (sucrose and trehalose are the most used stabilizers) or polyols (glycerol and sorbitol) are normally added to the formulations to protect monoclonal antibodies against degradation during lyophilization and storage. RELATED: Dr. Fauci Says These Are the COVID Symptoms That Don't Go Away. If you've already had COVID-19, your natural antibodies may last as long as 20 months, a new study suggests. WebIn the following chart, draw three of your own original pictures to show three different ways that bacteria can be helpful to organisms. "Monoclonals offer a great bridge to a vaccine," Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, said. The presence of sucrose in a formulation can help preserve the native structure of the protein in the solid state and inhibit physical instability during long-term storage [23]. 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. Lovelace B Jr. Pfizer CEO says third covid vaccine dose likely needed within 12 months. Its these cells that make truly long term immunity possible. About half had another type of T cell that kills infected cells. "It hurt so badly.". Nat Methods. Swimming, biking, running through Graves' disease diagnosis, Sleep: An essential element of success for children, COVID-19 care generates gratitude, new career, Ending the pandemic of misinformation, misperception, Masks play critical role in preventing COVID-19 spread, infection, Body mass index of 35 and higher (any age), Immunocompromised due to cancer diagnosis or transplant (any age). 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. Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY.". This is something that Eau Claire couple Bob and Joyce Wachsmuth, know firsthand. Monoclonal antibody treatments are made in the lab and given to people to fight the virus directly rather than helping the body produce its own antibodies. Modification of amino acids. But lab-made antibodies only target the most crucial, destructive piece of the SARS-CoV-2 virus. A well known Nature paper from 2008 found that 32 people born in 1915 or earlier still retained some level of immunity against the 1918 flu strain, 90 years hence.9 That is really profound, she says. 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. Generally, the antibodies should be stored lyophilized until they are needed and reconstitution performed shortly before use. New options are essential because a major staple in our fight against Covid-19, monoclonal antibodies, is expected to be less effective for the new wave. 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. What are monoclonal antibodies and why are they important? Antibodies are Y-shaped proteins naturally created by the immune system to fight disease. They work by binding to a particular molecule, called the antigen, which the immune system has identified as foreign. Each particular antibody Monoclonal antibodies are made in a laboratory, designed to mimic the natural antibodies found in the body. 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. Alissa Eckert / CDC via AFP - Getty Images. 0000006496 00000 n 0000135173 00000 n A vaccine, which would teach the immune system to mount a defense against the coronavirus on its own, is, of course, the ultimate goal. Several months ago, our studies showed that natural infection induced a strong response, and this study now shows that the responses last, says Dr. Daniela Weiskopf at the La Jolla Institute for Immunology. "They are better than the traditional response you get from natural infection.". UNC School of Medicines Myron Cohen, MD, leads monoclonal antibody research efforts as part of the NIH-sponsored COVID Prevention Network. 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. 9000 Rockville Pike, Bethesda, Maryland 20892, U.S. Department of Health and Human Services, NIAID Integrated Research Facility, Fort Detrick, Maryland. response to a vaccine can last for a long time, but these laboratory-made antibodies usually last for only a few months. They've been promoted as a "bridge to a vaccine." It also seems that glycerol may not be necessary for storage at -20C for years or even decades if the antibodies do not go through repeated freeze/thaw cycles. Chin-Hong described monoclonal antibodies as a "force field" around the coronavirus. Bethesda, MD 20892-2094 Both companies began clinical trials in early June, and results are expected in the coming weeks. 0000133362 00000 n The center has locations in Barronand Eau Claire. Following the infusions, Bob and Joyce were required to quarantine as they could potentially still shed the virus to others. Within several hours, Joyce began to feel much better, with no fever, chills or body aches. 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 Argentieri M, Pilla D, Vanzati A, Lonardi S, Facchetti F, Doglioni C. Laskowski T, Hazen A, Collazo R, Haviland D. Rigor and Reproducibility of Cytometry Practices for Immuno-Oncology: A multifaceted challenge. But monoclonal antibodies can provide the immune system an immediate, albeit short-lived, boost to fight off the virus. 2007;850:285-94. As an example, though, monoclonal antibody treatment for COVID-19 under Emergency Use 0000015693 00000 n Its also not a sure thingif you can get vaccinated, you should, since theres no guarantee monoclonal antibodies will stop you from becoming severely ill. Almost everyone had antibodies that block the virus spike protein. Now, a new study suggests that you may be in the clear for longer than we previously thought. Other minor complications include fever, rash, nausea, chills, and feeling lightheaded. But what are monoclonal antibodies? ", "We feel very fortunate and grateful that science can deliver this treatment for people," says Joyce. @Q@ yA5di&" %^ uvC` The Centers for Disease Control and Prevention ( CDC) currently recommends that anyone who received monoclonal antibody therapy wait at least 90 days after COVID These are "the best of the best," Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, said. Infusion times can vary. 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. However, instead of ice crystal formation, vitrification typically occurs, as in the cryopreservation of cells/embryos with DMSO. Albert Bourla, the chief executive of Pfizer, has said that a booster dose will likely be required within 12 months of the second dose.18 There are understandable reasons for this. The Wachsmuths qualified for the monoclonal antibodies due to age and other chronic health conditions that increased their chances of developing severe disease or requiring hospitalization. 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. doi: 10.1126/science.abf4063. But for those who are at risk of serious illness, plus people who cannot safely receive the vaccine, monoclonal antibodies can be lifesaving. A study suggests that peoples immune systems remember COVID-19 for months after recovery. 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. Chris Baraniuk reviews what we know so far. Can people be reinfected with coronavirus? The remote patient monitoring kit was sent to their home the next day. The first is convalescent plasma, an antibody-rich blood product from people who have recovered from COVID-19. 0000008483 00000 n Monoclonal antibodies are not FDA-authorized for hospitalized COVID-19 patients or those who are receiving oxygen, because they wont be able to help much. No, at least not in the long term. Lately, TV commercials have advertised the option for COVID-19 patients and the Biden administration has encouraged its use. 0000000016 00000 n Lyophilization is a good choice to achieve the desired long term storage for antibodies at room temperature. 0000053239 00000 n Lyophilization is a method with poor efficiency, high energy consumption and large investment in equipment. However, optimal conditions for storage are unique to each antibody. Half of the healthcare workers had previously recovered from covid-19 and it was they who experienced the greatest boost in antibodiesmore than 140-fold from peak pre-vaccine levelsagainst the viruss spike protein.14. 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. Theyre not a replacement for the vaccines, but they can be lifesaving. These stabilizer proteins competitively inhibit/reduce surface tension and non-specific absorption to storage tube and pipette surfaces. While the study found antibody-producing cells in people 11 months after they experienced their first symptoms, researchers believe immunity lasts even longer than that, as it has with similar coronaviruses. This is difficult to say definitively. 322755: Hepatic Function Panel (7). Early on, researchers thought that natural immunity to COVID-19 only lasted for about 2 to 3 You have to grow the cells. "I feel fortunate that I got the same treatment in Eau Claire as our former president," says Bob with a chuckle. II. However, once the polyclonal antibody is purified, some loss of activity occurs slowly over the years. COVID antibodies Key Highlights Antibodies against coronavirus remained in the blood of patients with Covid-19 for at least eight months after they were infected, Italian researchers said Tuesday. 0000042739 00000 n The Action of Sodium Azide on Bacterial Catalase. 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. 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. 1987;262:9902-7. These repeated freeze-thaw cycles can substantially reduce the shelf-life of antibodies. However it is important that the stored polyclonal antibodies should be in high concentration. 4/22/2020 FDA grants accelerated approval for this humanized IgG1 monoclonal antibody (mAb) conjugated with 7 or 8 molecules of SN-38, a topoisomerase inhibitor, using hydrolysable linker CL2A. Research has found that use of dry ice during protein storage and transport can cause acidification of the storage solution and potentially protein aggregation (with or without precipitation), especially with acidic proteins (those proteins with pI less than 7) [14]. 2 to 3 weeks. Longitudinal analysis shows durable and broad immune memory after SARS-CoV-2 infection with persisting antibody responses and memory B and T cells. Anal Chem. 0000015278 00000 n "I was feeling like fever was coming on and had a headache. Three months later, it authorized another pair, bamlanivimab and etesevimab, for the same population. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. Complications with monoclonal antibody infusions are pretty uncommon, but some people can have an allergic reaction to it, much like the COVID-19 vaccines. Such conjugated antibodies must be protected from light exposure by, for example, storing in dark vials or in vials covered with aluminum foil. 0000015720 00000 n 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]. Antibodies produced naturally by your body in . how soon after monoclonal antibodies will i feel better elex a special piece consequences; salaire d'un maire en cote d'ivoire. In the case of COVID-19, monoclonal antibodies can help your body block SARS-CoV-2 from latching onto your cells. Pharm Res. Unit 4: Cellular Respiration notes Cellular respiration is 8. amoeba photosynthesis cellular respiration. 2005;94:1445-55. An editorially independent blog, all content is Dereks own, and he does not in any way speak for his This is at least partially due to the cavitation and exposure of proteins in the air [30]. Webhow long after monoclonal antibodies are you contagious. The researchers found that nearly 87 percent of them had antibodies at least 10 months after their infection. RELATED: This Vaccine Reaction Means You May Have Already Had COVID, Study Says. 0000010252 00000 n Another monoclonal antibody treatment, sotrovimab, was approved in May for the treatment of mild-to-moderate COVID-19 in patients above 12 who are at risk of severe COVID-19. A thorough discussion about antibody storage and antibody shelf life. WebAmino acids are organic compounds that contain both amino and carboxylic acid functional groups. Antibodies lasting in the body. The reconstituted antibody can be stored for several weeks at 2-8C or for up to 1-2 years at -20C. Go here to join Prevention Premium (our best value, all-access plan), subscribe to the magazine, or get digital-only access. For more consumer health news and information, visit health.nih.gov. Gronvall said that convalescent plasma contains all of a person's antibodies to a variety of pathogens, not just the coronavirus. Monoclonal antibodies work against COVID-19 by attaching to the virus to block it from entering human cells. Thimerosal was used as a preservative for medicines and vaccines until it began being phased out in 1999 due to concerns about potential toxicity. Epub 2021 Jan 6. (Note, however, that this does not necessarily mean they cannot transmit the virus even if they have mild or no symptoms.). From vegan to keto, which diet has the highest carbon footprint. 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. The researchers also found that people over 65 generally didn't hang on to antibodies as long as those under 65. 6 min read Monoclonal antibodies were approved as a COVID-19 treatment by the FDA last year, and again in February and May. 0000072152 00000 n Extended interval BNT162b2 vaccination enhances peak antibody generation in older people. TUESDAY, Feb. 8, 2022. 1944;47:231-8, Lichstein H. Studies of the Effect of Sodium Azide on Microbic Growth and Respiration: III. In this case, it's antibodies specific to the coronavirus. "Vaccines are highly efficacious," he concluded. Thus, it is advisable to keep antibody concentration high (e.g. In this issue of AnnalsATS, Lee Immune cell levels also remained high. Some monoclonal antibodies Singh S, Zhang J, O Dell C, Hsieh M, Goldstein J, Liu J. 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. 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. (Note: ethylene glycol is toxic, and must be handled with care.). 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. 0000015108 00000 n Synatom Research, Princeton, New Jersey, United States, last modified : 2022-11-16; original version : 2012-10-12, Laboratory equipment: refrigerators and storage vials, Cryoprotectants: glycerol and ethylene glycol, Sterilization and antimicrobial compounds, Mechanical stresses: vortexing, shaking, and vial-dropping, Lichstein H, Soule M. Studies of the Effect of Sodium Azide on Microbic Growth and Respiration: I. nihnewsinhealth@od.nih.gov 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). 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. 0000013349 00000 n 0000066036 00000 n 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. Our material is not copyrighted. Aromatic amino acid residues in proteins can absorb UV-light, and light was shown to induce conversion of Trp to Gly and Gly hydroperoxide in IgG1 [25]. We are currently recording around 60,000 new infections per day in the U.S., and many are occurring among persons who would benefit from monoclonal antibody "But I didn't get a ride on Air Force One. 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. Many commercially available antibody reagents contain one or more additives discussed below that are intended to increase the stability of the antibodies during long-term storage. But in the lab, scientists can pinpoint specific antibodies and then manufacture them en masse. Apoptosis. 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. In some pharmacies How long does natural immunity last after a COVID-19 infection? Why Vaccinated People May Still Get COVID-19, Study: Erythritol May Raise Risk of Heart Disease, Your Privacy Choices: Opt Out of Sale/Targeted Ads. WebBiologics for eczema involves the creation of lab-modified antibodies called monoclonal antibodies, or mAbs (which is why many biologic drug names end in -mab). 1997;86:1250-5, Davies K, Delsignore M, Lin S. Protein damage and degradation by oxygen radicals. There's not much of a bright side to contracting COVID, but people have at least clung to the hope that they'd acquire some immunity after recovering from the virus. Lyophilization involves drying antibodies at a very low temperature, reducing the damage to the products and retaining the molecular integrity. These man-made antibodies are meant to mimic antibodies your immune system begins to make after being exposed to COVID-19," says Lori Arndt, a physician assistant in Infectious Diseasesat Mayo Clinic Health System in Eau Claire. 2008;97:4347-66. Biologicals. COVID-19 treatments enter new testing phase as cases surge in U.S. 0000013658 00000 n 0000067578 00000 n However, a recent article indicates that trehalose or maltitol may not be lyoprotective, at least for pure polyclonal antibdies [4]. 0000013209 00000 n Theres a conundrum, for example, in knowing that T cells help B cells to rapidly make high affinity antibodies on re-exposure. Fluorescence can photobleach when exposed to light. ", That's why those who've come down with COVID are urged to get vaccinated, with the Centers for Disease Control and Prevention (CDC) saying that "experts do not yet know how long you are protected from getting sick again after recovering from COVID-19. "I ached so badly that I was ready to start crying," she says. Table 1 summarizes common antibody storage conditions and other characteristics. It is also reported that monoclonal antibodies can be stored under saturated ammonia sulfate as pellets at 4C or -20C for many years without loss of activity, bacterial outgrowth or oxidation. Cleland J, Lam X, Kendrick B, Yang J, Yang T, Overcashier D, Haywood J, Mozziconacci O, Allegre K, Kerwin B, SCHONEICH C. Light-induced conversion of Trp to Gly and Gly hydroperoxide in IgG1. Lori says it is not uncommon to have family members receive infusion treatments together. Webhow soon after monoclonal antibodies will i feel better. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. "Monoclonals are a refinement" of the convalescent plasma process, Gronvall said, "mass producing it as a purified form.". Center for Infectious Disease Research and Policy. In most situations, freeze-dried proteins can be stored at -20C. In early January, Bob felt like a winter cold was coming on. 0000020531 00000 n Neutralising antibodies are expected to decline in number over time, says Timothe Bruel, a researcher at the Pasteur Institute, given what we know about the immune response to other infections. The study found that mild cases of COVID result in lasting antibody protection and that reinfections are likely uncommon. The mechanism of stabilization by sugars during drying is either that sugars produce a glassy matrix to restrict mobility (glass dynamics mechanism) and/or act as a water substitute (water substitute mechanism). According to Sigma, one of its suppliers, it presents no health hazards, toxicology problems, or disposal issues at recommended usage levels (0.03 0.05%), and thus is considered a safe alternative to sodium azide and thimerosal. When your body produces COVID-19 antibodies after contracting the disease or being vaccinated (these are called polyclonal antibodies), there isnt a universal protective result; different types of antibodies focus on different parts of the virus structure. 0000014245 00000 n This antibody solution should be stored in small working aliquots, for example, 25 ul [6], so they are subjected to fewer freeze-thaw cycles that can denature the antibodies. 0000072545 00000 n 0000011645 00000 n Covid-19 is a very new disease, and scientists are still working out precisely how the body fends off the virus. 0000012130 00000 n 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. Sign up for Yahoo Lifes daily newsletter, This Vaccine Reaction Means You May Have Already Had COVID, Study Says, people who were previously infected with COVID, COVID survivors are protected from reinfection, For more up-to-date information, sign up for our daily newsletter, study out of the University of California, Irvine, Dr. Fauci Says These Are the COVID Symptoms That Don't Go Away, Women who had ovarian cysts share their stories, A sugar replacement may be linked to heart attacks and strokes, but don't throw it out yet. A single dose of REGEN-COV, a combination monoclonal antibody therapy, reduced the risk of COVID-19 by 81.6% several months after a single dose. I am very pleased the symptoms were less severe after receiving the infusion.". While this is exciting news, more research needs to be conducted and more time needs to pass before scientists can definitively determine how long and how well COVID survivors are protected from reinfection, Brian Caveney, MD, Labcorp Diagnostics chief medical officer and president, told USA Today. A study published in February in Science assessed the proliferation of antibodies as well as T and B cells in 188 people who had had covid-19.7 Although antibody titres fell, memory T and B cells were present up to eight months after infection. Antibody preparations should always be sterilized through filtration using a 0.45-micron filter and must be handled aseptically to prevent microbial contamination. 0000014191 00000 n The first evaluation was taken at a mean of 37 days after onset of symptoms, ranging from 18 to 65 days. 0000027446 00000 n WebFda PipelineThe FDA & Alzheimer's: What's Next?. 0000043016 00000 n Under poor storage conditions of 40° for 2 weeks at a typical formulation pH of 6.0, aspartate and asparagine residues within degradation hotspots of the variable Fv region were found to be modified in as many as 39% of antibody molecules [5]. A study published in February in Science assessed the proliferation of antibodies as well as T and B cells in The most commonly used of these antimicrobial agents is sodium azide, which is toxic to most organisms, including humans. 0000002450 00000 n 242 0 obj <>stream 23 Dec 2020. Gunnar Kaasen poses with the dog team which he drove through a blinding blizzard to Nome, Alaska, to deliver a diphtheria serum in 1925. 15 Apr 2021. Light exposure can bleach these dyes and dramatically reduce their fluorescence. 0000071821 00000 n Monoclonal antibodies have been used to treat the following conditions:Cancer.Organ transplant rejection.Inflammatory and autoimmune disorders, including allergies.Infections, including COVID-19.Osteoporosis.Eye conditions.Migraines.High cholesterol.Nervous system disorders. However, he noted that the findings of the Labcorp study are still a win. 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. 2021 Feb 5;371(6529):eabf4063. 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. A letter published in the Lancet in March discussed an experiment in which 51 healthcare workers in London were given a single dose of the Pfizer vaccine. While it's unclear how long the immune boost from the monoclonal antibodies would last, infectious disease experts are hopeful. 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. 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). Let's be honesthe's probably scrolling through Twitter right now. All of the vaccines approved so far produce strong antibody responses. hbbe`b``3 V* For example, lyophilized antibodies can be reconstituted by gentle inversion rather than vortexing. 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. 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. Many stability studies are performed using iso-osmotic concentrations of sugars (e.g., 275 mM sucrose or trehalose).