Finding the Right Partners Is Key to Success of Monoclonal Antibody Production

Posted on February 5, 2018 in Uncategorized

Biopharmaceutical as a growing industry is not merely conjecture at this point. The BioProcess Technology Consultants in a 2011 report said that the total revenues among biopharma companies surpassed $100 billion in 2010. But the industry is far from peaking as companies are expected to increase their spending to $200 billion by 2015. But there’s a wide gap between the demand for cell line development and the ability of global pharma companies to build new capacities to fill that gaping hole. This issue won’t affect the huge multinationals more than the smaller companies that can no more afford to invest in these facilities nor pick the scraps left behind by the multinationals.

The rise of CMOs

This is the reason why the number of contract manufacturing organizations is growing very rapidly because they enable smaller biopharma companies to compete. Of course huge companies are also outsourcing some of their production needs not only to cut costs but also to ensure that new product lines are religiously being rolled out. In fact, biologics represent more than 3 in 10 drugs in the development stage in the world. Companies have found the value of outsourcing their requirements for cell line development, biosimilars or biobetters.

Expiring patents

It’s easy to think that the market is already saturated with CMOs, but you would be wrong. Between 2011 and 2018, for example, blockbuster biologics (or those belonging to the top 30 biologics) worth $30 billion in Europe alone are scheduled to lose their patent protection. That means a free-for-all frenzy to develop similar products that may be cheaper and better. Whether you can afford to

Working with a pro

There’s an unjust apprehension regarding biosimilars, and maybe you can include there the Biobetters, but this is typically driven by the type of research and development methods being employed as well as the facilities used to manufacture those products.

Therefore it’s paramount that you work with a professional with the track record and the knowhow to deliver your requirements on time and on competitive rates. In a cutthroat industry, it’s important to gain whatever edge you can get and selling cheaper medicine is always a nice marketing come-on. To think about partnering with CMOs for radiolabeled antibody products or cell line development in order to cut costs is a shallow way of looking at it. More than the savings, it’s one way to make sure that whatever drug is being sold in shelves is not compromised by the biopharma company’s decision to cut some corners in safety procedures and quality ingredients.

Monoclonal Antibody – Alternatives for Treating Non-Hodgkin’s Lymphoma

Posted on January 29, 2018 in Uncategorized

Non-Hodgkin’s lymphoma or NHL is a serious affection which occurs due to the presence of B cells (B lymophocytes), a type of white blood cells which usually lead to severe complications such as tumors. Even though, treatments with chemotherapy and radiation are considered effective for many people who suffer from NHL, on the other hand for many pantients these procedures can be very toxic.

In addition to this, specialists have developed in the laboratories a new theraphy to treat NHL, a theraphy known as Monoclonal-antibody which has been proved to be safe and effective for certain patients. As we know the body produces antibodies, substances which have the role to fight against bacteria and viruses. Moreover, monoclonal antibodies have been produced in laboratories like many other antibodies and have the role in producing anti-tumor effects. Since most NHL patients have B cells, treatment with monoclonal-antibodies has brought important results in healing lymphoma and much more they have been prescribed with other toxin or radioactive particles that usually kill cells.

Furthermore, monoclonal antibody treatments usually include medications as Rituxan or Bexxar. First of all, treatments with Rituxan are considered very effective for people who suffer from NHL and may be used for other types of lymphomas too. Rituxan is the only monoclonal antibody treatment approved for NHL and most of the time has been studied in patients that have relapsed low grade NHL. Moreover, it can be taken without other medicines and it is usually given intravenously once a week for 4 weeks. In contrast to other procedures, Rituxin doesn’t offer serious side effects such as hair loss, vomiting, and low blood counts.

Secondly, another monoclonal antibody which is being tested in laboratories is Bexxar. This medicine is a murine monoclonal antibody and doesn’t have a naked form due to the presence of a radiocative iodine molecule which is attached to it. Just like Rituxan, this agent is administered intravenous with the first dose having a trace amount of radioactivity and the second dose containing most of the radioactive iodine. On the other hand, Bexxar has some negative aspects, such as fever, chills or shakes and in some cases NHL patients may have temporary drop in blood counts.

Thirdly, another monoclonal antibody which has been studied as NHL treatments is Oncolym. This agent has been studied in a radiolabeled form like Bexxar and has proved to be toxic like other radiolabeled antibodies. In contrast, LL2 is a humanized antibody, using a naked, unlabeled form as well as a radiolabeled form.

To conclude, monoclonal antibodies can be very effective in treating NHL due to their low toxicity and also the advantage of combining them with each other and also by using them in combination with chemotherapy or other procedures. It is important to say that people who suffer from NHL should be aware of their condition and become well-informed in order to follow the suitable treatment.


Paternal Leukocyte Immunization As Therapy for Excessive Sperm Antibodies

Posted on January 22, 2018 in Uncategorized

There are various factors preventing couples to have children, one of them is because excessive sperm antibodies of the wife. For these cases, PLI (Paternal Leukocyte Immunization) therapy could be an option to quickly have a baby.

PLI (Paternal Leukocyte Immunization) or also known as Husband Leukocyte Immunization Husband (HLI) is treatment to lower sperm antibodies in women who have excessive number of these antibodies.

Excessive sperm antibodies makes it difficult for sperm to get to the egg because it is always rejected and become dysfunctional, so it does not allow for fertilization and pregnancy. Every woman who has been exposed to sperm does have antibodies against the sperm of her husband, but in some women these antibodies overreact.

The cause is the same with people who are allergic, each person has a different response, depending on the individual. Women with high sperm antibodies overreact to proteins on the sperm, so sperm is rejected and become dysfunctional.

PLI therapy is given by injecting husband’s white blood cells to area under the skin of the wife. It aims to reduce the wife sperm antibodies that can be tolerated by the body and allow for fertilization.

The injection is given at least 3 times, each is given every 3 weeks. Serum containing husband’s white blood cells will be injected at the bottom of the mother’s skin. After therapy, patients are advised to do a reassessment of imuno-andrology test. If the result has reached the normal limit then it is not necessary to continue the treatment. If not, repeated therapy can be performed to achieve normal limits.

There are several requirements that must be considered by married couples to be able to perform PLI therapy:

  1. Excessive wife sperm antibodies
  2. Husband is in good health, i.e. a blood test showed that the husband is free from infectious diseases such as HIV, hepatitis and others.
  3. For the wife who has any history of allergy (e.g. seafood allergy), at the time of therapy, the allergy is not in relapsed condition. If therapy is being performed at the time of allergy it can cause an overreaction.

The chance of success in reduction of antibodies can be up to 95 percent, but for the chance of pregnancy depends on the condition of the body, respectively. Difficulty to get pregnant depends on many factors. If it is indeed because of high antibodies then there is high probability you can get pregnant after reduction of these antibodies.

Before PLI therapy was invented, there are 2 ways which are usually conducted to help pair with this problem to get pregnant, that is with the use of condoms and imunosupressor drug.

Women are expected to gradually lower her sperm antibodies by limiting the exposure to sperm by the use of condoms. However, this should take a long time, about 6 months to 1 year. This will be even longer if the wife often eat foods that contain protein allergens.

Another way is to use the imunosupressor drug. Unfortunately, by using this drug all the antibodies in the women’s body will also goes down, not only sperm antibodies. As a result, the wife will often experience illness, and even affect the spinal cord that causes slow blood rejuvenation, lead to osteoporosis, the risk of diabetes, and others.

It is later found that the husband’s white blood cell immunization can lower sperm antibodies exclusively, and keep the other antibodies which are needed. PLI makes good tolerance to sperm.

The wife who has this problem will also have difficulty in getting good result in IVF. This is because the antibodies will not only reject the sperm, but also reject the fetus resulted from fertilization of the sperm. Even if IVF yields successful conception, the percentage of miscarriage is still high. This is because the wife body remained resistant to the fetus.

Women with a history of this problem in the family had a greater risk of experiencing the same thing. A history of certain food or condition allergies also increases the risk of women having excessive sperm antibodies.