Biopharmaceuticals - Science topic

I think you should approach companies directly. For instance, you can take appointments and convince them to research your desired topic. Most of the companies welcome appointments, so try that way.

Plant proteins are proteins that are produced by plants or derived from plant sources. Plant proteins can be used to create biosimilars of monoclonal antibodies and other therapeutic proteins that are used to treat various diseases, such as cancer, HIV/AIDS, Ebola, etc.

There is some research going on plant proteins that are similar to biosimilars. For example, scientists have created plant biosimilars of trastuzumab and pertuzumab, which are antibodies that target the human epidermal growth factor receptor 2 (HER2) in breast cancer cells (1). They have also modified the Asn297-linked glycan of the antibodies produced in a plant with fucosyltransferase and xylosyltransferase gene knockouts to improve their biological activity.

Another example is PlantForm, a Canadian biotech company that has turned to tobacco plants to create monoclonal antibodies and proteins to treat cancer, HIV/AIDS, Ebola, and other diseases. They have three biosimilar candidates for Herceptin (trastuzumab), Avastin (bevacizumab), and Humira (adalimumab) (2).

(1) The biological activity of bispecific trastuzumab/pertuzumab plant .... https://www.nature.com/articles/s41598-019-52507-9.

(2) “Growing” Biosimilars How Plants Bolster Manufacturing Efficiency. https://www.biosimilardevelopment.com/doc/growing-biosimilars-how-plants-bolster-manufacturing-efficiency-0001.

Emerging technologies hold transformative potential for the future of medicine. Personalized medicine and precision therapies, catalyzed by genomic and proteomic technologies, can provide treatments tailored to individual patients. Artificial intelligence, inclusive of quantum machine learning, could revolutionize diagnostics and predictive modeling, potentially improving vaccine design by accelerating antigen discovery and reducing time to deployment. Nanotechnology promises targeted drug delivery, minimizing side effects. Biomanufacturing advancements, including 3D bioprinting, could reshape organ transplants by creating patient-specific organs. Digital health platforms and wearable technology are poised to enhance continuous patient monitoring and proactive health management. As such, we can expect these technologies to contribute significantly to the evolution of healthcare and pharmaceutical industries.

I don't know much about the pharmaceutical industry because it's not my field.

Every country has its own IPR regulation. Check the Patent databases of your target countries.

One method is to pass the exhaust gas through a packed bed catalyst. The pressure drop might be high but the decrease in concentration is good enough. You can controlled the rate of decomposition by multiple factors such as the packing density, the size of the granulars, the type of catalyst, the flow rate, ...etc. A Pt/Pd coated alumina granulars are common and easy to find in the market.

Word of advise, don't use a catalytic converter >> the turbulence in the flow is low so the rate of decomposition is low.

Nice Dear Alireza Jafari Arimi

I do not think there are many companies out there that change the host system between clinical trials and manufacturing for Phase III and onwards.

The differences in hosts could force you to restart the whole process development process, as the host-related impurity profile could be quite different, esp. for HCP, but even things like potency and activity could be affected. If you run into this problem, you will be forced to perform at least some clinical bridging studies to show that the drug produced with the new host is the same or very "biosimilar" to the one you used for the initial clinical studies.

If you then run into problems of not being able to demonstrate this similarity, you are thrown back to square 0. The biggest cost for the drug owner is not the financial aspect, but the time lost to get to market.

Hello,

Grand Challenges in biological engineering in general can be formulated as follows

1. Develop carbon sequestration methods.

2. Manage the nitrogen cycle.

3. Provide access to clean water.

4. Advance health informatics.

5. Engineer better medicines.

6. Reverse-engineer the brain.

7. Engineer the tools of scientific discovery.

Partially in biopharmaceutical engineering are drug design and discovery, natural products, formulation design and pharmaceutical technology, alternatives to antibiotics and new approaches against antibiotic resistance etc.

Hi there,

The main drawback of cerevisiae is that secreted proteins are most of the time hyperglycosylated and are more immunogenic when injected. For more info, see the 2 links below:

OK, Thank you so much for your time..

Dear Dr. Blasko,

Thanks for your valuable suggestion!

I loaded much more conc of sample for example 0.2g in 10mL - 50 fold, in terms of method detection capability is absoulutely fine. I am bit worried about RSD (approx 20%). Using C6 column and alredy tried with Phenyl Hexyl column, it seems that C6 is better. It would be great if i get information or tips on sample preparation as this compound is highly sensitive to heat and pH and other environmental factors.

make your formulation, but the quantity of inactive ingredients should be safe, you can follow the link

to add:

from a manuafacturing and quality control perspective - one would almost turn to a molecule without variable glycosylation (a-gly) if possible (if it has the same functional activity) to avoid variability between batches of the product.

You can work on niosomal drug delivery system as lot of research has been done for improving permeability of class III drugs via niosomal approch. Nonionic surfactants based vesicles have shown promising results for this issue.

@ Dr. Manoj : I am interested in the process( analytical method )  to do it. Moreover, if i do karl fischer analysis on my samples i get a value containing all the water content.

You can use the book "Piping and Pipeline Calculations Manual" to me has helped me. In conclusion I think you should consider the following:

- Theoretical needs of the productive system.

- Type of fluid: related to auxiliary systems and process lines.

- Type of material: to define friction losses, pressure drops.

On many occaisions, a drug company will release an experimental drug to a patient under "Compassionate Use" provisions (which include fully informed consent as to the experimental nature of the drug or product).

In my personal experience bacteria are just easier to work with. Selections are easy and its possible to make loads of protein (100+ mg/litre shaking culture), especially if fermentors are used. If it works in bacteria, its the way to go. Also, the available strains of bacteria with different traits is quite diverse nowadays to overcome different problems. There's also a lot of different media and working habits to control expression, protein stability and solubility etc.

However, membrane proteins, glycosylated proteins, proteins with a lot of disulfides and massive single-domain proteins can prove to be very challenging to work with in bacteria. And of course, in science its not always the goal to make as much protein as possible but to make what is relevant. There's no point in producing misfolded or unfolded protein for biochemical or structural studies if that is not the (near-)physiologically relevant form. Yeasts, insects and other eukaryotic systems come into the picture here, but these are much more laborious. S. cerevisiae, for instance, can be very handy with membrane proteins, but selection is difficult. One can use synthetic media (which are very expensive and the cell growth is not very fast) to select but to be able to produce adequate amounts of protein one usually ends up using complex media (like YPD) and then loses selection. This is a major problem with other than integrative plasmids, as plasmid stability in yeast is quite often low. Insect cells (Sf9, Sf21 etc) require already much more culture upkeep and maintenance although the baculovirus system has worked quite well for my colleagues. Mycoplasma is a problem, as for all eukaryotes. Also, the glycosylation performed by insect cells is not always the same as in mammalian systems, for example.

In vitro translation then... well it does translate but there are no PTM's unless you supply the reaction with the machinery capable of these. Also, since it's a cell-free system, there is practically nothing present that degrades your protein. I guess it's quite difficult to produce bucketloads of protein with cell-free systems.

according to me,Market exclusivity, only precludes a second sponsor (that is you in your case)from obtaining approval to provide an identical drug for the identical orphan indication for which the first sponsor received exclusive market approval.you can get the approval of different orphan drug for same orphan i.e rare disease which the first sponsor is treating...