I have attached your solution. Kindly take a look. Feel free to invite me privately in your future assignments.

1
Name
Institution
Course
Date
Challenges to biological drug development
Introduction
Health care is very delicate in that it is directly involved with the life of human beings
and this is the primary reason why it has to be treated special. Many processes in the health care
sector are not known to many; for instance, how are drugs developed and supplied to people?
This is something that common people do not have an interest in knowing. What most people
care about is the programs in the healthcare sector, visiting hospitals and get treated. Coming up
with a drug is not something that is easy as it involves many long processes that all needs to be
fulfilled before the drug can be supplied to the hospitals and prescribed to the patient. Biological
drug development is an activity that entails long processes. For instance, the source has to be
genuine and reliable, the development processes have to be approved, and the final product has
to meet set medical standards. This is something that is not always easy even though we know at
the back of our mind that all are done for the safety and better of the patients. Biological drug
development as commonly known is a series of various processes that are involved in bringing a
new pharmaceutical or biological drug into the market. This is done from the point where a lead
compound has already been identified through the drug discovery processes. A lead compound
may be any chemical compound that has a biological activity that is likely to treat a given health
complication. This paper comprehensively gives analysis and summary of the various challenges
for biological drug development.
Development of any drug to be used in the health care sector must proceed through
different stages, and this is done for different reasons. These stages are just put in place to ensure
that the drugs produced and supplied in the market are efficacious, safe and have passed all the
recommended regulatory requirements. Most often, coming up with a new drug will start from
the point where the scientists will learn of a biological target which is directly involved in the
biological process that might be of importance to reduce the sufferings of the patient. There are a
variety of targets such as gene, receptors, protein, enzymes and many more. This process will go
through various stages till it reaches the final stage which is the clinical trial. The following
stages show the drug discovery and development processes;
Discovery
This is the first phase of drug discovery and development process, and it starts with target
identification. This is where the researchers will choose a biochemical mechanism that is
involved in the health complication condition observed in patients. This discovery may be done
by drug candidates in the biotech research laboratories, and then will be tested on how they
interact with the drug target. A volume ranging from 5000 to 10,000 molecules for every
potential drug candidate will be subjected to screening processes. These rigorous screening
processes may include proteomics, functional genomics and many more depending on the
available resources and the knowledge of the researcher in the medical field and how to handle

2
machines. Once the interaction of the drug and the target, the researchers will typically validate
the target that they have, and this will be further done by checking on the activity versus the
condition of the illness for which the medicine is developed for. Either one or more lead
compound will be chosen after a careful review.
Product characterization
When the molecules of the candidates show promise to be therapeutic, some
characterization has to be shown. The cha...