Composed of chains of amino acids, peptides are the building blocks of proteins. Perhaps you’ve already heard that collagen is one of the most important proteins in our skin because it helps our skin to maintain young and energetic. Influenced by age and environmental factors like the sun and stress, collagen would decrease, which accounts for the emergence of wrinkles. Peptides to be used in skin care can send a signal to collagen and prompt the formation of new collagen. Guided by this principle, various types of cosmetic peptide products have been designed and marketed. Next, we are going to focus on anti-pigmentation peptide and eye care peptide.

Anti-pigmentation peptideOur skin color is determined by the melanocyte which produce melanin in dermis layer of our skin. To be more specific, melanin is formed by the oxidation and polymerization of the amino acid tyrosine. When people becomes older, more melanin would be found. Anti-pigmentation peptide is therefore the best natural dark spot corrector that can greatly lighten the spots without damaging your skin.

Researches proved that some polypeptides delivered into human skin might have certain anti-pigmentation effects. For example, a tetrapeptides PKEK (Pro-Lys-Glu-Lys) has been found to have skin whitening potentials. In a study where 39 Caucasian women were enrolled, facial pigment spots significantly faded after 6 weeks under a combined therapy of PKEK another skin whitener called sodium ascorbyl phosphate (SAP).

Using a lightening hyperpigmentation cream is necessary for nearly everyone, even those who don’t have spots yet. Sometimes you might not notice that your skin has already been damaged. In most cases, your face is especially vulnerable to age spots as it is more frequently exposed to the elements than any other part of your body. With the help of anti-pigmentation peptides, a more even, youthful complexion would be maintained in spite of the aging issue.

Other ingredients that could be combinedly used in anti-pigmentation management are dipeptide and hexapeptide. Dipeptide can even the skin tone and make your skin look lighter and younger. Hexapeptide fights wrinkles that are caused by facial muscle movement. Both are helpful in preventing pigmentation from forming.

Eye Care peptideIn skin care, eye care is of great importance as the skin around eye area is particularly fragile. Without proper care, problems like circles, eyelid bags, and puffiness, as well as fine lines and deep wrinkles would occur. All these are common signs of periorbital skin aging. To reduce wrinkles, Botox has been widely administered in the United States. It’s effective and more than 2.6 million people tried in 2014. However, its serious side effects could not be neglected. Therefore, the application of Botox is often questioned regarding to safety issues. In fact, there are some alternative products that could be chosen for periorbital skin rejuvenation in skin care, such as Acetyl hexapeptide-3, a safer replacement of Botox.

In addition to Acetyl hexapeptide-3, there are some other eye care peptides such as Acetyl Tetrapeptide-5, Dipeptide-2 and Palmitoyl Tetrapeptide-7. Acetyl Tetrapeptide-5 behaves well in reducing puffiness under the eyes. It is also believed that Acetyl tetrapeptide-5 can help skin maintain a smooth resilience and ultimately contribute to a more youthful appearance. Dipeptide-2 is composed of valine and tryptophan and often serves as a skin conditioning agent. It is believed to be capable of improving lymphatic circulation.

The Anatomy of a Perfect Batch Record
When it comes to manufacturing pharmaceuticals quality is critical. Following current Good Manufacturing Practices (cGMP) can help ensure that nothing goes wrong, as these practices lay the foundation for creating quality products. In most countries, cGMP is one of the conditions a company must meet to be allowed to sell its products in one jurisdiction or another.

Any deviation from the standard operating procedure could result in the release of contaminated medications or worse, which could result in the loss of an entire batch of product, leading to potential drug shortages and lost profit, among other things.

Types of Batch Records in Pharmaceutical Manufacturing
The batch manufacturing record (BMR) isa document containingthe instructions that must be followed when manufacturing medication. It includes information like product name, weight and count of each component in the medication, a list of all processes and procedures to follow, and the expected yield of each batch. Essentially, the BMR is the template for producing a drug and so it must be followed with precision and care.

What is a Batch Production Record?
Unlike the BMR, which outlines the manufacturing process, the Batch Production Record (BPR) is a complete history of each stage of the pharmaceutical manufacturing process for each lot, or batch, of medication produced. In essence, it’s a kind of checklist to ensure the instructions in the BMR are followed by everyone involved in the manufacturing process. It exists to provide proof that the BMR was addressed, which is key because, as the FDA states in their guidelines, “If it’s not written down, it didn’t happen.”

Why are BMRs so important?
BMRs detail the manufacturing process to ensure it is efficient, successful, and compliant. Those involved in the process have accurate instruction on things like maintenance, product components preparation, and quantities, among other things.

The Anatomy of a Perfect Batch Manufacturing Record
While the details are different for every product that is produced in a manufacturing facility, the required details of a BMR are the same.

Streamlining Batch Records Review with eBMR & What’s Next
Current practices for BMRs involve a lot of paper records (yes, spreadsheets are still considered paper). These, along with being time-consuming to fill out and manage, don’t give manufacturers easy access to invaluable data. Data they can use to streamline processes and reduce costs, while improving the quality of their batch runs.

Batch Management Dashboard

When you combine the information collected during the manufacturing process with data from the rest of the company, you unlock the potential that all of that data contains. By analyzing all of this combined data, it becomes possible to find operational efficiencies that can help streamline the manufacturing process, reduce costs, and help eliminate human error.

Taking steps towards the future
With the right technology in place and a healthy attitude towards digital transformation, it’s possible for pharmaceutical manufacturers to grow their business. It’s not only about creating a better batch production instructions and documentation processes. It’s about growing the bottom line.

Dot Compliance offers a feature-rich quality assurance and batch record management suite with record-fast deployment speeds and cutting-edge analytics capabilities. Contact us for a demo and discover how our quality management system can help you grow your business and maintain compliance.

Recent years have witnessed an upsurge of stem cell research in the biological world due to its great significance in scientific and biomedical studies and in commercial prospects. Basic research, as well as clinical research and trials, has developed rapidly.

Stem cells, as a kind of pluripotent cells with the ability to self-reproduce, exist in embryos, fetal tissues, umbilical cord blood, and some tissues of adult bodies. Especially, embryonic stem cells taken from early embryos have the most potential for differentiation.

If scientists can accurately understand the conditions and mechanisms for differentiation of stem cells into different tissue cells, they can culture those cells in vitro, and then transplant them into patients to repair damaged ones, or even implement organ development for transplantation in vitro.

“This is undoubtedly great news for patients with Parkinson’s disease, Alzheimer’s disease, myocardial infarction, diabetes, and various cancers, immunodeficiency.” Said a senior scientist of Creative Biolabs, a leading service provider of stem cell research.

Although it is foreseeable that stem cell research will definitely improve scientists’ understanding of life and various life-threatening diseases, which will lead to the further development of life science and medical technology, it has been controversial since the beginning.

Among the researches, ones on human embryonic stem cell and its clinical trials have caused the most ethical controversy. Human embryonic stem cellsused for research can be obtained by extra gametes or blastocysts during in vitro fertilization, natural or voluntary aborted fetal cells, blastocysts obtained by somatic cell nuclear transfer technology, voluntarily donated germ cells and embryos made for research purposes, etc. The main disagreement lies in this question: Is the embryo a potential human or is it a cluster of cells available for research?

There is currently no international consensus on whether and how to conduct stem cell research. Even within a country or region, the perceptions of different groups differ. In addition, a country’s policy may not be static and unchanged. The most typical manifestation is the evolution of stem cell research policies in the US.

In 1995, the Republican-led U.S. Congress enacted a ban on federal funding for any research that would lead to the destruction of embryos, which is known as the famous Dickey-Wicker Amendment. By 1999, the Clinton administration stated that embryonic stem cell research was outside the scope of this law. However, in August 2001, Bush delivered his first televised speech since he became the president, announcing a new policy to limit federal funding for human embryonic stem cell research. And then, in March 2009, Obama signed an executive order to lift some restrictions on federal funding. Before signing the order, Obama said that embryonic stem cells can help understand and even cure some serious diseases, and their potential, although not fully known, should never be underestimated.

The whole society still has a strong demand for stem cell research. For many patients with degenerative incurable disease, stem cell research is seen as the only hope. Opponents oppose these studies for the same reason, which mainly focuses on the murder of potential life and human dignity. Proponents argue that early embryos lack a nervous system and sensation, thus it is acceptable to use early embryos for scientific research and medical treatment, and they are trying to make the controversy switch from the moral level into the medical treatment level.

Over the past decades, peptide-based diabetes mellitus treatment has led to a revolution in the treatment of diabetes due to their multi-functional properties. The most studied diabetes-related peptides include Amylins peptide, Chromogranin A, Exendins Fragments, Insulin C-Peptides, Insulin-Like Growth Factors (IGF) and more.

Stop the “sugar tide”

Despite manifesting as a simple disease, diabetes actually takes many forms. Type I diabetes occurs because the autoimmune response destroys beta cells – the insulin-producing cells in the pancreas. On the other hand, type 2 diabetes (T2D) occurs because cells no longer respond to insulin. Little known is monogenic diabetes, which is a rare form of diabetes caused by mutations in a single gene. However, over time, islet β-cell failure and β-cell death are a common feature of all types of diabetes.

Diabetic drugs can help patients control blood glucose levels for a long time, but they can’t cure or improve the health of pancreatic beta cells. Obesity is the main cause of diabetes in the US, while pancreatic β-cell failure is the main cause of diabetes in Asia. Therefore, some research teams believe that stem cells could be used to fight diabetes. Unlike most cells in the body, stem cells have the ability to self-renew and can differentiate into a variety of cell types, including pancreatic beta cells. Therefore, stem cells may be used to replace dead pancreatic beta cells in patients with diabetes, thereby restoring insulin production and glucose regulation in these patients.

hiPSCs and diabetes

Stem cells can be obtained by first reprogramming blood cells and fibroblasts (a type of cell in the skin) of people with diabetes into human induced pluripotent stem cells (hiPSCs), and then, before these hiPSCs can be differentiated into pancreatic beta cells and transplanted back to the patient, gene editing is performed to correct diabetes-related mutations or gene mutations. This approach potentially allows for an almost unlimited supply of islet beta cells for cell replacement therapy. Since what was transplanted is the patient’s own cells, the possibility of transplant rejection is less likely to occur.

In addition to cell replacement therapy, hiPSCs can help elucidate the underlying molecular mechanisms of diabetes. For example, hiPSCs from patients diagnosed with MODY (maturity-onset diabetes of the young, a subtype of monogenic diabetes) is helpful in understanding how genetic networks control pancreatic and liver development. These two organs are essential for normal glucose metabolism.

In addition, by using hiPSCs as a platform for genetic screening, scientists may be able to better divide patients into different treatment groups. At the same time, it is possible to identify new drug targets based on such screening methods. This will make the ideal of precision medicine for diabetes closer to reality as a one-size-fits-all solution is not suitable for all patients, and should be prescribed based on the inherent genetic defects unique to each patient with diabetes.

Research in the future

The use of hiPSCs in genetic screening and drug discovery for diabetes has been performed in many laboratories around the world. On the other hand, therapies involving the replacement of dysfunctional pancreatic beta cells with hiPSCs still have a long way to go before they are approved for clinical use.

It should be reminded that the protocol to differentiate hiPSCs into pancreatic beta cells is not 100% effective, and some residual pluripotent cells may still be latent in differentiated pancreatic beta cells. Hence, if these pluripotent cells were also transplanted with pancreatic beta cells, they could cause teratoma, a tumor that could lead to life-threatening complications.

The exact function of pancreatic beta cells produced by hiPSCs has not been fully verified. Most importantly, they need to function like real human pancreatic beta cells or islets. Otherwise, individuals’ glucose levels will not be properly regulated, leading to health risks. Another concern is the safety of gene editing technologies, such as the popular CRISPR / Cas9 system, in correcting genetic mutations associated with diabetes. Unless bad or unexpected off-target consequences of CRISPR-mediated genome editing can be ruled out, the possibility of using gene-edited hiPSCs for cell replacement therapy may still be limited.

In short, there is a need for close cooperation between laboratories and clinics in the fight against diabetes, so that scientific research can eventually be translated into therapeutic value for patients and society.