XTalks

AUGUST 25, 2023

The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens.

Allergies 98

Allergies Manufacturing Contamination Production 98

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Pharmaceutical Technology

APRIL 4, 2023

There are 13 sites in the region that offer API biologic services and 12 of these are based in Telangana, all offering protein and peptide manufacturing, and one – Loka Biosciences (Hyderabad, Telangana, India) – also offers gene therapy production. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023).

Manufacturing 130

Manufacturing Generic Drugs Contract Manufacturing Production 130

Roots Analysis

OCTOBER 24, 2023

The ADCs bind to specific proteins or peptides in cancer cells with very high specificity and efficacy influencing the biological functions. A molecule having 2-50 amino acids is considered as peptide whereas, group of peptides are responsible for forming a protein.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

XTalks

JULY 25, 2023

While there is no evidence of person-to-person transmission, anthrax skin lesions may be contagious through direct contact or contaminated objects. The bacteria usually enter the body through wounds, but infection can also occur through contaminated meat or inhalation of spores.

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

Roots Analysis

OCTOBER 24, 2023

The limitations of stainless-steel bioreactors such as high risk of contamination, process related challenges and high operational cost have prompted innovators to develop more advanced single use bioreactor in order to meet the rising demand for safe and efficacious biotherapeutics.

Manufacturing 40

Manufacturing Contamination Marketing Production 40

pharmaphorum

JULY 21, 2022

If businesses have received a notice of inspection, they should focus on two key things: Adulteration: proof there is no chemical, microbial, viral, or other type of contamination in products. However, we understand that this is not always possible. Implementing Pharmaceutical Quality systems.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

Pharmaceutical Technology

JULY 22, 2022

Schistosomiasis, also called the snail fever, is caused by parasitic flatworms that enter the human skin when individuals come in contact with contaminated water, the article noted. Long-term infections can cause damage to the liver and kidneys, and can cause infertility and bladder cancer.

Vaccination 130

Vaccination Vaccine Life Science Immune Response 130

Camargo

NOVEMBER 29, 2021

Recombinant therapeutic proteins. Fusion proteins. They may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system.

Development 180

Development Protein Production Hormones 180

Drug Discovery World

APRIL 25, 2024

Grand View Research states that the market for cell lines is currently bolstered by the fact that the majority of biopharma companies use cell lines to synthesise recombinant monoclonal antibodies and proteins. Looking towards the future Technological advances are helping drive efficiencies in cell line development.

Development 59

Development Protein In-Vivo Life Science 59

XTalks

SEPTEMBER 20, 2023

Plant-based meats, on the other hand, are often derived from pea or soy proteins and mimic the taste and texture of conventional meats. The mixture uses the mass-produced plant proteins with the essential ingredients needed for cultivated meat production. Despite their environmental advantages, some challenges remain.

Contamination 64

Contamination Protein Production FDA Approval 64

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

Production 52

Production Gene Protein Vaccination 52

Drug Discovery World

FEBRUARY 28, 2023

mRNA enables the delivery of a transiently expressed genetic molecule that is translated into a target protein using the machinery of the host cell. Therefore, the risk for off-target insertional mutagenesis is greatly reduced. In addition, it may be easier to target the therapeutic molecule to the correct cell or tissue.

Genetics 52

Genetics Genetic Analysis Vaccination Vaccine 52

Roots Analysis

OCTOBER 16, 2023

Biopharmaceutical filtration is a critical step in the production of biopharmaceuticals, including proteins, antibodies, and vaccines. It involves the separation of unwanted particles from biological materials to obtain contaminant free products. For example, ultrafiltration retains proteins, allowing other molecules to pass through.

Bacteria 40

Bacteria Production Contamination Protein 40

Drug Discovery World

AUGUST 10, 2022

To overcome this evasion tactic, the CAR protein was developed to recognise other markers on cancer cells. CAR is a fusion protein composed of an extracellular antibody fragment that recognises antigens and an intracellular domain that directs the T cell to the tumour. Identifying the right CAR T cell target.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

XTalks

FEBRUARY 8, 2024

for a one-month supply Why it did so well: Jardiance belongs to a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, inhibiting the SGLT2 protein in the kidneys to lead to the excretion of excess glucose through the urine. Jardiance brought in $2.06 billion for Eli Lilly and $6.23 billion for Boehringer Ingelheim.

Sales 52

Sales Insulin FDA Approval Drugs 52

Drug Discovery World

NOVEMBER 1, 2023

Ruizhi Wang, Chief Executive Officer of Abselion will explain how the company’s Amperia benchtop instrument can be used for protein quantifaction and binding assay. Wang will also discuss the automation and compatibility features of the instrument.

Life Science 52

Life Science Contamination Gene Therapy Manufacturing 52

XTalks

JUNE 22, 2023

The factsheet also brings attention to the issues of paper packaging, asserting that it can have a significant toll on forest resources and is not always recyclable due to contamination by food or coatings of plastic and aluminum. The success of The Better Bagel reflects the growing market demand for low-carb and keto-friendly products.

Packaging 52

Packaging Packaging Containment Contamination 52

XTalks

NOVEMBER 7, 2022

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. Exosomes are extracellular vesicles that contain molecular cargoes (such as various proteins, RNAs and DNAs) specific to the origin cell.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

AUGUST 7, 2023

Transmission of the molluscum contagiosum virus occurs through direct person-to-person contact or via contaminated objects known as fomites. It then activates enzymes known as neutral serine proteases, which are responsible for protein degradation.

FDA Approval 98

FDA Approval Dermatology Clinical Trials Clinical Trials 98

Drug Discovery World

FEBRUARY 2, 2023

RRx-001 directly and irreversibly binds to a specific amino acid cysteine residue on a protein complex called the NLRP3 inflammasome, which serves as the “on switch” for inflammation.

Manufacturing 52

Manufacturing Clinical Trials Clinical Trials Drugs 52

XTalks

MAY 13, 2022

This highly sensitive method even works to detect package defects clogged by product formulation proteins or salts, explains Liss. E&L testing is performed to substantiate that packaging materials will not contaminate the drug product over a product’s shelf life. These compounds thus become a part of the drug matrix.

Packaging 98

Packaging Packaging Containment Production 98

Drug Discovery World

FEBRUARY 8, 2023

This helps ensure a high concentration of loaded capsids and adequate removal of impurities, such as host cell proteins and DNA. The threat of empty capsids Capsids are the protein shell that would usually enclose the genetic material of a virus. A crucial part of the AAV workflow is the purification of viral vectors.

Gene Therapy 52

Gene Therapy Gene Antibody Production 52

Pharmaceutical Technology

MAY 17, 2023

In addition to revolutionising diabetes care, insulin has become an essential component of biopharmaceutical manufacturing, where its growth-supplementing ­­­properties are relied on to enhance commercially available cell culture media and achieve higher yields of target therapeutic proteins. One big challenge is contamination.

Insulin 130

Insulin Production Manufacturing Contamination 130

The Pharma Data

MAY 4, 2021

In February 2021, Pfizer and BioNTech announced results from an in vitro study published in NEJM that demonstrated sera from individuals immunized with BNT162b2 neutralize SARS-CoV-2 with the South African variant spike protein. The study investigated the full set of South African variant (also known as B.1.351

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

APRIL 16, 2023

Yet PFSs also come with a challenge such as presenting difficulties in maintaining the stability of protein-based molecules or complex monoclonal antibodies. Protein aggregation and particle formation 5 can occur due to silicone oil-water and air-water interfaces, making the siliconisation of the primary container crucial.

Protein 130

Protein Containment Drug Delivery Drugs 130

Pharmaceutical Technology

APRIL 27, 2023

Every stage of development should result in a reproducible, safe drug product with no cross contamination from one batch to another. The risk of contamination is particularly important for genomic medicines in which trace amounts of nucleic acids would impact the quality of the drug product.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130

XTalks

SEPTEMBER 14, 2020

The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. The University of Oxford/AstraZeneca partnership, in turn, is testing a viral-vectored coronavirus vaccine that again expresses the spike protein of SARS-CoV-2 virus.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92