Pharmaceutical Technology

MAY 31, 2023

CFT8919 is an orally bioavailable BiDAC degrader designed to exhibit potent and selective activity against EGFR L858R in patients with non-small cell lung cancer (NSCLC). Betta will be responsible for the development, manufacture and commercialisation of CFT8919 in the licensed territories.

In-Vivo 130

In-Vivo Bioavailability In-Vitro Licensing 130

Camargo

FEBRUARY 10, 2021

A failure to demonstrate BE may suggest that the test product should be reformulated, that the manufacturing method should be changed, that additional safety or efficacy data may be needed, or that the study was not properly powered for sample size.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

XTalks

DECEMBER 5, 2022

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2

Bioavailability 97

Bioavailability FDA Approval Trials Drugs 97

Roots Analysis

MARCH 13, 2022

Therefore, a variety of excipients, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage. Additionally, biopharmaceutical excipients act as bulking agents, antioxidants or preservatives.

Manufacturing 52

Manufacturing Drug Delivery Marketing Drug Delivery Systems 52

XTalks

JUNE 27, 2024

Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand. Kinetisol™ Technology represents a significant leap in amorphous solid dispersion development and manufacturing. This method is environmentally sustainable and fast, taking seconds instead of hours or days.

Bioavailability 59

Bioavailability Manufacturing Drugs Development 59

Camargo

DECEMBER 22, 2021

In addition to prioritizing programs most closely aligned with sponsor objectives, a portfolio analysis can help prevent a program from failing due to misalignment of the various factors that affect drug development, including clinical, nonclinical, regulatory, scientific, manufacturing, and market dynamics. Fine-Tuning Strategic Assessment.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Roots Analysis

FEBRUARY 20, 2022

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

Pharmaceutical Technology

AUGUST 3, 2022

During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.

Development 130

Development Production Manufacturing Bioavailability 130

Cloudbyz

MARCH 5, 2024

Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability. The conditions affecting the living system can influence the final product, making the manufacturing process more sensitive and challenging.

Development 97

Development Drugs Immune Response Manufacturing 97

FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

The Pharma Data

JANUARY 7, 2021

Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs). The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs.

Bioavailability 52

Bioavailability Production Manufacturing Drugs 52

XTalks

FEBRUARY 25, 2022

The first-of-its-kind certification , which launched last year, allows food and beverage manufacturers that use upcycled ingredients to place the claim on their packaging. EverGrain’s UFA Certification. EverGrain launched last year with one simple strategy: to utilize barley to its full potential.

Production 98

Production Protein Branding Bioavailability 98

Pharmaceutical Technology

JANUARY 25, 2023

According to a whitepaper from contract research, development and manufacturing organisation Syngene, PROTACs are effective against “undruggable” targets such as transcription factors, and scaffolding proteins that cannot be otherwise targeted by the traditional small molecule inhibitors.

Protein 130

Protein Bioavailability Development Scientist 130

Pharmaceutical Technology

FEBRUARY 13, 2023

Quotient Sciences was asked to select the best candidate based on material science and oral bioavailability considerations. Access to increasing quantities of drug substance becomes more critical at this stage, and it is important to consider the feasibility of Good Manufacturing Practice (GMP) suitable for early development.

Development 130

Development In-Vivo Drugs Clinical Trials 130

The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Development of oral biosensor and contract development & manufacturing. Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

Drugs 52

Drugs Manufacturing Drug Delivery Production 52

Roots Analysis

MAY 21, 2024

In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.

Drug Delivery 40

Drug Delivery Drugs Gene Therapy Bioavailability 40

Roots Analysis

MARCH 1, 2022

This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration. Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. Web: [link].

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Bioavailability 52

Roots Analysis

MARCH 2, 2022

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. For further information on this domain, check out the report –.

Protein 52

Protein Drugs Drug Delivery Drug Delivery Systems 52

Roots Analysis

OCTOBER 2, 2023

Additionally, it increases the bioavailability and solubility of the attached molecule. Further, outsourcing to players having expertise allows the companies to establish good manufacturing process (GMP) conditions for nanoparticle formulation.

Drug Delivery 40

Drug Delivery Drugs Bioavailability Development 40

The Pharma Data

JANUARY 3, 2021

1 Good Manufacturing Practice. Nanoform’s capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Edward Hæggström, CEO. edward.haeggstrom@nanoform.com. 358 29 370 0150. 46 7686 650 11.

Containment 40

Containment Bioavailability Clinical Trials Clinical Trials 40

XTalks

AUGUST 8, 2024

Dr. Dieterich has a PhD in synthetic organic chemistry, an MBA from Imperial College London and a wealth of experience in drug development and chemistry, manufacturing and control (CMC) activities. Despite their potential, oligonucleotides present challenges in bioavailability due to their large, hydrophobic and negatively charged nature.

Development 64

Development Medicine Antibody Protein 64

FDA Law Blog

JULY 6, 2021

The CRL was issued on July 21, 2020 on Nostrum’s Prior Approval Supplement ANDA seeking approval to move its manufacturing facilities.

Bioequivalency 52

Bioequivalency Bioavailability Drugs Regulation 52

The Pharma Data

MAY 14, 2021

Plus considering that it takes our manufacturing facility 3 whole months to source and produce just a single batch of ProstaStream and that each capsule contains the purest and most bioavailable form of these prostate-supporting power foods in existence….

Packaging 52

Packaging Packaging Production Bioavailability 52

Roots Analysis

JANUARY 28, 2024

Some of the areas she has worked on include protein design and engineering, metabolomics services, bioavailability enhancement technologies and services, plasmid DNA manufacturing, NAMPT inhibitors, and big data analytics in healthcare domain.

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

Camargo

SEPTEMBER 30, 2021

The drug development process can be broken down into three main disciplines: chemistry, manufacturing, and control (CMC); nonclinical; and clinical. CMC programs include drug substance manufacturing process scale-up, stability testing, early formulation development, and, later on, manufacturing process validation, among other considerations.

Development 201

Development Research Manufacturing In-Vivo 201

Pharmaceutical Technology

FEBRUARY 3, 2023

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

Contamination 130

Contamination Manufacturing Containment Production 130

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

Manufacturing 130

Manufacturing Production Containment Contamination 130

Pharmaceutical Technology

JUNE 14, 2023

Drugs with a high potency are toxic even in small doses, and present a threat to human health, or run the risk of coming into contact with other drugs while being manufactured and compromising the quality. Of those, only 935 (34%) small molecule API facilities offered some type of containment capabilities.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130

Pharmaceutical Technology

FEBRUARY 23, 2023

How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. In Part 3 of the study, which investigated relative bioavailability and food effect, the SDD tablet was assessed in the fed and fasted state and compared back to the reference SDD suspension.

Development 246

Development Drugs Bioavailability In-Vivo 246

Pharmaceutical Technology

MARCH 21, 2023

Considering renewed interest and high demand of CBD, Frewitt, an innovative manufacturer of premium-quality mills and a world leader in powder size reduction technologies, recently conducted tests in partnership with Cannawyss to ascertain the best milling methods and equipment for CBD crystals. [i]

Production 243

Production Bioavailability Pharmacy Clinical Trials 243

Pharmaceutical Technology

MARCH 7, 2023

Each of the aforementioned factors, alone, or with several combined, can offer manufacturers a unique challenge to obtaining a desired dosing rate or satisfactory product flow. Maintaining dosing accuracy One company that is leading the way in powder products and dosing accuracy is Frewitt, an innovative manufacturer of premium-quality mills.

Production 130

Production Containment Bioavailability Manufacturing 130