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.

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Bioavailability Production Manufacturing Drugs 52

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.

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Bioequivalency Production Genotoxicity In-Vivo 169

Drug Discovery World

AUGUST 3, 2022

CDMO in peptides and oligonucleotides manufacturing, Bachem, has started building a new future for oligonucleotides: solving the industry’s main challenges around capacity, sustainability and cost-effectiveness. Ensuring that the CPP can escape this endosomal compartment is crucial for its bioavailability and bioactivity properties.

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Bioavailability In-Vivo RNA In-Vitro 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.

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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.

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Protein Bioavailability Development Scientist 130

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].

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Drug Delivery Systems Drug Delivery Drugs Bioavailability 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.

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Drug Delivery Drugs Bioavailability Marketing 40

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 –.

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Protein Drug Delivery Drugs Drug Delivery Systems 52

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.

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Manufacturing Production Packaging Packaging 130

Pharmaceutical Technology

JUNE 26, 2022

As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development.

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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.

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Containment Bioavailability Clinical Trials Clinical Trials 52

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.

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Bioavailability In-Vivo In-Vitro Licensing 130

Drug Discovery World

DECEMBER 7, 2022

Different polymorphs of the same active pharmaceutical ingredient (API) can have profound effects on solubility, permeability, and bioavailability, as well as manufacturability. In 1998, two years after Norvir’s release to market, a second polymorph created during manufacturing was discovered.

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Bioavailability Manufacturing Production Development 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.

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Big Data Medicine Marketing Clinical Trials 40

Pharmaceutical Technology

NOVEMBER 24, 2022

Few contract development and manufacturing organizations (CDMOs) are able to provide radiolabeling services as part of a fully integrated pharmaceutical development program. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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Bioavailability Manufacturing Drugs Production 130

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.

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Bioequivalency Bioavailability Regulation Drugs 52

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.

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Development Research Manufacturing In-Vivo 201

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.

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Development Production Manufacturing Bioavailability 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.

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Drugs Manufacturing Drug Delivery Production 52

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.

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Development In-Vivo Clinical Trials Clinical Trials 130

Drug Discovery World

FEBRUARY 2, 2023

As reported by DDW , the system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

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Drugs Clinical Trials Clinical Trials Cosmetics 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….

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Packaging Packaging Production Bioavailability 52

Drug Discovery World

AUGUST 12, 2022

These can have better properties than their parents, including preferable stability, solubility, bioavailability, and manufacturability. Some 5% of commercially available research compounds aresold as salt forms.

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Drugs Bioassay Development Research 52

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.

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Manufacturing Production Containment Contamination 130

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.

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Production Containment Bioavailability Manufacturing 130

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.

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Contamination Manufacturing Containment Production 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.

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Development Drugs Bioavailability In-Vivo 246

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.

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Containment Manufacturing Contract Manufacturing Bioavailability 130