Library

Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Content provided by Almac Group | 29-Nov-2023 | White Paper

Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...

Almac Group releases 2023 Corporate Social Responsibility Report

Content provided by Almac Group | 14-Nov-2023 | Application Note

Almac Group today announces the release of the company’s 2023 Corporate Social Responsibility report, which highlights Almac’s progress and commitments...

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges

Content provided by WuXi AppTec | 01-Nov-2023 | Application Note

The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical...

Let your Senses Guide you into the world of Art & Science: Meet with Funtrition & Sofgen during Supply Side West 2023

Content provided by Sofgen Pharmaceuticals | 26-Oct-2023 | Application Note

Procaps Group, a leading integrated LatAm healthcare and pharmaceutical services company,

Three ways to leverage AI in Clinical trials right now

Content provided by Saama | 25-Oct-2023 | White Paper

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ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation

Content provided by WuXi AppTec | 20-Oct-2023 | Application Note

Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders...

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Why should you use clinical trial technology?

Content provided by Formedix | 16-Oct-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape.

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

PBPK modeling that saves you time and money

Content provided by Lonza Small Molecules | 09-Oct-2023 | White Paper

Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug...

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

In vitro evaluation of the gastrointestinal delivery of acid-sensitive pancrelipase in a next generation enteric capsule using an exocrine pancreatic insufficiency disease model

Content provided by Lonza Capsules & Health Ingredients | 27-Sep-2023 | White Paper

International Journal of Pharmceutics: In Vitro: The dissolution characteristics of five capsules (Next Generation Enteric [NGE], Vcaps® Enteric [VCE],...

Unlock potential in buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 18-Sep-2023 | Infographic

Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.

In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule

Content provided by Lonza Capsules & Health Ingredients | 01-Sep-2023 | White Paper

Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach....

ReciBioPharm - An optimized Plasmid DNA platform to accelerate the path to clinic and commercialization

Recipharm AB | Recorded the 14-Sep-2023 | Webinar

Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity
Customizing the downstream process to...

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Plan for success with process liquid and buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 14-Aug-2023 | White Paper

Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...

How enhancing equipment reliability supports quality, efficiency, and operational excellence

Content provided by Bora Pharmaceuticals | 10-Aug-2023 | White Paper

Successfully manufacturing a drug product requires people, proper equipment, and materials. It’s the classic three-legged stool analogy. Even with well-trained...

Automated metadata management in clinical trials

Content provided by Formedix | 01-Aug-2023 | White Paper

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in...

A Guide Through the API Drug Development Pipeline

Content provided by Lonza Small Molecules | 11-Jul-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Probiotic Powerhouses & Pioneers: Top 10 acquisition targets for growth in the APAC region

Content provided by William Reed | 21-Jun-2023 | White Paper

According to a recent report, the APAC region saw the highest growth in online sales of probiotic supplements worldwide in 2022.

Small Molecule development – getting it right

Content provided by Lonza Small Molecules | 20-Jun-2023 | Insight Guide

Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...

Validate clinical study data with Formedix CORE

Content provided by Formedix | 19-Jun-2023 | White Paper

In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules...

Strategies and tactics for success in biologics analytical testing

Content provided by Bora Pharmaceuticals | 13-Jun-2023 | White Paper

The biopharma landscape is forever changing, and with it, a demand from both patients and investors for the rapid development and progression of drug products...

State-of-the-Art Virtual Pharma Factory Tour

Content provided by METTLER TOLEDO | 09-Jun-2023 | Event Programme

Join METTLER TOLEDO’s weighing experts on a virtual tour of a state-of-the-art manufacturing facility. On the call, you'll be digitally transported...

The Right CDMO Can Unlock Faster Drug Development

Content provided by Lonza Small Molecules | 15-May-2023 | Interview

Drug development presents biotech companies with ever-changing challenges. Enabling a faster end-to-end process requires seamless flexibility and extensive...

SDTM supplemental qualifiers explained

Content provided by Formedix | 12-May-2023 | White Paper

What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....

CNS Drug Development―One Partner From Discovery to Market

Content provided by Altasciences | 02-May-2023 | White Paper

As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams...

How clinical trial software can optimize trials

Content provided by Formedix | 17-Apr-2023 | White Paper

Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations....

4 Warning Signs Your Research Site Is in Trouble

Content provided by Elligo Health Research® | 13-Apr-2023 | Insight Guide

You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...

The Complete Guide to eRegulatory and eSource

Content provided by Florence Healthcare | 01-Apr-2023 | Insight Guide

Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. This guide is designed...

Drug Solubility and the Need for Speed

Content provided by Lonza Small Molecules | 28-Mar-2023 | White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...

Are You Prepared to Meet the New FDA Guidelines?

Content provided by Elligo Health Research® | 23-Mar-2023 | Insight Guide

On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...

HEALTH IS A JOINT PROJECT READY FOR NEXT-GENERATION CDMO

Content provided by Indena | 15-Mar-2023 | White Paper

Indena offers custom development by leveraging the expertise of a specialized team devoted to designing and developing processes and analytical methods....

ODM and CDASH in CRF design

Content provided by Formedix | 10-Mar-2023 | White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

Designing an Optimal APAC Clinical Supply Chain

Content provided by Catalent | 08-Mar-2023 | Infographic

With clinical study activity increasing across the Asia-Pacific region, it is important for sponsors—both in APAC and globally—to understand the broader...

How Sponsors Reduce Chaos in Decentralized Trials

Content provided by Florence Healthcare | 08-Mar-2023 | Insight Guide

89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry...

2023 State of Clinical Trial Technology Report

Content provided by Florence Healthcare | 01-Mar-2023 | Insight Guide

Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report...

Life Cycle Extension: A Molecule’s Full Potential

Content provided by Piramal Pharma Solutions | 16-Feb-2023 | White Paper

Winning approval for a new molecular entity is just a staging post on the journey of a drug. To maximize the benefits of a therapy, drugmakers need to...

Standardizing data with NCI controlled terminology

Content provided by Formedix | 13-Feb-2023 | White Paper

The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND...

Enhance your cGMP chemical supply chain

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 09-Feb-2023 | White Paper

Supply chain issues have real, quantifiable impacts on biomanufacturers. However, the right support can make a cGMP supply chain operate seamlessly. Thermo...

Sofgen Pharmaceuticals obtains Drug Establishment License

Content provided by Sofgen Pharmaceuticals | 23-Jan-2023 | Press Release

Health Canada certifies Sofgen Pharmaceuticals in Canadian Good Manufacturing Practices (GMP) for our compliance with the Food and Drug Regulations at...

Marken Successfully Delivers Critical Stem Cell Samples to Patients

Content provided by Marken | 19-Jan-2023 | Case Study

Stem cell samples require extremely tight 24-hour turnaround times in order to be modified and processed for critical cell therapy drug development.

How a Clinical MDR Helps with Data Quality

Content provided by Formedix | 16-Jan-2023 | White Paper

This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to...

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.

Optimizing Adherence in DCTs

Content provided by PPD - Decentralized Clinical Trials | 12-Jan-2023 | White Paper

Prioritizing greater patient-centricity and creating an opportunity to reach unprecedented patient groups, decentralized and hybrid clinical trials are...