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Drug delivery, formulation
Reliability, scale, and security of supply
Univar Solutions Pharmaceutical Ingredients is proud to offer one of the most expansive portfolios of 15,000+ products, including high-purity solvents, excipients, APIs, and bioprocessing ingredients combined with innovative and custom supply chain solutions
Increasing the Bioavailability of Oncology Drugs
Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract
Let your Senses Guide you into the world of Art & Science: Meet with Funtrition & Sofgen during Supply Side West 2023
Procaps Group, a leading integrated LatAm healthcare and pharmaceutical services company,
Addressing Challenges with Clinical In-Use Testing
Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes the key elements to support superior product quality and patient safety.
PBPK modeling that saves you time and money
Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug development projects meet tight timelines and budget objectives.
In vitro evaluation of the gastrointestinal delivery of acid-sensitive pancrelipase in a next generation enteric capsule using an exocrine pancreatic insufficiency disease model
International Journal of Pharmceutics: In Vitro: The dissolution characteristics of five capsules (Next Generation Enteric [NGE], Vcaps® Enteric [VCE], VCE DUOCAP® [VCE/VCE] system, Hard Gelatin Capsule [HGC] as negative control, and Creon® 10,000 U as...
Manufacturing Drugs with Highly Potent APIs
In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs), including: a review of the relevant guidance HPAPI classification systems safety processes...
ReciBioPharm - An optimized Plasmid DNA platform to accelerate the path to clinic and commercialization
Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity Customizing the downstream process to address the different needs from supercoil plasmid and linear isoform A platform approach with integrated...
How enhancing equipment reliability supports quality, efficiency, and operational excellence
Successfully manufacturing a drug product requires people, proper equipment, and materials. It’s the classic three-legged stool analogy. Even with well-trained staff and high-quality materials, if the equipment does not function as expected, or is not...
Drug Solubility and the Need for Speed
A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways of improving solubility if the product is to succeed. This also has to be done as quickly and...
2023 State of Clinical Trial Technology Report
Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report includes insights from 450 sponsors, CROs, and sites, who shared what technology they’re investing in,...
Tackling Early Phase Development with First-In-Human Study Solutions
Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process. At Altasciences, we simplify the journey for you, and deliver a stress-free...
The Complexities of Ophthalmic Drug Development
Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory knowledge and scientific expertise in this therapeutic area. Partnering with a single integrated...
Formulation Effects on Tablet Surface Properties and Film Coating Adhesion
The aim of this study was to investigate the influence of different commonly applied lubricants and disintegrants on tablet surface and film coating adhesion. In addition, a commercially available co-processed excipient for direct compression (PROSOLV®...
Flexible Filling Solution for CMOs
Achieving flexibility requires modularity of technologies. CMOs and CDMOs aspire to be flexible for multiple applications. Efficient automated filling solutions like RoSS.FILL have answers to the myriad of options available and are easy to plug and...
Nanomilling for Better Solubility and Bioavailability
40% of marketed drugs and 90% of active pharmaceutical ingredients (APIs) are poorly water-soluble. Nanomilling is a proven technique that can overcome solubility challenges and ensure your molecules are developed successfully into life-saving therapies.
How Formulation Development Affects Manufacturing
Due to advances in technology and increased development of parenteral drugs, one of the fastest-growing choices for drug delivery in the pharmaceutical industry is the prefilled syringe (PFS).
Maximizing Drug Formulation for First-In-Human Trials
The manufacture of a drug product for clinical trials is of critical importance. The formulation, manufacturing, and assessment of a drug candidate during first-in-human (FIH) trials can be contributing factors in whether the drug safely provides the...
Eastern & Western Manufacturing Solutions
The best manufacturing site for a product can change throughout the life cycle. When bringing new drugs to market, biopharma companies may benefit from keeping production in the US to localize the supply chain and ensure the speed of delivery.
Flexibility and capability in pre-filled syringes
Pre-filled syringes have risen in popularity in recent years but the pandemic’s impact on drug development, manufacturing and patient care has created new fertile ground for acceleration of adoption that shows no sign of stopping.
Overcoming Solubility Challenges with Liquid-Filled Capsules
Poorly soluble molecules comprise more than 70% of the small molecule products entering the drug development pipeline today, and are difficult to formulate as tablets. Formulation scientists have found that two-piece, liquid-filled, hard-shell capsules...
A Better Approach, for Better Pain Trials
Pain studies face unique challenges. For one, pain severity can only be truly assessed by the patients themselves. The controlled substances that are often used as experimental treatments in these studies bring stricter drug accountability requirements....
Bioavailability Enhancement Techniques to Improve Patients' Lives
Oral bioavailability is a constant challenge for developers of new chemical entities. Low solubility and permeability often reduce the fraction of an orally administered drug absorbed in the bloodstream.
Transforming Clinical Development
The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical, medical device and diagnostics manufactures to identify failures early, in order to minimize costs,...
Q&A: Effective Drug Product Process Development
In this Q&A, a Catalent Biologics expert shares his expertise with drug product process development challenges, risks and how to mitigate them, the difference between innovator and biosimilar drug product process development, and what to expect from the...
Seasonal Vaccine Manufacturing
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting from annual strain selection. The timeline for development of a seasonal influenza vaccine...
Formulation and development strategies for amorphous solid dispersions
A large and increasing fraction of orally administered small molecules in pharma company pipelines have poor oral absorption due to low aqueous solubility or dissolution rate. To address this trend, evaluating formulation approaches for increasing oral...
Accelerated development of first-in-human programs. Lonza’s SimpliFiH® Solutions
The presented program is laid out as integrated Drug Substance, Particle Engineering and Drug Product services, enabling drug substance and drug product delivery in 40 weeks or less from the start of the project to the readiness, drug substance...
Flow Cytometry Services
We are an established leader in flow cytometry services for clinical trials. Our technologies and solutions meet the growing global demand for enhanced discovery capabilities, and the subsequent complex and comprehensive data sets required for drug...
Outsourcing Analytical Testing for Biologics - A CRO's Perspective
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...
How to Avoid Surprises in Small-Molecule Drug Development Programs
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21...
Validating The Simoa Technology
Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and...
The Truth about Physician Referrals and Clinical Trials
Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their patients to the investigator. BBK Worldwide’s Study Voices survey challenges the myth, invoking a...
Stability Testing As a Quality Control Measure
Stability testing is, in essence, a quality control process and is there¬fore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as...
Survey Report: State of the global pharmaceutical contract services industry 2018
In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of pharmaceutical professionals, including sponsor companies as well as contract research, development,...
Marken Delivers Compassionate Use Dose of Emergency Medication to Critical Pediatric Patient
A desperate mother in Germany urged her team of doctors to reach out to a Marken client on behalf of her two year old girl. The child was battling leukemia and had exhausted all currently available treatment options. The client manufactures a drug not...
Lyophilization Scale-Up and Tech Transfer
There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. There can, for example, be differences in design of lyophilizers at...
Process Development for Lyophilized Products
Baxter approaches formulation and process development with the intention of identifying the failure points for the product. Knowing where the product fails enables the development scientist to design a formulation and process with meaningful ranges...
UPLC Analysis of Methoxy & 2-Hydroxypropoxy in Hypromellose
Because of its use in the pharmaceutical and food industries, the USP has established standards relating to the amount of methoxyl and 2-hydroxypropoxyl substitutions in hypromellose. The USP...
Article on Viral Clearance for Biopharmaceuticals
Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the...
Optimize Your Sponsor-CRO Relationship
Within the pharmaceutical industry, there are six dominant methods used to model outsourcing strategy. This white paper details how a hybrid strategy can help sponsors to achieve cost savings and...
The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...