News & Analysis on Clinical Trial Services & Contract Research And Development
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 be formed as by-products of the synthetic process
New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small molecules and systemic indications.
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.
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...
Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.
Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated with this process can be challenging. Beyond procurement challenges, raw materials need to...
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...
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.
Indena is well known in the space of naturally derived molecules, with a know-how developed over its one hundred year history. At the same time, the company has significantly expanded its technological offer beyond that, now encompassing fermentation and...
Signant’s eConsent solution helped a sponsor manage the consenting process complexities in their pediatric attention deficit hyperactivity disorder (ADHD) study located in Japan. This blinded case study explores how leveraging technology addresses the...
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...
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.
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.
Indena’s Custom Development & Manufacturing Organization services offers a full range of manufacturing capabilities for pharmaceutical ingredients. Such services include the extraction, isolation and purification of natural derivatives and the process R&D...
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...
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.
The Piramal Pharma Solutions facility in Sellersville, PA USA is a fully integrated site that offers product and process development, clinical supply and commercial manufacturing and packaging of solid oral dosage forms, liquids, creams and ointments....
The Piramal Pharma Solutions facility in Lexington, KY USA is a fully integrated site which offers analytical, formulation development, and manufacturing services with an emphasis on clinical trial to commercial-scale manufacturing of sterile liquid and...
The Piramal Pharma Solutions facility in Riverview, MI, USA can support your Drug Substance (API) needs. The site has extensive experience in safely delivering high potency APIs HPAPIs) and has advanced several HPAPIs from early development to commercial...
The Piramal Pharma Solutions facility in Morpeth, UK offers Active Pharmaceutical Ingredients (APIs) and oral solid drug product development, clinical supply, commercial manufacturing and packaging services to both innovators and generic pharmaceutical...
The Piramal Pharma Solutions site in Grangemouth, UK offers development, clinical & commercial scale manufacture of bio-conjugates including Antibody Drug Conjugates (ADCs). Since 2012, the site provides full process & analytical development services to...
The Piramal Pharma Solutions facility in Aurora Canada offers development, clinical and commercial GMP manufacturing of Active Pharmaceutical Ingredients (APIs) for complex pharmaceutical NCEs. It is a US FDA, Health Canada and PMDA inspected site.
Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance & drug product, Piramal Pharma Solutions offers unique expertise in world-class integrated solutions...
The COVID-19 pandemic has brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links & re-igniting discussions around the value of reshoring production. The U.S. FDA reports 72% of facilities manufacturing...
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...
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...
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...
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...
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 free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies globally. It covers data reported for the 2018 fiscal year, as well as historical data to view long term...
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...
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,...
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...
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...
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...
As a global contract manufacturing leader in prefilled syringe fill-finish, BioPharma Solutions offers clinical through high-volume commercial sterile manufacturing. Redundant like-in-kind filling...
Chazy, New York is located only six miles from the Canadian Border in Upstate New York. It is only ten minutes North of Plattsburgh, one hour south of Montreal, Quebec, Canada, and one hour west...
Pfizer CentreOne™ is a global contract manufacturer that focuses on API synthesis and sterile injectables fill-finish. For 40+ years, we've manufactured complex compounds for our...
The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness of the validated analytical method. In...
Pfizer CentreOne™ is a global CMO that focuses on API synthesis and sterile injectables fill-finish. For 40+ years, we’ve manufactured complex compounds for our biopharmaceutical partners. Our...
Billions of patients worldwide benefit from a diverse range of medical devices. The global medical device market in 2011 was approximately $300 billion and is predicted to grow by 4% per year to...
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...