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
Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract
Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be confusing.
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...
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 to market.
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 addressing the many challenges for biotechs, this eBook is your guide to navigating the drug development...
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 continue trying to improve the product life cycle and reach more patients after winning first approval.
Operational Excellence (OE) is a key element of organizational leadership and intelligence. For a CDMO operating in the pharmaceutical industry, OE focuses on serving patients and customers efficiently in aspects of safety, quality, delivery and cost.
In the present study, the performance of PROSOLV® EASYtab SP was tested in four DC formulations with different model APIs.
Developing formulations for pediatric patients poses unique challenges. The specific needs of children, which vary by age, mean the task goes beyond scaling down the dose of the adult formulation.
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...
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...
Lactium® gives you the chance to better meet your pet’s needs for a more harmonious life together. Lactium® acts on the brain and has no side-effects, in terms of sedation or addiction. Natural hydrolyzed milk protein, it has no toxic effect on the body,...
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...
Lactium® is a milk protein hydrolysate which contains a bioactive decapeptide with soothing properties called α-casozepine. It decreases anxiety-related symptoms and helps consumers better manage their emotional state ( induced by occasional or everyday...
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...
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 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...
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...