Whitepapers

Do you want to develop an oral controlled release (OCR) product? If so, you’ll quickly realize there are a lot of questions to answer. What do you want the final dosage form to do? What formulation and process approach are you going to use? What traps and roadblocks might you encounter? Understanding the options and their ramifications is the first step toward devising a plan.

An overview of Societal CDMO’s capabilities within the pharmaceutical space. Societal™ CDMO is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules

Central to a successful technology transfer is effective project management. This white paper discusses the role of project management at Jubilant HollisterStier in creating and executing transfer plans and the innovative solutions developed for the transfer of five COVID-19 vaccine and therapeutic fill finish manufacturing projects.

Vetting a CMO for sterile injectable fill finish means more than capacity and equipment. This white paper from Jubilant HollisterStier discusses the range of factors to consider when outsourcing manufacturing for aseptically filled and terminally sterilized products.

Specialization in ophthalmic manufacturing, demonstrated by investment in equipment, technical project management, quality systems, and regulatory compliance, ensures a safe, effective eyecare drug product. Learn what to look for in a contract manufacturing organization for ophthalmic fill finish, and how Jubilant HollisterStier can validate and scale highly efficient, replicable processes.

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. Learn more about creating a safe, efficient and scalable drug development program with HPAPIs in this eBook.

Experic talks about how biopharmaceutical companies can leverage CDMO collaborations to mitigate risks and maximize the benefits of key drug development decisions.

Find out how the NanoFlowSizer’s THALIA system is capable of measuring particle size in continuous liposome manufacturing with low lipid concentrations, below 3 mg/mL.

A convenient checklist from the experts at Experic to jump-start your planning so supply challenges won’t hinder your progress! Download the checklist today and take advantage of Experic's expert tips to optimize your clinical trial supply planning.

By partnering with a specialized CDMO, a company can leverage its expertise, state-of-the-art facilities, and streamlined processes through the entire drug development journey.

A common obstacle life sciences organizations face during clinical trials is obtaining the right patients and promoting consistent engagement. High-quality data and technology can be used to streamline clinical trials and enable omnichannel experiences.

Modern mathematical and computerized modelling tools can improve scale-up and efficiency of continuous manufacturing of oral solid dosage drugs.

This whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables

Biotech, BioPharma’s, CDMOs, CROs who are investigating promising nucleic acid-based drug candidates like vaccines, mAbs, and other biologics & biosimilars must go through stringent quality control checks for their molecular entities to ensure safety & efficacy of their drug candidates. Explore the best quality control workflows using QualTrak qPCR ecosystems. Learn more inside this eBook about the benefits of:

Implementing a proper contamination control strategy (CCS) helps ensure product quality and patient safety. Additionally, it is a core element of good manufacturing practices.

Analytical Method Development for Synthetic Peptide Purity and Impurities Content by UHPLC - Illustrated Case Study

KBI Biopharma has created a platform E.coli resulting in a PURE, efficient platform expression strain - PUREcoli™ - to reduce impurities and reach higher titers.

This executive summary highlights strategies that can be used to maximize long-acting parenteral formulations using nanoparticles, microspheres and in-situ forming gels.

A company focused on the treatment of advanced solid tumors, partnered with Catalent for the development, clinical trial supply and scale-up of a spray-drying program.

Discover how to use enteric polymer coatings effectively for controlled drug delivery in oral medications to enhance your drug formulations.

In pursuit of increased competitiveness and bottom-line impact, pharmaceutical manufacturers face increasing pressure to fast-track technological innovation while maintaining regulatory compliance. This e-book explores how Artificial Intelligence (AI) can unlock new levels of insights into what is causing variation in processes that can wreak havoc on your drug manufacturing performance. Learn how to use AI so you can improve your manufacturing operations in GxP environments that are capable of delivering real returns on Pharma 4.0 technology initiatives.

How to Craft a Successful Orphan Drug Designation

Oligonucleotides are a class of biotherapeutics presenting complex challenges in the development and commercialization of gene therapies. Download our paper and learn how to move your project forward.

Speed is a critical factor in early-stage development. Solid state studies within an integrated CMC platform can support formulation development, accelerate timelines to Phase I clinical studies and increase the likelihood of successful clinical trial results.

Process equipment used in the healthcare and pharmaceutical industries follow rigid specifications for accuracy, consistency and cleanliness.

This case study shares why a leading biotech company reached out to Aizon to identify how artificial intelligence (AI) could be used to further optimize yield. The team was able to analyze five years of historical batch data to discover a direct correlation between hold up volume and time between process operations as well as generating millions of additional recovered revenue.