Whitepapers

In this application note, Pfizer CentreOne examines key considerations for the development and manufacturing of your unique sterile injectable.

When a large CDMO couldn’t give a mid-size pharma company the proper attention, Adare stepped in to help manufacture CTM batches and get their project to the clinic quickly.

A discussion of the FDA's guidance on nitrosamine impurities, various approaches for reducing the presence of impurities, and how Adare's unique nitrosamine mitigation process can help products achieve compliance.

In this article, gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like CDMOs is essential.

The Lonza Capsule Application Lab is uniquely focused on solving technical issues and creating new solutions related to dosage form and delivery. We work together to leverage our scientific and technical knowledge helping to improve your manufacturing process and methodology to deliver customized solutions.

This article addresses new alternatives in industrial refrigeration systems ready to comply with current and future regulations, applicable for both new and existing freeze

Understanding the impact of API solubility on the performance of a given drug product and determining ways to enhance dissolution rates is critical to ensuring your product makes it to market, into the hands of patients and clinicians, is well absorbed and provides its intended therapeutic effect. Selecting the best formulation strategy to address challenges for each API, however, can be time-consuming, costly and complex.

When it comes to viral vectors, the complexities related to varying serotypes and different sized payloads continue to impact efficiencies and timelines. Hear from Resilience experts on how innovative platform technologies can overcome these challenges and support scalable manufacturing.

Designed for advanced therapy manufacturing, the Marlborough, MA facility is the first new construction at Resilience. The site will produce, rest, and release viral vector drug substance (DS) and drug product (DP), for clinical and commercial use.

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

Various factors must be considered when it comes to developing and delivering high-quality pharmaceutical drug products or medical devices to end users. A CDMO can help ensure products maintain quality standards and are readily available as necessitated throughout development, manufacturing, and commercialization.

There are many reasons behind the success of a technology transfer. But at the center of this complexity is one critical role: project management in the tech transfer.

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

Preventing contamination during routine cleaning operations requires particle-free cleaning equipment to maintain specific airborne particle levels.

Do you face challenges when it comes to the particle quality in your granulation process? In order to produce granules with the desired properties, scale-up is crucial, in addition to looking at the process parameters. After all, the path of a drug from the laboratory to production holds many a surprise. Especially in the case of particles for inhalers, the mixing process plays a decisive role. Learn what you need to consider to produce the perfect particle. This whitepaper reveals expert know-how on the mixing details, the key figures to consider and the positive effects using the practical example of inhalants.

Technology Transfer and Commercial Manufacturing of Tablets and Capsules

Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. Unfortunately, as time passes, there is an increased risk of CMC issues becoming more complicated, time-consuming, and expensive to fix. Learn how to avoid these roadblocks by reading this white paper from Societal™ CDMO.

The relationship you build with your executive sponsor (ES) is the most critical relationship you will build with your CDMO partner and will serve as the foundation for long-term commercial success. At the core of vendor selection activities, it is vital to understand the CDMO’s flexibility and culture, models and scale of equipment, technical and analytical capabilities, regulatory support, quality system, and audit inspection history – and it is equally as vital to understand its executive sponsorship model. Learn more about why this is a vital component of your process.

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.