Whitepapers

To help navigate supply chain risks and avoid drug shortages, PCI have created a quick reference guide to recent draft FDA Guidelines: Risk Management Plans to Mitigate the Potential for Drug Shortages.

A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. This eBook provides insights on key approaches and considerations for preparing your program for long-term success.

Advances in silico and experimental techniques mean that APIs and prototype formulations can be thoroughly characterised using multiple material sparing assays, allowing the most promising formulation candidates to move on to in vivo studies.

Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound is processed in the body and improve the fate of many of these candidates, improving pharmacokinetic profiles and pharmacodynamic responses. Two Catalent experts discuss the ways companies can address issues with low bioavailability, and the benefits of enlisting an experienced drug development partner.

API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success when moving from preclinical development to early phase clinical trials.

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.

Developers anxious to move their small molecule to Phase I may not have the time or resources to fully characterize the druggability of their candidate. Issues that could delay or even derail the program may appear in later clinical studies. Catalent has the resources to characterize lead molecules and develop the best pathway to bring them to Phase I studies and beyond.

In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with orphan drugs will be included, with insights on how drug sponsors of all sizes work with contract development and manufacturing organizations (CDMOs) to achieve their goals.

The development of orally administered small molecules is becoming more challenging as an increasing number of molecules in pipelines have poor aqueous solubility and bioavailability.

Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules. For selecting the most suitable formulation technologies in early-phase development, formulation scientists regard efficacy, safety, bioavailability and stability as their top priorities. However, an early-phase formulation strategy should also consider scale-up and manufacturing challenges that may arise later in development. If bioavailability and manufacturing challenges are not addressed in early development, the cost and overall timeline of the project may be negatively impacted. Therefore, developing a bioavailable formulation that is easy to scale-up with superior dose uniformity is imperative for a product’s success.

Critical considerations for deploying smart, fast, and flexible Life Sciences facilities

Tailored manufacturing capabilities are critical in a CDMO. But, when you’re sprinting to market with a niche product, a partner who can also source your raw materials and de-risk your regulatory pathway is everything. With the right partner, every point along the development and manufacturing value chain journey becomes accelerated.

Through advanced technology, deep industry knowledge and an unwaveringly collaborative approach, our proven capabilities help life sciences companies succeed in a highly competitive and complex marketplace from targeted biologics to cybersecurity.

Partner Smart with End-to-End CDMO. What if you could rely on one partner to source APIs, formulate and develop drug products, and manufacture at clinical and commercial scale? Rather than too many links in your supply chain, an end-to-end CDMO reduces layers of administration, gaps in knowledge, time, cost, and risk.

Cybersecurity with Clarity and Rockwell Automation

Get ahead of cyber-attacks by keeping pace with the speed of IIoT innovation

Optimizing API Procurement. Supply chain woes existed long before the pandemic, and not many scientists want to spend time sourcing ingredients. There is a way to ensure you get the right active pharmaceutical ingredients, at the right cost, with the right plan to scale: partnering with an API procurement and supply chain specialist.

WuXi Sta outlines clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.

Review testing requirements for lab balances in the pharmaceutical industry described in the relevant pharmacopoeias and the associated certificates offered by Sartorius.

This technical brief will start by outlining the importance of cross-coupling catalysts in the industry. It will then weigh up the benefits of existing in situ and pre-formed catalysts. The remainder of the technical brief introduces Johnson Matthey’s DyadPalladateTM pre-catalysts as a cost-effective and greener alternative to traditional in situ systems.

Peptide modification via salts is a way to change properties of the API to make it more advantageous to the desired release profile.

A long-acting injectable improves the patient’s experience by only requiring a once weekly, or monthly injection as opposed to a daily dosing regimen. The gel depot formulation is simple to manufacture, and easy to tune to the desired release duration and dose.

The recently introduced NanoFlowSizer instrument employing novel ‘Spatially Resolved Dynamic Light Scattering’ (SR-DLS) provides a breakthrough in inline nanoparticle sizing

We demonstrate the wide range of customized products and services that Actylis offers its biopharma customers.

We showcase Actylis, what the company stands for and how we serve our broad-ranging customer base globally.

We look at the importance of finding suppliers able to develop and customise Process Intermediates to meet the rapidly-changing expectations of modern finished drug manufacturers, and the economic & logistic benefits of outsourcing Buffer manufacturing, especially with the rise of cell & gene therapy products.

In this whitepaper we explore the role of GMP-grade Phenylmethylsulfonyl fluoride and other protease inhibitors in biopharmaceutical manufacturing, and we outline how Actylis’ high-purity and refined PMSF helps finished drug manufacturers to meet increasingly rigorous regulatory requirements.

We provide a list of readily available high-quality biopharma ingredients used for in vitro diagnostics, vaccines, cell cultures and preservatives that we keep on hand to service our biopharma customers. All these raw materials have a very short lead time to suit your rapidly-changing manufacturing needs.