Newsletter | November 19, 2020

11.19.20 -- Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty

 
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Industry Trends In Biologics Formulations

In 2018, we saw a record-setting year for new molecular entity (NME) approvals (59) at the FDA, versus 46 approvals in 2017. Fifty-eight percent were for orphan drugs (patient populations less than 200,000 in the U.S.), with 17 biologics-based NMEs. Biosimilars are gaining traction in Europe. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.

Your Pharmaceutical Capital Equipment Project Is Cancelled: Now What?

Late-stage clinical trial failures, typically those in Phase 3 before approval, result in huge valuation hits for the product owners. Unfortunately, these cancellations also usually result in some fair amount of exposure with regard to capital equipment purchased to manufacture that product at commercial scale. Replacement or back-up projects need to take the place of these projects as part of a robust product development strategy. But what does a project manager do with this brand-new surplus equipment?

What Is The Status Of Drug Intellectual Property (IP) In Taiwan?

One of the biggest concerns about working in Asia by North American drug companies is the sanctity of their IP. Will it be copied and all the hard work, years of time, and money invested lost? This article gives insight into the Taiwan IP Office and its processes.

Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients

Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed-to-market.

Defining Feeder Accuracy For Continuous Processing

This article defines the items necessary for accurate feeding and outlines the important role that accuracy can play in the end product and process quality of any continuous operation.

Guidance For Optimization Of A Realā€Time qPCR Assay

Optimizing the formulation of reagents for your quantitative polymerase chain reaction (qPCR) assay requires careful experimental design that looks across several performance factors for each reagent formulation tested. These performance factors include assay specificity, reliability, repeatability, linearity, sensitivity, and efficiency.

Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions

When it comes to APIs and advanced intermediates, there are few pharmaceutical companies that have successfully utilized continuous manufacturing for more than a single process step. In addition, very few have been able to scale up beyond the kilogram range under cGMP conditions. In this interview with Dr. Andreas Meudt, head of exclusive synthesis for Evonik, the challenges and opportunities for the use of continuous manufacturing for APIs and intermediates are reviewed.

Business Continuity Program Helps Maintain Operations In The Face Of Crisis

Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations through a crisis situation.

Evaluating A Chemical Fume Hood For Containment Of Solids, Liquids, And Vapors Using ASHRAE 110, HAM, And ISPE Methods

Originally designed around 350 years ago to contain accidents and prevent bad odors in the laboratory, the fume hood has become a device that can routinely produce control levels of vapors down to the part-per-billion level. In this study, Flow Sciences chose to meld existing techniques centered around ASHRAE 110 with widely accepted particulate containment measurement techniques. The Flow Sciences fume hood, when used in conjunction with good lab practices, is capable of providing workers with the protection they need for applications using solids, liquids, and gases.

Manufacturing Of Sterile Aqueous Suspensions: A Primer

Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing. 

Guidance For Lab Washer Cleaning In Life Sciences

The principal concern for any scientist or technician working in the laboratory is that glassware, instruments, and equipment be free of interfering residues.

Why Choose A Commercial HPAPI Manufacturer For Your Clinical Program?

Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays.

Government Partnership Highlights Blow/Fill/Seal Advantages In Race For COVID-19 Vaccine

Continued global efforts to incorporate blow/fill/seal (BFS) into the safe and efficient delivery of lifesaving vaccines are proof the technology serves as a valuable tool in improving patient care across the world.

Nanoparticle Engineering: Revolutionizing Oral Drug Delivery

A significant obstacle to the release of new medicines is the increasing complexity of drug molecules, which contributes to increased hydrophobicity and poorer water solubility. Technologies that can enhance drug solubility and bioavailability have great potential to improve efficiency within the drug development pipeline. Nanoparticle engineering — the process of shrinking down the size of drug particles — has emerged as a promising solution to this problem.

Biosafety Considerations For Single-Use Bioreactors

Single-use bioreactors address some key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs, and optimizing cost of goods.

Engineering Approaches To Respiratory Drug Delivery: Mannitol Case Study

Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. Read our article to learn more.

Comparing Carbon Footprints Of Similar Single-Use Shippers

It is important for organizations to carefully consider the impact of their containment, packaging, and shipping decisions, especially when high volumes of transactions are involved.

Pump Life Testing Of TPE Tubing

Tubing used in welding operations is often incompatible with peristaltic pump use. We tested pump life performance by subjecting samples to continuous pumping until failure was observed.

Recommended Mixing Equipment For Liquid Supplements

In the production of ready-to-drink supplements and liquid vitamins filled into capsules, proper mixing is one of the most critical steps in achieving lot-to-lot consistency and efficacy. This bulletin describes the benefits of preparing liquid supplements in a multishaft mixer designed for bulk agitation, high-speed solids dispersion, and superior heat transfer.

Optimizing Cell Culture Media: Increase Titers With Maintained Protein Quality

When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. Here's how the process improvement can be performed reliably.

Novel High-Resolution Instrument Helps Research Institute With Latest Development

The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology studies cell ageing and regenerative engineering, precision nanomedicine, advanced materials, agriculture nanotechnology, and advanced biomanufacturing. Read more about their development of the first truly biomimetic hydrogel with help of an instrument that would be capable of being incorporated into a confocal-microscope system.

Ensuring Everything is A-OK At AKBA

With IBD and virus filtration making up a significant portion of AKBA’s business, it is critical their equipment and systems meet the strict operational needs of the manufacturing systems used by their clients.

Build Or Buy: 6 Advantages Of A Customizable GMP Environment

An alternative solution to the “build or buy” decision is the use of readily available, prequalified GMP facilities that can be fully tailored to suit individual needs and budgets.

Top Five Satisfaction Drivers For Outsourced Oral Dose Manufacturing

In Q1 2019, ISR surveyed 102 sponsors who outsource oral dosage form manufacturing to improve understanding of what influences customer satisfaction.

8 Criteria For A More Successful API Partnership
Save time and money by addressing these eight critical areas that are required for a fast and smooth API development process.
The Faster Path To Self-Administration: Moving From Prefilled Syringe To Auto-Injector

In this on-demand webinar, Ypsomed and Catalent Biologics share how to transition your product from prefilled syringe to auto-injector more quickly with an experienced partner who can anticipate equipment and process needs.

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