Newsletter | January 16, 2024

01.16.24 -- Best Practices For Preformulation In Drug Development

FEATURED EDITORIAL

Best Practices For Preformulation In Drug Development

Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.

INDUSTRY INSIGHTS

Scale Up Manufacturing With Engineering Biology

Could an “engineering biology” approach be the solution for biopharmaceutical leaders struggling to scale-up and meet the growing demand for advanced therapeutics?

Planning Audit-Ready Production Automation

Learn how to achieve audit readiness while planning the automation infrastructure for regulated batch processes. Explore data compliance needs for audits and technologies that support them.

Improving Medical Device Sustainability

Product design, production methods, and supply chains can be leveraged to positively impact sustainability through effective planning.

Strategies And Emerging Technologies For mAb Capture

Find out about opportunities with the introduction of high-capacity protein A resins, how and when multicolumn chromatography is beneficial, and how emerging technologies can address bottlenecks.

Formulation Development For Injectables

A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Discover how the right formulation approach can enhance drug delivery and improve patient outcomes.

Mopping Floor Surfaces: Coverage, Buckets, And Validation

A clear understanding of mopping best practices is needed to make informed decisions that improve cleanroom maintenance while controlling costs. Learn about mopping coverage, systems, and validation.

Identify Lead Solid Form Early To Reduce Timelines And Downstream Costs

Devoting early-phase resources for solid form understanding and screening during a drug’s development life cycle is critical, as doing so can help save time and resources on the path to market.

Four Leading Injectable Manufacturers Automate Tray Count Operations

Learn about the solutions that were developed to meet four manufacturers' constantly changing product mixes, improving manufacturing operations by reducing risk, improving compliance, and more.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

A cleanroom facility that remains safe for your workers — and where the therapeutics they produce remain safe for patients — can ease your compliance concerns.

Bilayer Tablet Manufacturing: An Overview

Bilayer tablets offer a number of benefits for patient care; understanding the challenges that accompany their formulation is key to enabling their successful commercialization.

Improved Chlorhexidine Carryover Performance Using A Modern System

Carryover performance was assessed across HPLC systems using a scaled method based on the USP monograph for chlorhexidine hydrochloride organic impurities. Explore results and mitigation strategies.

Why Perform A Product D-Value Study?

Learn about biological indicators, D-value, and steam sterilization for liquid loads.

SOLUTIONS

Powerful Performance In A Base Medium

Environmental Monitoring Solutions For The Pharmaceutical Industry

An Advanced, Efficient, And Sustainable Cold Chain Solution

Aseptic Filling Systems For Biopharmaceutical Manufacturing

Flexible Label Inspection Solution For Oriented Products

Unused 2,000 Liter Single-Use Bioreactor

Small Batch Aseptic Filling Systems For Powders And Liquids

PBPK Predictive Modeling Services

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