Newsletter | October 15, 2020

10.15.20 -- Comparing The Top 10 Pharma Inspection Findings From FDA MHRA Russia's Ministry Of Health

 
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Keeping Pace With Increasing Biopharmaceutical Manufacturing Demand

Today’s biologics pipeline is healthy, but forecasts indicate growth so robust the industry risks being ill-equipped to meet demand. Will contract manufacturers rise to the demand challenge?

How To Maximize The Performance And Life Of Your Centrifuge

Centrifuge technology has evolved, and while advanced features offer improved functionality, proper use and care on a daily basis are critical. It maximizes performance and extends the equipment life.

An Introduction To High Containment For Lyophilization Processes

Almost every pharmaceutical and biopharma lab in the world uses lyophilization in their daily processes. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredients, protein, collagen, peptide, oligonucleotides, chemical APIs, enzymes, and monoclonal antibodies (mAbs). This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.

Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy

Implementing automated technologies and robotics could be the solution 503B compounding pharmacies need to overcome growing issues with sterility and data integrity.

Identifying Abrasive Wear Risks In Tableting Tooling For Nutraceutical Products

Tablet presses are used to manufacture a variety of products, such as pharmaceuticals, nutraceuticals, veterinarian products, confectionary, and industrial tablets. Each industry faces unique challenges due to the properties inherent to any particular formulation. A variety of steel types/coatings, tool design modifications/options, and tablet design recommendations can work together to increase tool life and improve tablet quality.

Serialization And Aggregation Requirements In Russia

Russian president Vladimir Putin signed Federal Law No. 488-FZ, which deals with the amendments to the “Principles of State Regulation of Trading Activities in the Russian Federation.” 

Overcoming Analytical Compliance Challenges

Given the need for accurate analyses to ensure the quality, safety, and efficacy of drug products that reach the marketplace, analytical method development and validation compliance requirements are both extensive and stringent. CDMOs that implement strategies for facilitating analytical method development and validation in anticipating evolving compliance requirements help their customers reach the market sooner while leveraging a more secure supply chain.

Optimize Your Critical Cleaning Process And Ensure Results

Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.

Characterization Of Protective Face Masks

Face masks that cover the wearer’s mouth and nose, such as surgical masks, are intended to prevent large particles from being expelled by the wearer into the environment and most have a fluid-resistant outward-facing layer to protect the wearer against splashes and droplets. This report focusses on the physical characterization of a three-layer pleated mask and a molded cup mask.

The Criticality Of API CDMO Selection: Insights From A Client

Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them.

The Importance Of Package Integrity To Shelf Life Of Products
Pharma Tech Industries (PTI), a contract manufacturer and packer of pharmaceuticals, medical devices, and personal care products, is focused on exceeding customers’ expectations. They rely on X-ray, metal detection systems, and checkweighers to consistently achieve their high quality standards.
How To Select The Best Courier Around The Globe

As a leading biotechnology company's pipeline and global presence continued to grow, management of the supply chain presented challenges. Learn how data-driven decisions allowed them to realize cost and performance improvements across the supply chain.

EU Orphan Drug Launch

Although rare diseases are characterized by low prevalence individually, the total number of people affected by rare diseases in the EU is estimated at between 27 and 36 million.

A Strategy To Remove Formulation Development From The Critical Path During Biologics Development

Biopharmaceuticals tend to be highly unstable. Therefore, as the product development program progresses to the Phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. During this Q&A, Dr. Jun Lu, director, analytical development, discusses how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development.

CCI Testing To Develop ASTM Standard No. F3287-17

The poster explains a mass extraction technology, especially suitable for pharmaceutical container closure integrity testing (CCIT) applications, acknowledged by an ASTM standard.

4 Critical Processes Impacting Cost Of Goods For Gene Therapy

Many gene therapies rely on plasmids and viral vectors. There is an urgent need to drive down the costs of these critical components. Learn about the critical steps that impact cost and process innovations for viral vector manufacturing.

Top Five Oral Dosage Forms By Portfolio Composition

The top five oral dosage forms account for more than half of the products in oral dose portfolios and are: tablets, capsules, controlled release tablets, controlled release capsules, and immediate release tablets.

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Tuesday, October 20, 2020 | 10:00 a.m. EDT / 4:00 p.m. CEST

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Tuesday, October 20, 2020 | 8:00 a.m. CEST; 10:00 a.m. EDT

Technical improvements related to cryogenic electron microscopy (cryo-EM) have triggered a revolution in structural biology and made single-particle cryo-EM the dominant discipline for determining structures. Cryo-EM has opened new opportunities to determine large and complex molecules but has also introduced new challenges for the purification of samples.

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