Newsletter | October 8, 2020

10.08.20 -- ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices

 
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Oral Solid Dose Regulatory Hurdles And How To Approach Them

In your quest to meet the regulatory requirements for your oral solids project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. In this blog experts discuss common regulatory challenges and how to approach them.

Selection Criteria For Ribbon, Vertical, Or Tumble Blenders

Among solid-solid blending systems, the three most common types are the horizontal ribbon blender, the cone screw vertical blender, and the tumble blender. Aside from level of shear or “gentleness,” other factors help determine which type of blender will work most efficiently in a certain application. Following are some things to consider when choosing your blender.

Quality Assurance And Your CDMO

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

Telltale Signs You’re With The Wrong CDMO

Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your partner isn't carrying its weight on your journey to commercialization.

Integrated Technologies To Accelerate Process Intensification For Viral Vaccine Manufacturing

With the increasing worldwide demand for viral-based vaccines (VBVs), which includes attenuated and inactivated viral vaccines, as well as viral vector vaccines to protect against the coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), faster development times are required to progress VBVs more rapidly into clinical development and then to market. To facilitate process intensification of VBVs, including SARS-CoV-2 vaccine candidates, an integrated portfolio of technologies developed by Sartorius is detailed in this article.

Container Closure Integrity Testing: Risks And Methods

An overview of integrity tests where a high sensitivity is required to prevent the risks of stability failure of highly moisture sensitive drugs or the risk of biological ingress of sterile parenteral drugs.

Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.

Advanced Cleaning Mechanisms: Cold Or Warm For Proteins?

Warm temperatures can denature some hormones and proteins, thus causing cleaning problems. A critical cleaning company gives insight on how temperature can affect enzymatic and emulsifying activity in cleaning mechanisms.

Cultural Audits: What Are They And Why Are They Essential?

The medical device industry is familiar with quality audits, but it is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

Simplifying The Supply Chain With Large-Volume Western CDMO Partners

When considering primary and secondary sourcing options, it is important to balance price and security of supply. Partnering with an integrated, Western CDMO with large-volume production capabilities for registered starting materials (RSMs), advanced intermediates, and active pharmaceutical ingredients (APIs) can provide countless advantages, including reliability and superior communication, at a competitive cost.

Drug Serialization: Key To Protecting Patients In U.S. And International Markets

Evolving track and trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise.

Increasing Productivity In Hydrophobic Interaction Chromatography

In this study, the hydrophobicity of newer generation Capto HIC resins was compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

The Definitive Guide To Particle Sizing

This paper provides an introduction to particle sizing by comparing six widely used techniques, explaining how they work, and what this means in terms of strengths and limitations. 

How To Achieve Different Release Profiles And Select Excipients For Formulation Development Of Modified Release Oral Solid Dosage Forms

Modified release formulation and manufacturing are challenging. To obtain the desired release profile — or release profiles if there are more than one active pharmaceutical ingredient (API) — a holistic approach is necessary. This paper will explain numerous considerations that enter into the planning and execution of a successful modified release oral solid dosage formulation.

Navigating Injectable Combination Device And Drug Product Regulations

Many new pharma development projects and life cycle management opportunities revolve around exploring the integration of medical devices with drug products as the industry seeks more convenient, user-focused drug delivery solutions. This webinar will introduce the topic of combination device and drug products, providing an overview of the regulatory landscape with a particular focus on injectable drugs.

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Webinar
Tuesday, October 13, 2020 | 10:00 a.m. EDT / 4:00 p.m. CEST

This webinar discusses a new process for the manufacturing of PLGA medicines at industrial scale and the use of PLA-PEG functional excipients to support the formation of nano-sized micelles for use with hydrophobic drugs, allowing increased circulation time in the bloodstream.

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