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Beyond the Bench: A Century of Experience

The second edition of the Beyond the Bench series features three of Alcami’s longest-tenured employees. Meg, Karen, and Sally have worked at Alcami and its legacy companies over a century, collectively. These women share in common not only a long history with the company, but they are all also great at sharing their knowledge. Please meet Meg, Karen, and Sally. 

Alcami applauds your loyalty and dedication. You are all valued, expert contributors at your sites! Please introduce yourselves and paint a picture of your start with the company .

Topics: Thought Leadership Alcami Voices

Elevate Product Stewardship and Exceed Your Sustainability Goals

At Alcami, the health and safety of our workers is not taken lightly. Rooted in the foundation of The Alcami Way, safety comes first and is one of our non-negotiables. As a trusted partner and supplier, we can help you achieve your product stewardship and sustainability goals by providing a safe and healthy working environment for our employees.

The globalization of the pharmaceutical industry has led to supply chains that can be extremely complex and difficult to manage. In some cases, the health and safety practices can be vastly different than the current expectations from the public and shareholders. As sustainability intelligence increases, transformative operational strategies are needed to optimize your supply chains and meet your goals.

Topics: Thought Leadership EH&S

Understanding Pharmaceutical Packaging

For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are critical to the success of a product. The best formulated product in the world can fail if it is contained in an inappropriate package. So how does one decide which packaging to use for a product?

First and foremost, the package has to protect the product from damage or degradation. Different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered products may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. Alcami works with clients to customize the best package configuration for product protection.

Topics: Thought Leadership Serialization Oral Solid Dose Packaging Pharmaceutical Packaging

Panel Discussion: Oral Solid Dosage Manufacturing Process 

Alcami recently contributed to Pharma Horizon's first Panel Discussion of 2018, dedicated to the Oral Solid Dosage (OSD) Manufacturing Process. 

The topics discussed include main challenges that manufactures of OSD forms have to face, such as quality, safety and productivity, as well as technical advancements, production management, operational excellence aspects, tech transfer, and packaging operations.

Topics: Thought Leadership Manufacturing Editorials Oral Solid Dose

Editorial: Driving Change in the Pharma Industry and Biotech One Relationship at a Time

As published in Pharma's Almanac Q1 2018.

Although small and medium-sized pharma and biotech companies are driving the growth of the industry, they often don’t receive the attention and assistance that are essential to their success. Changing the industry’s mindset is critical. Alcami is establishing many different relationships intended to facilitate and accelerate just that.

Topics: Thought Leadership Editorials

Editorial: Is industry ready for the serialisation shake-up?

Alcami recently authored an article featured in Chemistry World titled "Is industry ready for the serialisation shake-up?"

The regulation few outside of pharma have heard about

Within the next year, pharmaceutical industries in the US and EU will undergo what could be considered one of the greatest regulatory shake-ups in the modern era. Government regulation – coming into force in late 2018 and early 2019 for the US and EU respectively – dictates that all pharmaceuticals be subject to track-and-trace capabilities, also known as serialisation.

Topics: Thought Leadership Serialization Editorials

Editorial: Transparent and Timely Testing

Alcami recently authored an article featured in Speciality Chemicals Magazine titled "Transparent and Timely Testing." 

Analytical testing is a pre-requisite for the majority of products that use specialty chemicals, but it can be time-consuming and complex. CDMO Alcami outlines the advantages of using a CDMO and introduces its Alcami OnDemand program management portal, which offers transparency and quick turnaround times.

Topics: Thought Leadership Alcami OnDemand Editorials Analytical Testing

Serialization CDMO Checklist

Given that serialization execution is new to many in the industry, what should drug developers look for when reviewing a new contract development and manufacturing organization (CDMO) that will be manufacturing serialized product or when approaching the project with existing CDMOs?

Topics: Thought Leadership Regulatory Compliance Serialization

Editorial: Stability Testing Ensures Proper Packaging for Drug Storage

Alcami recently contributed to an article featured in BioPharm International titled "Stability Testing Ensures Proper Packaging for Drug Storage." 

Stability testing is essential for maintaining the integrity and quality of biopharmaceuticals and for assessing an accurate shelf-life. It is an important aspect of quality control and is an important step in evaluating product safety and efficacy. It is also important for examining how critical quality attributes (CQAs) of a drug substance vary with time under different environmental factors.

Topics: Thought Leadership Stability Editorials

Editorial: Tackling the Opioid Crisis with Abuse-Deterrent Formulations

Alcami recently contributed to an article featured in Pharmaceutical Technology titled "Tackling the Opioid Crisis with Abuse-Deterrent Formulations." 

The United States is facing an opioid crisis. FDA has expressed concern about the growing epidemic of opioid abuse, dependence, and overdose, and part of its action plan includes a call to pharmaceutical manufacturers to develop opioid formulations with abuse-deterrent properties (1). As a result, there is increasing interest in the development of abuse-deterrent formulations as the technologies to prevent abuse among patients and recreational abusers continue to advance rapidly. 

Topics: Thought Leadership Abuse-Deterrence Editorials