NEWS & EVENTS

Editorial: An Interview with Alcami Parenteral Experts

Sterile Fill Line 2Alcami parenteral experts recently contributed to an article in Pharmaceutical Outsourcing titled, "An Interview with Alcami."

As new parenteral products are introduced into the market, what are some of the challenges parenteral manufacturers have faced, and how do they solve these challenges?

If current trends hold, it is expected that new parenteral products will be increasingly complex, requiring nonstandard manufacturing technologies subjected to higher standards of regulatory scrutiny and market expectations. With the emphasis on precision medicine— an emerging approach of disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person— there will be a greater number of biologic drugs, multidrug combination products, drug device combinations, and targeted drug delivery systems introduced to the market. Parenteral manufacturing of these complex drug products will require special equipment, technologies, and control strategies. It will also require highly skilled process engineers, manufacturing operators, and quality assurance personnel. Furthermore, a greater number of new molecules will be highly potent requiring special containment facility, environmental controls, and operator training that is not commonly available in many of today’s manufacturing facilities.

Topics: Editorials Drug Product Formulations Parenteral Manufacturing

Editorial: Oral Solids Endure & Evolve

Alcami recently contributed to an article in Contract Pharma titled "Oral Solids Endure & Evolve."

Contract Pharma talks with several contract service providers about the state of the oral solid dose development and manufacturing market.

The oral solid dose (OSD) development through manufacturing pipeline of products is expanding at a robust rate—even while industry watches the investment, interest and demand for biologics and biosimilars growing rapidly. There are several reasons OSDs continue to be the most popular dosage form for getting drugs to patients. In addition to being cost effective and relatively easy to make compared to their large molecule counterparts, they are most importantly, patient friendly, especially among the pediatric and geriatric populations.

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Topics: Editorials Oral Solid Dose

Editorial: Outsourcing Analytical Testing - The Gateway to Drug Manufacturing

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Outsourcing Analytical Testing: The Gateway to Drug Manufacturing."

Alcami: Customizing Programs to Meet Accelerated Product Timelines

Alcami is a CDMO that offers fully integrated, comprehensive analytical testing to support technologies for every stage of development. Its laboratory services platform is comprised of analytical testing and development services for small molecule and biologics drug products, as well as specialized offerings such as elemental impurities, abuse deterrence, and extractables and leachables. In addition, formulations development scientists address challenges related to new chemical entities.

Topics: Editorials Analytical Testing

Editorial: A Practical Approach to Extractables & Leachables

Alcami recently authored an article featured in Drug Development & Delivery titled "A Practical Approach to Extractables & Leachables." 

INTRODUCTION

The study of extractables and leachables (E&L) has been evolving for many years. As pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it. Many of the case studies that initiated interest in extractables and leachables are based on primary packaging. In some cases, the secondary or tertiary packaging were identified as sources of leachables. As a result, the primary emphasis of extractables screens has been on the packaging systems. The approach to these screens is well established. The first iterations of regulatory guidance addressed the common packaging materials in the United States Pharmacopeia (USP) chapter <661>, which relied heavily on physiochemical testing to characterize the material of construction but did not directly address extractables testing of the final packaging materials in detail. With advancements in the manufacture of plastics and increasing variety of base polymers used for packaging systems, it became evident that more specific guidelines are needed.

Topics: Extractables & Leachables Editorials

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: Editorials Oral Solid Dose

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: 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: 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: Regulatory Compliance Serialization Editorials

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: 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: Abuse-Deterrence Editorials