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Alcami Kickstarts Biologics Enterprise to Advance Treatments for Complex Medical Conditions

Durham, NC (USA) – March 19, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today launched Alcami Biologics, the organization’s new biopharmaceutical development, analytical testing, manufacturing, and packaging enterprise. Alcami Biologics will advance the commercialization of a wide range of biological products to treat complex medical conditions with unmet needs. This comes in response to increased market demand for outsourced biological drug development services.

Topics: Company News Biologics Manufacturing Analytical Testing Development Analytical Development Packaging Drug Product Parenteral Manufacturing

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: Thought Leadership Editorials Analytical Testing

The Top Five Most Asked Extractables and Leachables Questions Answered

Agency expectations are quickly evolving for the evaluation of drug product packaging and delivery systems and the surfaces used during manufacture with respect to potential leachables. Every new and generic drug product must be assessed for extractables and leachables (E&L). In this top five list, Alcami experts will address the extractables and leachables questions our experts hear most.

  1. What is the difference between an extractable and a leachable?
    Extractables are compounds that can be extracted from a packaging component, delivery system, or manufacturing surface via laboratory manipulation, such as exposure to solvents or heat. Extractables can be potential leachables. Leachables are compounds that passively migrate into the drug product over time, as a result of direct contact from the packaging system, in-use componentry, or a manufacturing surface.

Topics: Extractables & Leachables Analytical Testing Analytical Development

Agency-Accepted Testing and Filing Strategy for Elemental Impurities

The new elemental impurities regulations stress the importance of controlling all sources of elemental impurities in drug products. The regulations also impact all upcoming and current commercial drug products for human use. To comply with these regulations, it is critical to have an efficient, cost-effective, and agency-accepted approach.

Elemental impurities can contaminate or leach into a drug product from multiple sources (i.e. drug substance, excipients, water, equipment, and container closure systems), therefore, it is no longer acceptable to monitor the inlet raw materials only. A conservative risk-based approach is recommended, which should address all potential sources of elemental impurities. If it can be demonstrated that the elemental impurities present in the drug product are under control (less than the control threshold for three lots), then analysis at release is not needed. 

Topics: Regulatory Compliance Elemental Impurities Analytical Testing Analytical Development

The Top Eight Most Asked Questions about Microbial In-Use Studies

According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug product which is sterile, whether by terminal sterilization or aseptic processing. Equally important to the microbiological quality of the product at the time of product release is its microbiological quality at the time of patient administration.” This Q & A featuring microbial in-use studies with microbiological expert, Brent Harlow, will address the most common questions asked about these studies.

Topics: Analytical Testing Microbiology

ON-DEMAND WEBINAR: Submitting Samples through Alcami OnDemand™

Join Alcami for a webinar to learn more about submitting samples through Alcami OnDemand, a customer portal that provides clients unprecedented and rapid access and visualization into ongoing projects. 

Using Alcami OnDemand to submit Analytical Testing projects is a simple process that will save you time and streamline project tracking. This webinar will detail the finer points of online sample submission. We will show you how to build a sample submission project in Alcami OnDemand and walk you through the following processes:

Topics: Webinars Alcami OnDemand Analytical Testing Analytical Development

Alcami Launches New Features and Enhancements to Alcami OnDemand

Alcami OnDemand™ is a customer-focused portal giving you the power to know where your results are at all times. Alcami OnDemand (AOD) features quoting tools, project tracking, material and test reference libraries, a progressive messaging center, and central file repository. AOD provides you with the ability to build a custom sample submission quote quickly and track major milestones within your project.

Alcami’s new features and enhancements to the platform allow for a more user-friendly and intuitive system. Our mission is to continuously bring first-to-market initiatives to the pharmaceutical and biotechnology industries— further increasing our commitment to our clients and their patients. Improved features include:

Topics: Alcami OnDemand Analytical Testing

Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). MDGH utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical approval deadlines.

Topics: Company News Analytical Testing Development Analytical Development Drug Product

The Role of Full Time Equivalent (FTE) Programs

An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and biotech companies flexibility, freedom, and consistent control of outsourced laboratory needs.

Drug developers with an abundance of overflow lab testing or limited lab space and staffing are ideal candidates for what Alcami calls an Extended Workbench program. Additional support may also be critical if the US Food and Drug Administration (FDA) approves the acceleration of your drug product. The chart below is a summary of the FDA’s drug development descriptions for when a product has significant implication on a patients’ welfare (FDA, 2018).

Topics: Analytical Testing Development Analytical Development Drug Product

eBook: Guide to Stability

Stability is an integral part of the drug development process. With every stability study, it is essential to focus on the quality attributes of the product— most importantly safety.

Throughout this guidebook, Alcami scientists will discuss stability testing procedures, the  “how” and “what” of degradation in the measurement of shelf life, the importance of storage conditions, and the necessity of following a medication’s recommended guidelines.

 


Topics: Resource Center Stability Analytical Testing