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White Paper: Structural Characterization of Biologics Using High-Resolution Mass Spectrometry

Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually. To keep up with this impressive growth rate, many contract development and manufacturing organizations (CDMOs) are making strategic investments in equipment and expertise to support analytical development and structural characterization of biopharmaceuticals in more economical and efficient ways.[1] Unlike small molecule active pharmaceutical ingredients (APIs) that exist as a single chemical entity, biologics nearly always exist as a mixture of molecules. Different molecules can arise from numerous sources including N-terminal variants, post-translation modifications (PTMs), glycoforms, and degradation products. Due to the potentially high amount of heterogeneity in the biologic, it is critical to demonstrate control over the drug substance (DS) manufacturing process from fermentation to purification and protein re-folding. Characterization of the various molecules is the first step in demonstrating process control. High-resolution mass spectrometry is a key component in the characterization of novel biologics and biosimilars.

Topics: Thought Leadership Resource Center Biologics Analytical Development

Understanding Biologics: Your Top 7 Questions Answered

The biologics market represents the leading edge of novel therapeutics and is the fastest growing cross-section of the pharmaceutical industry—by some accounts, increasing as much as eight percent annually, or twice the growth rate of small molecule therapeutics. With advancements in DNA technology and increasing investments in personalized medicine, the sky is the limit for the biologics industry. This Q&A with biologics expert, Cheryl Johnson, will address the most common questions asked about this rapidly growing therapeutic field.

Topics: Thought Leadership Biologics Analytical Development Parenteral Manufacturing

Video: Extractables and Leachables

Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality Research Institute (PQRI), and several other industry consortia have developed guidelines and best practices for these extractables & leachables studies.

Alcami has specialized knowledge of the most common materials of construction such as platinum-cured silicon, halobutyl rubber, cyclic olefins, polyethylene terephthalate (PET), polyvinyl chloride (PVC), and other elastomers. Vial and stopper configurations, spray pumps, and intravenous (IV) bags are among the most common packaging system components we evaluate. We welcome all routes of administration, including the more challenging prefilled syringes, blow-fill sealed vials, and laminated cans.

Topics: Company News Extractables & Leachables Analytical Development Drug Product Extractables Studies Videos

eBook: Elemental Impurities

The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> with an instrument-based approach on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods were non-specific and frequently failed to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredient. 

Throughout this guidebook, Alcami scientists will discuss heavy metal regulations, moving to a risk-based approach, the role of risk assessment in the manufacturing process, goals and accountability, and agency-accepted testing and filing strategy for elemental impurities

 


Topics: Thought Leadership Resource Center Elemental Impurities Analytical Development

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

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

Case Study: Medicines Development for Global Health

In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global Health (MDGH) came to Alcami to initiate work on moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). The project utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical New Drug Application (NDA) filing timelines. Now, the two companies are exploring new opportunities to help eliminate neglected tropical diseases that affect over 2 billion of the world’s most disadvantaged people.

Read this case study to learn more about how Alcami’s advanced analytical testing technology center supported MDGH's moxidectin’s US Food and Drug Administration (FDA) approval.

Topics: Resource Center Analytical Development

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 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