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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

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 ingredients. 

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

Editorial: An Interview with Alcami

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. 

Take a Virtual Tour of Our Sterile Fill Line 1

Topics: Thought Leadership 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.

Take a Virtual Tour of Our Granulation Suite

Topics: Thought Leadership Editorials Oral Solid Dose

Editorial: HPAPIs - A CDMO View

Alcami recently contributed to an article in Specialty Chemicals Magazine titled "HPAPI's: A CDMO View."

Alcami has gained extensive knowledge on HPAPI manufacturing from building new suites at its US API development and manufacturing site

Over the course of 2016-2017, global CDMO Alcami built and qualified a new facility for highly potent compounds at its facility in Germantown, Wisconsin. During the design phase, says Adam Kujath, global senior director of manufacturing science & technology, the company put considerable thought into what was needed to match its existing capabilities – it has a very diverse customer base and works with many different molecules – to market needs.

Take a Virtual Tour of Our HPAPI Suites

Topics: Thought Leadership HPAPI Editorials

Editorial: Fuelling Pharma's Innovation Engines

Alcami President & Chief Executive Officer Dr. Stephan Kutzer recently took part in an interview for Manufacturing Chemist titled "Fuelling Pharma's Innovation Engines." 

According to Stephan, small and mid-size pharma and biologics companies are the innovation engines of the industry. “Each year, the number of new INDs and NDAs increases and we anticipate this trajectory to continue. We see more than 5000 clinical introductions on an annual basis. Cancer treatments are a particular area of focus for many of our clients and we expect our pipeline for these therapies to grow within the next 5 years. Our target accessible market is around $8 billion.”

KR: How does Alcami plan to grow with the industry?

SK: We have strategically invested in capability extensions and operational excellence initiatives to better meet industry demand. At our Germantown (Wisconsin, USA) Center of Excellence for API development, scale-up and commercialisation, we have supplemented our existing pipeline with HPAPI suites and controlled substance capabilities.

Topics: Company News Thought Leadership Editorials

Beyond the Bench: UNC Wilmington Classroom to cGMP Laboratories

Alcami and the University of North Carolina Wilmington (UNCW) have partnered on an academic program that connects education and work experiences for students pursuing scientific careers, especially in pharmaceutical sciences. This edition of the Beyond the Bench series will highlight the laboratory-based course taught at UNCW’s state-of-the-art marine biotechnology center (MARBIONC), “Current Good Pharmaceutical Quality Control Laboratory Practice,” focused on the application of Current Good Manufacturing Practices (cGMPs) in a drug development and testing laboratory.

In 2016, leaders from Alcami and UNCW met to discuss potential opportunities to work together on biopharmaceutical projects. Many of Alcami’s Wilmington employees are UNCW graduates, and Alcami has a long history working with the university on employee education programs and pharmaceutical projects. Steve Fontana, JD, from UNCW’s Office of Intellectual Property and Commercialization; UNCW Chancellor Dr. Jose V. Sartarelli, and Alcami President and Chief Executive Officer (CEO) Dr. Stephan Kutzer initiated conversations that resulted in the development of the present partnership.

Topics: Thought Leadership Alcami in Action Alcami Voices

Staying Ahead of OSD Challenges

Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges must be immediately addressed to keep timelines on track. In early-stage OSD formulation development, complex solubility issues, difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API) all can lead to delays in development. During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physicochemical characteristics of a product.

Topics: Thought Leadership Serialization Oral Solid Dose Packaging

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