Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis

by Alcami Corporation, on Jan 18, 2021 2:16:48 PM

Excerpted from Drug Development & Delivery - January/February 2021 Issue.

The global pharmaceutical analytical testing outsourcing market was estimated at $6.1 billion in 2019 and is anticipated to register a CAGR of 8.3% through 2027, according to Grand View Research, Inc.¹ Increasing demand for analytical drugs, biosimilars, and biopharmaceuticals are contributing to market growth. Other factors such as increasing investments in R&D for pharmaceuticals, rising demand for product safety and quality, and changing regulations for in vivo and in vitro tests are also expected to drive the demand for pharmaceutical analytical testing outsourcing services. Additionally, the development of combination products, biosimilars, and other innovative medicines has led to an increase in demand for specific types of pharmaceutical analytical tests, such as bioanalytical testing, method development and validation, active pharmaceutical ingredient testing, and stability testing.

Topics: News & Events Editorials Analytical Testing Blogs

Alcami Expands Oral Solid Capabilities with Investment in Wilmington, NC

by Alcami Corporation, on Jan 7, 2021 8:12:24 AM

Alcami, a leading United States-based contract development and manufacturing organization (CDMO), announced an additional $2 million investment to expand its oral solid development and manufacturing capabilities in Wilmington, NC. The investment will add a Gerteis Mini-Pactor® roller compactor and low humidity suites to Alcami's existing 140,000 square foot campus in Wilmington, NC. The expansion, which is on track to be completed in the first and second quarter of 2021, respectively, adds dry granulation capabilities and increased flexibility to support moisture-sensitive processes.

"We are pleased to support our customers' clinical to small scale commercial supply needs with modern, flexible, and reliable capacity," commented Walt Kaczmarek, CEO of Alcami. "Our investment in Wilmington is another step in our continued growth strategy to become the preferred provider of drug product and analytical services in the pharmaceutical industry."

Topics: News & Events Blogs

Risk Mitigation in the CDMO Space

by Alcami Corporation, on Dec 17, 2020 9:12:19 AM

Excerpted from Pharma's Almanac roundtable discussion in their Q4 2020 edition.

Although there is no such thing as a truly “crisis-proof” organization, how are you working to mitigate risks for future crises like the COVID-19 pandemic?

We’ve learned this year to expect the unexpected, and I don’t think any organization can be 100% “crisis-proof.” Still, at Alcami, we work very hard to be proactive and prepared for anything that may come our way. This effort applies beyond natural disasters and force majeure events to anything that may not go as planned. I’m confident anyone working in drug development would agree; unforeseen challenges will inevitably arise somewhere along the way.

At Alcami, our size enables us to adjust quickly and adapt to crises. For instance, this year we have embraced remote working and virtual solutions. Alcami employees have been amazingly creative and persistent in overcoming other challenges like supply chain issues that have come with the pandemic. We’ve maintained operations at all sites and even have a new sterile facility in RTP, North Carolina, on schedule to be operational in October.

Topics: News & Events Supply Chain Editorials Blogs

Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential

by Alcami Corporation, on Dec 16, 2020 9:28:26 AM

Today’s technology has not only changed the way we receive information, but has continually adapted and progressed how we acquire information. The analysis of metals in pharmaceutical actives (API), raw material, and drug products has changed as well. ICP-MS/OES has emerged as a critical analytical platform for this analysis.

Download White Paper: Leveraging ICP- MS To Its Full Potential

Topics: News & Events Analytical Testing Analytical Development White Paper / eBook Blogs icp-ms

Prepping Fill/Finish Systems to Ensure Quality Output

by Alcami Corporation, on Dec 7, 2020 9:06:35 AM

Excerpted from BioPharm International's editorial titled, "Prepping Fill/Finish Systems to Ensure Quality Output."

A holistic approach to validation and quality assurance is essential.

Biologic drugs are highly valuable in treating diseases, and assurance of sterility and proper final product quality is essential. Appropriate testing must be conducted to ensure the filled vials, syringes, cartridges, etc. contain the correct quantity of sterile, contaminant-free product. Aseptic process simulations are crucial for the assessment of aseptic filling capabilities.

The best approach, agrees Maria Lacourt, director of manufacturing operations for Alcami, is to conduct a holistic assessment of all the controls for the process and work toward a facility design that ensures proper execution of the process. “Beyond meeting requirements for the relevant room classification, the right equipment must be identified that enables optimum performance within appropriate containment systems such as isolators, which ensure reduced intervention of operators during aseptic processing.”

Topics: News & Events Editorials Blogs

Alcami Presenting Beyond Elemental Impurities: New Applications of ICP-MS Webinar

by Alcami Corporation, on Nov 24, 2020 9:07:36 AM

Join Alcami on December 9

You're invited to take part in a live webinar on Wednesday, December 9 from 11:00 am to 12:00 pm EST. During this webinar, scientific experts will highlight several newer applications of ICP-MS in the pharmaceutical industry that capitalize on the technique’s versatility outside of the scope of elemental impurities.

Topics: Events News & Events Webinars Elemental Impurities icp-ms

Alcami Presenting Environmental Monitoring Webinar on November 18

by Alcami Corporation, on Oct 26, 2020 8:58:36 AM

Join Alcami on November 18

We're launching our new environmental monitoring & cleanroom service offering with an interactive webinar on Wednesday, November 18 from 11:00 am to 12:00 pm EST. Join environmental monitoring expert, Katie Kovalevich, to learn about our newest capability.

"I've serviced over 150 cleanrooms and am thrilled to problem solve and share what I know on this critical need for so many industries," said Katie Kovalevich, Laboratory & Environmental Monitoring Sales & Marketing Manager. "If you have questions prior to the webinar, you can also schedule a meeting now."

Topics: Events News & Events Cleanroom Services Environmental Monitoring

Alcami Attending CPhI Festival of Pharma

by Alcami Corporation, on Oct 2, 2020 9:31:34 AM

Schedule to meet with Alcami at Festival of Pharma


CPhI Festival of Pharma is a virtual gathering launched to bring the global pharma industry together online, the Festival of Pharma fills the gap left by in-person events at a time when travel and gatherings are off the cards to let you connect with companies and clients from around the world.

Topics: Events News & Events

Alcami Continues to Execute Strategic Plan to Focus Its Platform with Sterling Pharma Solutions’ Acquisition of API Facility in US

by Alcami Corporation, on Sep 30, 2020 11:58:11 AM

Global contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions, has announced its acquisition of Alcami’s Germantown, Wisconsin facility in the US.

The new facility will further bolster Sterling’s US presence and will provide additional capacity for customer API development and manufacturing projects, specifically those with complex and hazardous requirements. The Germantown facility houses state-of-the-art cGMP development, scale-up and manufacturing facilities. Germantown has specialist expertise in handling technologies including plant-scale hydrogenation and cryogenic reactions.

Topics: News & Events Blogs

Alcami Hosting Virtual Open House of New Sterile Fill-Finish Development & Manufacturing Facility

by Alcami Corporation, on Sep 29, 2020 2:27:27 PM

Join Alcami on Friday October 9

We're kicking off the opening of our new formulation and sterile fill-finish facility with a digital open house on October 9 from 1:00 to 2:00 pm EDT. Join key members of Alcami's operational and commercial leadership teams to learn about our newest facility featuring four filling lines with isolator and flexible manufacturing technology.

Topics: Events News & Events Formulations Parenteral Manufacturing

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