NEWS & EVENTS

Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis

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

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." 

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Risk Mitigation in the CDMO Space

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

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

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.”

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

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.

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Food Studies 101

Alcami’s scientists have substantial experience designing and executing food studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms. 

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients. Geriatric, pediatric, and patients suffering from gastroesophageal reflux disease are often administered pharmaceuticals mixed with food or liquids due to difficulty swallowing tablets or capsules. For immediate release, enteric coated, modified release, or extended release dosage forms, a food study is required to evaluate whether the alternate route of administration impacts the therapeutic dose.

Topics: News & Events Blogs Food Studies

Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK

Alcami, a US-based contract development and manufacturing organization, announced today that it is providing commercial manufacturing services for Trevena’s newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in adults for the management of acute pain severe enough to require an intravenous opioid analgesic. Alcami has provided development and clinical support for this program for several years leading up to Trevena’s approval from the U.S. Food and Drug Administration.

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Alcami RTP Expansion Nears Completion

MORRISVILLE, N.C., July 28, 2020 -- Alcami, a US-based contract development and manufacturing organization (CDMO), is pleased to announce that its 56,000 square foot expansion in Research Triangle Park (RTP), reached the first milestone of operational readiness with the start of GMP laboratory testing this month. This brand-new site with state-of-the-art design and controls became part of Alcami when TriPharm Services was acquired in January 2020. 20,000 square feet will be dedicated to microbiology, formulation development, and analytical chemistry services.  Specific investment has been made to offer industry-leading environmental monitoring services from this site in 2020. Operational capabilities will continue to build across the next two years with the completion of Phase 1 of the manufacturing facility in Q4 2020, which will bring the first two filling suites online and the next major milestone.

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505(b)(2): What You Need to Know

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). A 505(b)(2) application is a hybrid between the FDA's traditional NDA and an abbreviated new drug application (ANDA). These submission types were made possible in 1984 by the adoption of the Hatch-Waxman Act. The act was created to allow for generic competition and increased innovation in the pharmaceutical arena. A true generic or ANDA demonstrates that the drug is identical to an already approved product based on bioequivalence data and chemical equivalence. 

Topics: News & Events Regulatory Compliance Blogs 505(b)(2)