Parenteral manufacturing
Product Description
Alcami
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US -
2016On CPHI since
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1000 - 4999Employees
Company types
Categories
Specifications
Alcami
-
US
-
2016On CPHI since
-
1000 - 4999Employees
Company types
More Products from Alcami (17)
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Product Biopharmaceutical development
From initial characterization of drug substance to commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality. With these critical attributes in mind, Alcami’s biologics analytical devel... -
Product Formulation development
Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic. Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer... -
Product Integrated offerings
Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
Core Capabilities:Sterile-fill finish development and manufacturingO... -
Product Manufacturing
Alcami offers cGMP manufacturing services with operations ready to scale in tandem with your development and approval milestones. From preclincial through commercial supply, Alcami’s development and manufacturing sites are DEA certified to manage controlled substances, APIs, and other complex compounds. Al... -
Product Microbiology
Microbiological testing is an important factor in ensuring your product’s safety, efficacy, and timely project completion. At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective... -
Product Packaging and labeling
Alcami provides custom packaging, labeling, and kitting for clinical trial materials destined for trials anywhere in the world. We also provide specialized expert support for randomization and blinding studies, including placebo, comparator, and crossover studies, as well as reconciliation drug accountabil... -
Product Solid oral dose
Specialized to manufacture oral solid dosage (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. We differentiate ourselves by providing ample problem-solving solutions to your scientific needs.
Our cGMP manufact... -
Product Stability
Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
-Formulation development studies including stress studies
-Photostability (Options I and II)
-Comparator studies
-Thermal cycling/freeze thaw
-Shipping excursion studies
-Long-term stabi... -
Product Analytical Services
Method development and phase appropriate validations to support clinical and commercial programsCompendial Testing
Raw Material Testing -
Product Contract Manufacturing
Development and optimization of suitable manufacturing processes to support clinical and commercial programs -
Product Contract Packaging
Support stand along packaging activities or integrated with Alcami's manufacturing capabilities. Can support packaging for clinical kits including kit assembly and commercial packaging. -
Product Extractable and Leachable Studies
Alcami’s expertise includes the assessment of a broad variety of drug products, routes of administration, and manufacturing system components. A proper assessment includes studies to not only understand which compounds have the ability to leach into the drug product, but also studies to identify which comp...
Alcami resources (18)
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News Alcami to manufacture PharmaTher’s proprietary ketamine products
The CDMO will supply expertise in GMP sterile fill-finish manufacturing and controlled-substances -
Brochure Food Studies Brochure
Alcami is equipped and ready to handle study design and execution of food studies to support a variety of oral solid dosage forms, including tablets, capsules, and suspensions. Our subject matter experts have developed and executed studies using infant formula, yogurt, orange juice, apple sauce, smoothies, and a variety of other foods and drinks. -
News RSVP for Formulation & Sterile Fill-Finish Online Open House!
Sign-up below to be part of an open house with key members of Alcami's operational and commercial leadership teams for sterile fill-finish manufacturing services on October 9. -
News Jacque Uribe and Elliott Franco Join Line-Up for Open House
Join us this Friday for the opening of our new formulation and sterile fill-finish facility with a digital open house 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. RSVP below. -
Whitepaper Stability eBook
Alcami scientific experts go back to the basics to examine the importance of stability in pharmaceuticals. -
News New Formulation & Sterile-Fill Finish Facility Online Open House on Oct 9
We’re kicking off the opening of our new, 32,000 sq. ft formulation and sterile fill-fill finish facility with a digital open house on October 9 from 1:00-2:00 pm EDT. We have a range of technical experts as our speakers including Maria Lacourt, Ken Domagalski, Jacque Uribe, Yadira Salamander, and Kim McClintock. Join us! -
Video Alcami RTP Laboratory Video
Enjoy a look inside our brand new laboratory in Research Triangle Park, North Carolina. This state-of-the-art facility houses formulation development, chemistry, microbiology, and environmental monitoring capabilities in support of our also brand new formulation and new sterile-fill finish facility in RTP. -
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Video Expanding the OSD toolbox with an industry-based approach to lipid and surfactant adsorption onto dry powder excipients to increase the dissolution rate of BCS Class II and Class IV active pharmaceutical ingredients (API’s)
Common high-performance lipids and surfactants were used to improve the dissolution rate of furosemide as a model compound for BCS Class II and Class IV active pharmaceutical ingredients. Furosemide equilibrium solubility was measured throughout an HLB range (1-16) of liquid lipids and surfactants. Furosemide tablets were then manufactured using high shear granulation to absorb the solubilized and suspended furosemide onto microcrystalline cellulose (Avicel PH101). The granulations were then compressed using a rotary tablet press and standard tablet tooling. Finished tablets were analyzed to compare dissolution rates using 0.1 N HCl media and USP Apparatus II. Higher equilibrium solubility yielded increased dissolution rates for furosemide tablets compared to directly compressed furosemide tablets. -
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Webinar Expanding the OSD Toolbox with an Industry-Based Approach to Lipid and Surfactant Adsorption onto Dry Powder Excipients to Increase the Dissolution Rate of BCS Class II and Class IV Active Pharmaceutical Ingredients (API’s)
Common high-performance lipids and surfactants were used to improve the dissolution rate of furosemide as a model compound for BCS Class II and Class IV active pharmaceutical ingredients. Furosemide equilibrium solubility was measured throughout an HLB range (1-16) of liquid lipids and surfactants. Furosemide tablets were then manufactured using high shear granulation to absorb the solubilized and suspended furosemide onto microcrystalline cellulose (Avicel PH101). The granulations were then compressed using a rotary tablet press and standard tablet tooling. Finished tablets were analyzed to compare dissolution rates using 0.1 N HCl media and USP Apparatus II. Higher equilibrium solubility yielded increased dissolution rates for furosemide tablets compared to directly compressed furosemide tablets. -
Whitepaper The Changing R&D Landscape: Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs)
We expect the importance and value proposition of manufacturing to exponentially increase in the next decade and the foreseeable future. Most importantly, parenteral manufacturers need to move away from a myopic "fill-finish" mentality to a fully integrated development mindset that is in line with client expectations, patient needs, and regulatory requirements. It will require "out of the box" thinking and strategic, at-risk investments to remain ahead of the curve. This will take innovation, courage, and collaboration across R&D and placing smart bets for a win-win. -
Whitepaper Structural Characterization of Biologics Using High-Resolution Mass Spectrometry
High-resolution mass spectrometry is a core technique for the characterization of biologics. It can provide a full range of characterization capabilities ranging from high-level analysis through intact mass analysis to residue-specific information from MS/MS sequencing. Alcami offers a full range of capabilities for the structural characterization of biologics using high-resolution mass spectrometry. Instrumentation includes two high-resolution quadruple time of flight (Qtof) instruments and multiple high sensitivity triple-quadrupole instruments. -
Video Video of Alcami's Newest Laboratory Facility in RTP, North Carolina
Enjoy a look inside our brand new laboratory in Research Triangle Park, North Carolina. This state-of-the-art facility houses formulation development, chemistry, microbiology, and environmental monitoring capabilities in support of our also brand new formulation and new sterile-fill finish facility in RTP. -
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Whitepaper Design and Execution of Food Studies
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.
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