Extractable and Leachable Studies

Dedicated to manufacturing parenteral dosage forms, Alcami’s Charleston, South Carolina site supports preclinical production through commercial launch and supply. This US- and EU-compliant and DEA-licensed sterile manufacturing facility is fully integrated with our Wilmington, North Carolina packaging and ...

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...

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...

Method development and phase appropriate validations to support clinical and commercial programsCompendial Testing
Raw Material Testing

Development and optimization of suitable manufacturing processes to support clinical and commercial programs

Support stand along packaging activities or integrated with Alcami's manufacturing capabilities. Can support packaging for clinical kits including kit assembly and commercial packaging.

Fill / Finish services to support biologics.

Formulation development and optimization to support all stages of clinical programs.

Developing and optimizing lyo cycles to support clinical and commercial programs

Tech Transfer and Scale up to support clinical and commercial programs

Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation 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...

The CDMO will supply expertise in GMP sterile fill-finish manufacturing and controlled-substances

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.

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. 

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.

Alcami scientific experts go back to the basics to examine the importance of stability in pharmaceuticals.

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!

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.

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.

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.

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.

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.

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.

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.