Drug Product Manufacturing

Formulation Development

Biologics
Drug Product Manufacturing
Formulation Development
Laboratory Services

Alcami’s formulation development team guides your development program every step of the way.

For years, Alcami’s formulation development team has been solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms. For more than 45 years, we’ve supported over 500 Investigational New Drug (IND) filings and over 50 New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and New Animal Drug Applications (NADAs).

Alcami’s scientists provide full chemistry, manufacturing, and controls (CMC) services for drug candidates — encompassing all biopharmaceutical classification system schemes (BCS Class I through Class IV), including the more challenging not freely soluble, unstable, or poorly bioavailable compounds. Our formulation and analytical experts will develop creative solutions to your toughest pharmaceutical challenges, including products with extremely low or high drug loads, poor flow, or homogeneity problems.

We’ve developed our operations and quality systems to process small and large molecules effectively and efficiently for administration by injection, including solutions, suspensions, emulsions, and lyophilized products. Our team of formulation development experts have successfully transferred these product types for clinical and commercial use.

Formulation Development Core Capabilities

Accelerated first-in-human clinical trial materials

API polymorph screening

API salt form selection

API structural chemistry

Bioavailabilty enhancement

Blinding and over-encapsulation

Clinical formulation development

Commercial dosage form design

Drug candidate selection

Drug excipient compatibility studies

Drug product lifecycle management

Drug substance preformulation studies

Injectable prototype development

Matching placebo development

Pediatric formulation development

Pharmaceutical process development

Powders for reconstitution

Preclinical formulation development

Quality by design (QbD)

Solid oral dose prototype development

Technology transfer and process scale-up

  • Biologics Formulation Development

    Alcami offers comprehensive analytical services for biologics throughout the drug development lifecycle, utilizing a range of analytical techniques to design robust control strategies, conduct extensive characterization, and perform essential testing, ensuring product quality, safety, and efficacy from early-stage development through commercialization.

    Binding / Potency

    Cell-Based Assay, ELISA, Enzyme Activity, Kinetic Analysis, Concentration by UV/Vis​

  • Identification

    Sequencing by LC/MS, Accurate Mass, Unknown Peak ID, Western Blot, SDS-PAGE

  • Characterization

    Peptide Map, Amino Acid Analysis, Oligosaccharide Analysis, Glycosylation Profile, Gel Permeability, Physicochemical Properties, Analytical Ultracentrifugation​

  • Safety

    Residual HCP & DNA, Bioburden & Endotoxin, Sterility & CCIT, Sub-visible Particulates (HIAC and MFI), Stability Storage & Testing, Extractables & Leachables, trace metals by ICP​

  • Purity

    HPLC/UPLC (IP, RP, SEC, IEX, HILIC, HIC, DAR), Electrophoresis (CE-SDS, SDS-PAGE, IEF & cIEF), Extinction Coefficient (GC, UV-Vis) ​

Related Topics
Drug Product Manufacturing
Laboratory Services
Biologics
Analytical Method Development
Contact Alcami
Summary

Alcami offers comprehensive formulation and analytical services for both small and large molecules, specializing in complex drug formulations and biologics. With over 500 IND and 50 NDA/ANDA/NADA filings,we support clients from early development to commercialization, ensuring product quality, safety, and efficacy through integrated formulation, analytical techniques, and robust control strategies.

Related Topics
Drug Product Manufacturing
Laboratory Services
Biologics
Analytical Method Development
Contact Alcami
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