Biologics Formulation Development - Abzena

Biologics Formulation Development

Over 20 years of biologic formulation development expertise, data and knowledge tailored for your product.

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Tailored formulation development.

Biologics are known for their intricate molecular structures and precise therapeutic actions. They demand a sophisticated formulation process tailored to their unique characteristics and stability needs. At Abzena, our experienced scientific team specializes in developing complex biological compounds, harnessing the latest technologies to assist in optimizing each formulation for solubility, delivery, safety, and sustained stability.

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Customized for your molecule and development phase, Abzena align your drug to your preferred target product profile (TPP) with a comprehensive range of formulation development packages including stable liquid and lyophilized formulations.

We select your best lead candidate through screening of optimal buffer conditions and formulation options to inform successful drug substance manufacturing conditions and drug product forms that support long-term stability.

Our team is experienced in developing formulations for small and large therapeutic molecules such as peptides, proteins, monoclonal antibodies and antibody-drug conjugates (ADCs).

Navigate the complex concept-to-market pathway with the full support Abzena.

Our customer-centric approach across a broad range of formulation development services enables us to support a biopharmaceutical product throughout its entire lifecycle – from initial preformulating studies and generation of a formulation to support toxicology and first-in-human (FIH) clinical trials through to clinical in-use studies, formulation optimization, robustness, and device interaction studies.

Fully Integrated Formulation Development Support

Abzena Cambridge Chemistry Lab - Abzena

Our unique approach enables customers to utilize a single organization for all their formulation and manufacturing requirements, which streamlines and de-risks the process and allows any experience and learnings to be shared across teams. This first-hand knowledge of the product can then be applied to rapidly solve any complex problems which may arise downstream.

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Our Formulation Development Capabilities

Our state-of-the-art laboratories are equipped with the latest analytical equipment and methods to evaluate the integrity of your drug under an array of conditions to inform optimal formulation constituents and forms.

Our capabilities include:

  • UHPLC systems
  • Biophysical stability assessment platforms and particle size assessment equipment such as Prometheus, UNcle and ZetaSizer Ultra
  • Mass spectrometry instruments (TOF MS, QTOF MS)
  • Microfluidic platform (LabChip)
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What sets our biologics formulation development services apart?

  • We have delivered delivered over 1400+ programs, developing formulations for a diverse range of therapeutic modalities
  • Fully integrated, comprehensive formulation development support across: mAbs, ADCs, AOCs, Radioconjugates, Bispecifics, Fusion Proteins, Cytokines, Recombinant & Conjugate Vaccines, Nanoparticles and Biosimilars
  • Experience of supporting clients with all stages of drug development, from discovery through product launch and subsequent life-cycle management
  • Problem solving and applying knowledge to provide product-enabling solutions e.g., addressing viscosity or solubility issues
  • A number of returning customers emphasize their confidence and trust in our complex biologic development abilities
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Related

Analytical Development

Your product development program will be accelerated by leveraging our expansive in-house capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.

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Process Development

Our experts collaborate together to develop quality, commercially viable processes ensuring seamless scale up through to commercial launch.

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Cell Line Development

AbZelectPRO™ is our cell line development solution which can rapidly progress therapeutic protein & recombinant vaccine programs from DNA to RCB in 10 weeks.

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Let’s move medicine forward - Abzena

Let’s move medicine forward.

We understand the important role that formulation development plays in ensuring both clinical and commercial success for your program. From early discovery through commercial, our experienced scientists can ensure that your new medicine reaches patients in need.

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