Key expertise

Solid State characterization

The need to investigate the solid state properties of APIs has become important in the pharmaceutical development industry. Physical properties can vary widely between batches, leading to batch-to-batch variability. Sometimes this can be attributed to difference in crystalline forms or mixtures of amorphous and crystalline.

Solid State

Our highly skilled scientists can undertake studies that range from routine to highly complex and challenging characterization. We can perform physical and chemical characterization of Active Pharmaceutical Ingredient (API) and Drug Product during all phases of the drug development process. A clear and concise report will be provided summarizing all findings and can be QA reviewed for GMP projects.

Seqens has the industrial experience to manufacture API polymorphs in a stable and reproducible manner and offers the convenience of partnering with you to customize particle size distribution to your specifications.

In addition, Seqens has significant expertise in developing chiral pure APIs from its existing catalogue of racemic APIs and can apply our processes to racemic molecules produced by other manufacturers.

Solid state science drug development track record:

Baclofen/R-Baclofen
Cinacalcet synthesis
Esomeprazole trihydrate/dehydrate

Why choose Seqens’Lab for Solid State Services ?

Seqens’Lab provides a comprehensive and integrated offering to support pharmaceutical development (early up to late phase). This R&D center has a long-term expertise in Solid State Characterization on site to support custom and proprietary Active Pharmaceutical Ingredient development. All methods and testing can be performed under GMP requirements and are EU-GMP inspected.

Seqens’Lab possesses a comprehensive State of the art equipment allowing high capacity and fast turn-around, supporting development, stability and batch release.

Our experts develop in-house generic methods for a variety of techniques to eliminate the need to develop a method from scratch.

We can transfer compendial or client-provided methods, per cGMP, as well as develop new methods when no current method exists.

Our state-of-the-art PAT (Process Analytical Technology) supports process optimization and scale-up (Blaze 900 in situ probe which provide chord length distribution, high resolution imaging and Raman characterization).

Spray-drying

Low aqueous solubility of active pharmaceutical ingredients (APIs) often translates to poor bioavailability that can be a cause of failure during drug development. As such, improved aqueous solubility is a primary objective of formulation development, especially for oral, inhaled, and topical drug treatments.

Spray drying is an established particle engineering technology that involves producing dry powders from a fluid material through atomization into a hot drying gas medium, usually air or nitrogen. It offers several advantages over other particle engineering technologies, not least the capacity for continuous operation that removes any limitations on batch size. Other benefits of spray drying include rapid, scalable, cost-effective operation, and implicit compatibility with process analytical technology to safeguard highly reproducible drug production.

Spray drying is also more controllable, especially in the hands of an experienced API CDMO.

Micronization

The micronization of APIs is increasingly becoming a key capability for Contract Development and Manufacturing Organizations (CDMOs) as demand for semi-solid drugs, creams and gels continues to grow, as well as the use of APIs in foodstuff ingredients.

Micronization is a process for reducing the diameter of a solid material’s particles to enable the solubility of Active Pharmaceutical Ingredients (APIs). Whether administered orally or topically, this solubility is a key factor in bioavailability, and ultimately, the effectiveness of a drug.

Solid state technologies

Discover our Characterization of active pharmaceutical ingredients (APIs)

Pre-formulation testing capabilities

(inform platform)

Allows for precise pH control and monitoring, enabling you to study dissolution under conditions that mimic in vivo conditions more closely that other systems.
Provide biorelevant dissolution and solubility data (IDR, pKa, etc.)
Determine characteristic absorption patterns of raw materials

Equipment list

Empyrean Serie III Malvern-Panalytical XRPD and CHC chamber (resolved temperature and relative humidity control)
NMR Bruker Avance III 400 Mhz
Mettler DSC3
Mettler TGA/DSC3+
FP-80 HT Hot-stage microscope, Mettler
Malvern-Panalytical Particle Size Analyzer (LDPSD) Mastersizer 3000 (wet & dry)
Malvern-Panalytical Morpho-analyzer Morpholo M4 ID with Raman spectrocopy
Hosokawa Alpine Air jet Siever
Malvern-Panalytical DLS Zetasizer Pro Red
Microtrac BET Belsorp-Mini X
DVS Intrinsic (SMS)
Optical Light Microscopy
Hitachi TM-1000 Scanning Electron Microscopy
Perkin-Elmer FTIR Spectrocopy
Agilent Ultraviolet (UV) Spectroscopy
Sotax Powder Flow Tester

Discover other R&D services

Analytical Platform

Seqens provides GMP testing on Active Pharmaceutical Ingredients (API) and excipients. We have an extensive team focused on the development and clinical phase appropriate validation of sensitive and specific analytical methods

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Biocatalysis

Biocatalysis is the usage of enzymes as catalysts of chemical reactions. Learn more about Seqens extensive expertise.

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Bio
availability

Bioavailability

40% of drugs fail in preclinical trials due to bioavailability issues. Seqens has a strong expertise to support you regarding bioavailability challenges.

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Characterization

Characterization of APIs

Physical Characterization Testing Capabilities includes a full set of advanced technologies

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Drug Conjugates

The field of drug conjugates is emerging, with the possibility to achieve 2 functions with one (bifunctional) compound, usually allowing targeted therapies or improved bioavailability properties.

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Lipids

In the pharmaceutical industry, lipids are core excipients in the development of drug delivery systems. Lipids can be used in most dosage forms as support vehicles, solubilizers, permeation enhancers, stabilizers, transfection agents and release rate modifiers.

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Multipurpose Flow

Multipurpose Flow Chemistry

In flow chemistry, a chemical reaction is run in a continuously flowing stream rather than in batch production, leading to many key advantages.

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Polymers

Seqens strongly believes in the potential of new cutting-edge technologies to improve the use and efficiency of existing APIs. To support its customers, Seqens offers a range of drug delivery polymers.

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Synthetic Biology

Synthetic Biology for bioinspired and sustainable innovations

Part of Seqens group, Alganelle is an innovative biotechnology company at the cutting edge of synthetic biology and metabolic engineering.

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