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Bringing innovation
to life

From research and development to pharmaceutical manufacturing

At AMW, innovation is at the heart of everything we do – from the laboratory to improved therapies for patients. We develop biodegradable long-acting implants based on a data-driven development approach, focused on clinical implementation.

AMW employee in the testing laboratory
Focus on the patient

Research & development at AMW

The release profile of biodegradable long-acting implants is highly complex: polymer degradation, drug diffusion, implant geometry, manufacturing processes and the biological environment all interact to determine how long a drug remains within its therapeutic window. While conventional in vitro release tests provide valuable insights, they can only partially reflect the actual behavior of an implant in the human body. To address this challenge, we combine our longstanding formulation expertise with preclinical pharmacokinetic studies and data from our own clinical trials. This integrated approach provides a deeper understanding of how biodegradable implants perform over weeks or months - and how their release characteristics can be precisely controlled. Our goal is to develop formulations that enable consistent and reliable drug exposure throughout the entire treatment period: high enough to maintain a stable therapeutic effect, while avoiding unnecessary peak concentrations that may increase the risk of potential side effects. From preclinical development through scale-up into clinical GMP manufacturing, we systematically translate this know-how into robust manufacturing processes and clinically relevant products.

Implants in a laboratory vessel
Laboratory staff in conversation
Application syringe for implant
Controlled release drug delivery systems

Tailored biodegradable implants

Many therapies require reliable drug exposure over extended periods of time. In clinical practice, this can be challenging due to frequent treatments, complex dosing regimens, fluctuating drug levels or insufficient drug availability at the target site. To address this, biodegradable long-acting implants offer a modern drug delivery approach: they are administered once and subsequently release the active pharmaceutical ingredient (API) in a controlled manner over weeks or months. As a result, they can help simplify treatment for patients while supporting a more consistent therapeutic effect. Particularly for therapies targeting localized sites of action, implants enable the targeted delivery of drugs directly to or near the desired location - including tissues or body compartments that may be difficult to reach through systemic administration alone.

Biodegradable long-acting implants can offer several potential advantages:

  • They target a controlled drug release over weeks or months.
  • They can help maintain drug concentrations within the therapeutically relevant range for extended periods.
  • They support local drug delivery close to the target tissue and may thereby limit systemic drug exposure.
  • They can reduce peak and trough concentrations that may occur with repeated dosing.
Implants in a laboratory vessel
  • They reduce the need for frequent administration and may therefore lessen the treatment burden for patients.
  • They may support treatment adherence by reducing the risk of dosing errors, missed doses or irregular administration.
  • After completion of drug release, they gradually biodegrade, typically eliminating the need for surgical removal.
Innovative drug delivery systems

Our development pipeline 


Our pipeline comprises development projects at various stages - from early formulation development to commercialized products. The focus is on the development of innovative drug delivery systems for well-known and, in many cases, already approved active pharmaceutical ingredients. AMW develops formulation and release technologies that can translate APIs into new therapeutic profiles. These include controlled release rates, extended durations of action and exposure profiles that are often difficult to achieve with conventional oral or intravenous dosage forms. Depending on the API and indication, our systems can help improve therapeutically relevant drug exposure, reduce fluctuations in drug concentrations, decrease dosing frequency and enable more targeted drug delivery at or near the site of action. Our projects address a range of therapeutic areas, including oncology, ophthalmology, obesity, diabetes, cardiovascular diseases and disorders of the central nervous system.

Indication
Product
R&D
Preclinical
Clinical
Submission
Market
Oncology
Oncology
AM0801
Oncology
AM0802
Oncology
AM0803

mRNA eluting biodegradable implant as a next-generation gene therapy pathway. Prototyping and plausibility studies concluded.

Long-acting biodegradable leuprolide implant with an improved formulation designed for reliable, controlled 1-month release. Multiple formulation groups currently evaluated to identify lead candidate for subsequent process development and clinical translation.

Ophthalmology

Long-acting biodegradable intravitreal implant designed to release an active ingredient for 6+ months. Target indications include age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion.

Obesity, cardiovascular diseases, diabetes

Development of a long-acting biodegradable implant for the delivery of GLP-1 agonists indicated for metabolic syndrome-related indications, targeting sustained release over approximately 3 months.

CNS

Confidential

Know-how & experience

The AMW approach

AMW develops biodegradable long-acting implants across the entire product and process development lifecycle - from the selection of suitable polymer classes to formulation design and process optimization up to transfer into GMP manufacturing. A key development objective is to achieve a highly consistent, ideally near-linear drug release profile throughout the intended treatment period. This is particularly challenging with conventional biodegradable polyesters such as PLA, PLGA and related materials, as water uptake, diffusion, polymer degradation and pore formation can lead to multiphasic release profiles. To address this, AMW goes beyond the use of individual standard polymers and strategically expands the formulation space by using binary and ternary polymer blends. This enables the systematic optimization of degradation behavior, mechanical properties, drug distribution and release profile. Manufacturing is based on melt extrusion technology. AMW not only considers the extrusion step itself but the entire process, including upstream and downstream development - from material preparation, particle size control, drying, blending and dosing to cutting, sorting and in-process monitoring. The use of comparable equipment technologies in both R&D and GMP cleanroom environments facilitates efficient technology transfer at later stages. To accelerate development, AMW combines historical formulation data, machine-learning-supported data analysis, rapid prototyping and statistical Design of Experiments (DoE) methodologies. This approach enables the identification of optimal formulations within a defined design space while minimizing the number of experimental iterations required. By combining materials expertise, process understanding, analytical capabilities and GMP experience, AMW has established an integrated development approach for robust, scalable and clinically relevant long-acting implants.

Our commitment

Quality by Design

AMW applies Quality by Design (QbD) as a core development principle for biodegradable long-acting implants: Quality is not just assessed in the final product, it is built into development from the outset through the definition of the target product profile, critical quality attributes and relevant material and process parameters. This approach is particularly important for polymer-based long-acting formulations, where material properties, process control and product performance are closely interconnected. AMW combines this approach with advanced analytical methods, statistical design of experiments and in-depth process understanding. This enables the systematic evaluation and control of release characteristics, drug content, stability, degradation products and critical process parameters.

Laboratory worker performing lab work
Materials characterization and formulation
  • Microscopy image analysis: An essential tool for evaluating the morphological characteristics of the formulation. This process enables an in-depth examination of microscopic structural properties, supports formulation optimization, and allows for predictions regarding release kinetics through the precise determination and quantification of particle size distribution and other relevant factors.
  • ATR-FTIR spectroscopy: An important technology for determining the chemical composition of materials. It allows for a detailed examination of the molecular structures and interactions that are crucial for ensuring the distribution and homogeneity of the various components within the formulation.
  • GPC (gel permeation chromatography): This method determines the molecular weight distribution of polymers in the formulation. It provides fundamental insights into the potential, unintended degradation of polymers as well as into process stability.
  • DSC (differential scanning calorimetry): A key tool for characterizing thermal properties of materials, which provides important information on the glass transition temperature of the polymer components and the solubility of the API in the polymer matrix, thereby enabling significant optimization of the manufacturing process.
  • Rheology: This technique measures the flow properties of formulations, thereby defining the process range for extrusion and ensuring a consistent torque curve during extrusion, which contributes to higher product quality.
Analytical testing
  • HPLC (high pressure liquid chromatography) / UPLC (ultra high performance liquid chromatography) combined with UV/RI/fluorescence and MS detection are essential tools for the quantitative analysis of the API and potential degradation products in pharmaceutical formulations. This method plays a key role in determining release kinetics and in monitoring the content and purity of the implant.
  • Coulometric water content determination: A method used to determine the water content in the formulation, which can influence the stability during the extrusion process as well as the degradation und release kinetic.
Product testing and validation
  • Mechanical testing of materials: An important process for evaluating the mechanical properties of the product, which provides detailed information on the product’s behavior under various physical stresses, such as those that may occur during the handling of the implant or during assembly.
  • In-vitro-release tests in accordance with the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopeia (USP), and our own methods: These tests, which are conducted in accordance with regulatory guidelines to the greatest extent possible, are crucial for determining the release kinetics of the APIs. However, if necessary, the tests can be modified to account for the specific properties of biodegradable polymers, which is central to the evaluation of the product’s potential clinical efficacy.
  • ICH stability studies (all climate zones): These studies are crucial for determining product stability under various environmental conditions in different market regions.
     
Hot Melt Extrusion (HME)

Melt extrusion

AMW’s biodegradable implants are manufactured using melt extrusion technology. Hot Melt Extrusion (HME) is a continuous, solvent-free process in which the API, polymer matrix and, where applicable, excipients are processed under controlled temperature, pressure and shear conditions and formed into a defined implant geometry. In pharmaceutical development, HME is widely used for the production of controlled-release dosage forms and implants. AMW considers melt extrusion as part of an integrated manufacturing process. Process parameters such as temperature profile, screw speed, residence time, shear stress and throughput are specifically tailored to the API, polymer and desired release profile. Depending on the drug–polymer system, the API may be present within the matrix in a crystalline, amorphous, molecularly dissolved or finely dispersed state. This solid-state form is a critical factor influencing stability, processability and release behavior. AMW therefore specifically uses melt extrusion to develop degradable implants with a reproducible composition, defined dimensions and controlled drug release over the intended treatment period.

Size comparison of the implants
Hot Melt Extrusion Illustration
Advantages HME holds over other formulation techniques
  • Enhanced solubility and bioavailability: HME can enhance the solubility of poorly water-soluble API, which potentially leads to improved bioavailability in the body.
  • Continuous manufacturing: HME is ideally suited for continuous manufacturing, which not only offers the potential for reduced manufacturing costs, but also enables consistent product quality and simplified scaling from early development to commercial production.
  • No solvents: Unlike other technologies, HME typically does not require solvents, which simplifies the formulation process and makes the technology more environmentally friendly.
  • Flexibility in formulation: HME can be used to produce a wide range of dosage forms, including tablets, capsules, and films, offering flexibility in formulation development.
  • Precise control of the release rate: The process allows for precise control of the release rates of API. This is achieved through careful selection of polymers and science-based optimization of process parameters.
  • Uniform dispersion of the API: Melt extrusion can be used to produce formulations with a homogeneous distribution of the API. This enables controlled release and can thus minimize the occurrence of side effects caused by dose peaks.
  • Complex matrix formulations: HME enables the development of complex matrix formulations that can incorporate multiple API with varying release profiles. This represents a significant advantage in the development of combination therapies.
  • Stability: Formulations produced via HME are often characterized by high stability, protecting sensitive APIs from degradation throughout the product’s shelf life.
  • Regulatory acceptance: HME is widely accepted by regulatory authorities for the approval of pharmaceuticals, which can potentially simplify the approval process. This offers an advantage over products manufactured using processes that are technically more complex and more difficult to monitor.
Limitations

Despite its central role in pharmaceutical development, HME is not without its challenges, particularly when it comes to the suitability of APIs. The following section describes some of the potential limitations and requirements for active pharmaceutical ingredients in the context of HME:

  • Thermal stability: Active ingredients that are heat-sensitive may degrade during the extrusion process. However, through careful selection of components and targeted preliminary testing, the process conditions can be optimized to minimize damage to the active ingredient.
  • Formulation complexity: Developing formulations with precisely defined release profiles for pharmaceuticals can often be complex and requires extensive research and development to optimize the formulation’s characteristics.
  • Physical and chemical interactions: During the extrusion process, physical and chemical interactions can occur between the API and the matrix polymers. These interactions could potentially affect the stability or release characteristics of the final product.
  • Cost factors: The investment costs for an extrusion line can be substantial, especially when considering the highly specialized machinery and the necessary analytical instruments. Additionally, expenses may increase if specialized polymers are used in the formulation.
  • Limited to certain APIs: Due to their physical and chemical properties, not all APIs are suitable for HME. 
API requirements
  • Thermal Stability: The API should possess good thermal stability to withstand the high temperatures usually encountered during the extrusion process without undergoing degradation.
  • Compatibility with Polymers: The API should be compatible with the polymers and other excipients used in the formulation. It should maintain its stability and efficacy throughout the manufacturing process.
  • Adequate Solubility: APIs used in HME should have adequate dispersability in the polymeric matrix to ensure uniform distribution and effective release from the formulation.
  • Particle Size: The particle size of the API may need to be carefully controlled to achieve the desired drug release profile and to ensure uniform dispersion in the polymeric matrix. The optimum particle size is determined in preliminary tests and should vary only to a controllable and reproducible extent throughout the process chain.
  • Crystallinity: The crystallinity and crystalline form of the API can influence its release properties. In some cases, APIs may need to be processed to modify their crystallinity before being used in HME.
What we offer

A wide range of opportunities for innovation and collaboration

At AMW, innovation is driven by a broad range of research and development activities as well as dynamic partnerships. Our core technology is versatile, covers a broad spectrum of clinical areas and incorporates various chemical agents as therapeutic active ingredients. This environment forms the foundation for a robust development pipeline and paves the way for diverse, flexible collaboration models with companies in the pharmaceutical, biotechnology and medical technology sectors. AMW also offers collaboration opportunities in development, manufacturing and related services (CDMO+) as well as licensing and distribution partnerships.

Partner with us
Licensing & distribution
AMW employees at a meeting in the meeting room

Your contact

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FAQs on Innovation at AMW

Does AMW exclusively use biodegradable polymers?

AMW’s primary focus definitely is on biodegradable polymer matrices. Their key advantage is that the implant does typically not require surgical removal once drug release has been completed. This is also where our dedicated expertise lies: the release behavior of biodegradable materials is more complex than that of non-degradable matrices and requires a deep understanding of polymer degradation, drug diffusion and formulation design.

What are the advantages of melt extrusion, the technology AMW uses to manufacture long-acting implants?

There are various technologies to manufacture long-acting drug delivery systems. AMW deliberately focuses on melt extrusion because it is a solvent-free, highly controllable and industrially scalable process. Based on our experience, suitable polymer–drug combinations can be developed for a wide range of applications, enabling the desired release kinetics to be achieved through an extruded implant.

At what stage can AMW take over a development project?

AMW can support projects at various stages of development: from the joint evaluation of an early product concept through feasibility studies and formulation development to process development and the manufacturing of clinical supplies under GMP conditions. Ideally, AMW is involved at an early stage, as polymer selection, formulation design, extrusion process development and subsequent GMP transfer are closely interconnected. Early collaboration can help reduce development risks and facilitate future technology transfer.

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