Development and manufacture of products based on biodegradable starch microspheres (DSM) for medicine

Magle PharmaCept GmbH

Berlin, Germany · Malmö, SwedenNew on Amplifa

1999Founded as PharmaCept

2 sitesBerlin (DE) and Malmö (SE)

1–1000 µmDiameter range of the DSM microspheres

25+ yearsExperience in product development

About Magle PharmaCept

Magle PharmaCept GmbH is a medical device company founded in 1999 as PharmaCept and part of the Magle Group since 2021. The company develops and manufactures medical devices based on the patented DSM technology (Degradable Starch Microspheres): spherical, biodegradable and biocompatible microparticles made from potato starch with diameters of 1 to 1000 micrometers, which are degraded into glucose in the body. The microspheres are combined in gel, suspension, powder and solid formulations with various active ingredients and used in three clinical areas: surgery (SmartPAN for detecting pancreatic leaks), drug delivery in oncology (EmboCept S DSM 50 µm for temporary vascular occlusion) and advanced wound care. The entire value chain from discovery through research and manufacturing to regulatory affairs and commercialization is united in-house. The manufacturing and development site is located in Malmö (Sweden), while the international hub with close collaboration with academia and clinics is in Berlin.

Site: Berlin
Processes: DSM manufacturing (Degradable Starch Microspheres), Pharmaceutical formulation (gel, suspension, powder, solid form), Embolization and drug delivery (oncology), Surgical leak indication (SmartPAN), Advanced wound care (wound treatment), Research and Development, Manufacturing, Regulatory and Medical Affairs
Materials: Potato starch (biodegradable starch microspheres), Starch microspheres (1–1000 µm diameter), Degradable Starch Microspheres, DSM GelSpheres, DSM SuspensionSpheres, DSM PowderSpheres, DSM SolidSpheres
Certificates: Medical device approval (registered and approved)
Founded: 1999
Industries: Oncology (embolization, drug delivery), Surgery, Wound care, Medical devices

01
Discovery
02
Research and Development
03
Manufacturing (DSM formulation)
04
Regulatory and Medical Affairs
05
Commercialization

DSM Technology and Formulations

DSM

Degradable Starch Microspheres

Spherical, fully biodegradable and biocompatible microparticles made from potato starch (1–1000 µm) that are degraded into glucose in the body.

Gel

DSM GelSpheres

Gel formulations as a surgical adjuvant, postoperative active ingredient formulation, or topical gel in/on wounds.

Susp

DSM SuspensionSpheres

Stable suspension formulations, also combined with highly potent active ingredients such as cytostatics, administerable via microcatheter.

Pulver

DSM PowderSpheres

Powder formulations e.g. as a surgical hemostat or for inhalative and nasal active ingredient application.

Fest

DSM SolidSpheres

Solid formulations as dissolvable films, sponges and freeze-dried solids with active ingredient.

Sites

Malmö

Manufacturing and development site

Materials: Potato starch (DSM microspheres)

Berlin

International hub with close cooperation with academia and clinics

Products

**EmboCept® S DSM 50 µm**Starch microspheres · Oncology (embolization/drug delivery)

**SmartPAN®**DSM formulation · Surgery (leak indicator)

**Advanced Wound Care products**DSM formulation · Wound care

Inside the production

Industries

Oncology (embolization, drug delivery)SurgeryWound careMedical devices

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
DSM manufacturing (Degradable Starch Microspheres)Plastics	–	–	–	–	Potato starch
Pharmaceutical formulation (gel, suspension, powder, solid form)Plastics	–	–	–	–	Starch microspheres (1–1000 µm), active pharmaceutical ingredients, cytostatics
Embolization and drug delivery (oncology)Other	–	–	–	–	DSM starch microspheres
Surgical leak indication (SmartPAN)Other	–	–	–	–	DSM starch microspheres
Advanced wound care (wound treatment)Other	–	–	–	–	DSM starch microspheres

Additional services

Research and DevelopmentManufacturingRegulatory and Medical AffairsCommercialization

Reference customers

Sirtex Medical (distribution partner for EmboCept S DSM 50 µm)

Quality and Clinical Evidence

Magle PharmaCept places great value on clinical evidence: DSM products are registered and approved as medical devices in several therapeutic areas, and their application is supported by a large number of preclinical and clinical publications.

Evidence	Malmö
Medical device approval (registered and approved)

Company History

1999
Founded as PharmaCept
2021
Joined the Magle Group, renamed Magle PharmaCept