Locations

Bielefeld, Germany

Modified Release Pellet Manufacturing
Locations
Bielefeld, Germany
Modified Release Pellet Manufacturing

Bielefeld: Modified Release Pellet Manufacturing Centre of Excellence

NextPharma’s Bielefeld site, operating as PHARBIL Pharma GmbH, is the group’s centre of excellence for modified release pellet manufacturing, with particular depth in controlled release, gastro-resistance and taste masking technologies. With our quality control (QC) laboratory, our Bielefeld site combines development depth with commercial-scale throughput.

If you are evaluating a European CDMO for modified release or pellet-based dosage forms, discover NextPharma Bielefeld’s core capabilities, regulatory status, facility details, and how to start a conversation with the team.

The site

Primary capabilities

The Bielefeld site has been part of the NextPharma Group since 2000 and is purpose-built for the development and commercial manufacture and packaging of pellet-based dosage forms.

Our annual capacities include approximately 6,000 QC batches with around 300 validated methods. Our core technology platform covers pellet production by extrusion and spheronisation, combined with film coating and layering of pellets in both aqueous and organic processes, in the following core dosage forms:

 

Core dosage forms

Tableted pellets

Standart immediate release

Flavour and development on site

Our analytical services are available to our customers as an integrated or standalone service and include UHPLC, HPLC (DAD, FL, RI), GC (liquid, headspace, trap unit, FID), and dissolution testing across USP methods 1 to 3 (online and offline). A dedicated team covers formulation development, analytical development, clinical batches, scale-up and tech transfer, supporting programmes from early formulation through to commercial manufacture.

SERVICES

Additional capabilities

NextPharma Bielefeld offers a unique combination of specialised pharmaceutical capabilities, making the site a trusted partner for a wide range of additional capabilities:

01

Controlled release: Aqueous and organic film coating for controlled and modified release profiles (available solvents: ethanol, isopropanol and acetone)

02

Gastro-resistance: Enteric coating of pellets for delayed release

03

Taste masking: Coating of pellets and granules for palatability

04

Encapsulation: Pellets, granules, tablets-in-capsule, including double filling

05

Stick pack packaging: Stick pack lines with secondary packaging

06

Blister packaging: With secondary packaging

07

Analytical services: Method development, validation and transfer

08

Stability studies: Dedicated storage at a unique range of temperature and humidity conditions

For modified release manufacturing capabilities, see our modified release services. For analytical and microbiological services across the network, explore our analytical and microbiological services.

Regulatory status

Quality and compliance

Production at NextPharma Bielefeld operates under EU GMP requirements. Analytical services are FDA approved. The site holds ISO 50001 energy management certification and has passed SEDEX and PSCI audits.

Site & infrastructure

Facility

The Bielefeld site covers 14,800 m² of land with 3,400 m² of GMP manufacturing area, 1,000 m² of QC laboratory, 300 m² of dedicated stability storage, 1,700 m² of administration space, and warehousing supporting 2,100 pallet places across 3,200 m². A new extrusion-spheronisation line will be installed in 2026.

We have capacity to expand production and packaging by adding new lines, with significant warehouse space convertible into production area. We are open to installing clients’ equipment in our facilities or building dedicated production areas where a project requires it. For an overview of all our sites, visit the NextPharma locations hub.

More on this site

See Bielefeld, Germany for yourself

Length
Filmed

Analytical Services

GMP testing, method development and stability studies – backed by expertise in development and manufacturing.

Format

PDF · 8.6 MB

Pages

4

Language

English

Standards

EU GMP, FDA, ANVISA

Looking for official announcements?

Regulatory and corporate press releases live in our press area.

Instagram
Latest from Instagram
Get in touch
Talk to the NextPharma Bielefeld Team
To discuss modified release manufacturing, pellet-based formulation projects, or analytical services at NextPharma Bielefeld, contact us directly:

Address

PHARBIL Pharma GmbH, part of NextPharma Reichenberger Str. 43, D-33605 Bielefeld, Germany

Telephone

+49-521-20 83-0

Email

info@nextpharma.com

Get in touch with NextPharma

Whether it's development, manufacturing or supply. Tell us about your project and our experts will get back to you.