BioConnection services
Commercial Fill and Finish Services
BioConnection offers commercial fill and finish for your products. Our capabilities include liquid fill or lyophilization intended for vials, prefilled syringes or blowfill seals. Our large scale state-of-the-art fill and finish line enables you to scale up to commercial production in time for the market.
Clinical Fill and Finish Services
BioConnection offers clinical fill and finish for your products. Our capabilities include liquid fill or lyophilization intended for vials, prefilled syringes or blowfill seals. Fill and finish is the core of our company!
Drug Product Development Service
When you’re developing a finished dosage form, your project costs are most likely in a sound competition with your available funds. This is why choosing a CDMO is an important and long term decision. BioConnection can help you out with an oversight of the technology transfer and per-unit manufacturing cost. Let us also assist you with determining the often hidden costs: depending upon the mutual locations, you may incur costs for transportation, customs, duties, taxes and QP reviews. And worse, flaws in your (process) development could lead to mistakes, and even manufacturing problems. A functional relationship with your CDMO may prevent you to prevent costly do-overs. We try to help out by a dedicated Program Manager for each customer, providing a minimum ongoing oversight from your own. This way, you and your staff will remain available for other important activities.
Freeze Drying Services
Freeze drying brings stability and is therefore becoming increasingly popular. At BioConnection, we have many years of experience in the freeze-drying of sterile medicines. We offer freeze drying services for small or larger scale badges.
Finished Product
When your product leaves our facility, it needs a few additional steps in order to be ready for the clinic. These steps can also be provided by BioConnection. Depending on your needs and requirements, we can setup the further chain into the clinic. It’s a total package!
Large Scale Filling Capacities at BioConnection
Capacity: Liquids: up to 500L + / batch. Freeze dried: up to 200L/ batch. Up to 40 million vials/ year (2 RDIN, liquid). Up to 4 million vials/ year (2 RDIN, freeze dried). Speed (default): 11.520 vials/ hr (2 RDIN). Vial sizes: 2 RDIN up to 50 RDIN vials.
GMP Manufacturing Services
BioConnection offers access to state-of-the-art GMP manufacturing facilities and a broad range of support services. BioConnection operates from its proprietary FDA and EMA approved facility in Oss, the Netherlands. From this facility, we can provide you with clinical scale manufacturing in a wide variety of formats and techniques, including freeze-drying. Besides our expertise in development and manufacturing of clinical trial medication, we are your partner in proven track-record for global commercial manufacturing for small indications and orphan drugs. This is a unique proposition where you can rely on our experienced team and AAA-class facility.
Personalized Medicine
As per 2019, BioConnection offers new cleanrooms for Advanced Therapy Medicinal Products (ATMP) manufacturing, including Personalized Medicines and cell-based therapies (BSL2 classification). These areas can also be rented for (short) terms to, for example, your complex production process.
Multi-Purpose Suites
BioConnection has multi-purpose suites (GMP grade D) which can be used to perform GMP activities upon your specification. We can either perform these steps for you, or you can rent these areas for (short) terms for example for Medical Device projects requiring a GMP process step.
Handfill Services
Since 2019 BioConnection also offers access to a manual filling machine for small scale batches in standard vial formats, bottles, eyedrops, nasal sprays, etcetera. The actual fill is performed in a grade A cabinet, situated in a Grade B environment. All product contact components are disposable or dedicated, allowing us to work with a wide range of different products. Manufacturing on this line can also be completed with and a broad range of BioConnection support services.