Biovian has answered to the growing need of full one-stop-shop services in cGMP contract manufacturing of injectables and sterile products with a new aseptic filling line, which has been successfully operational for several customer projects since the beginning of Q2/2009.
With this extended capacity, Biovian now has two stand-alone automated filling lines. One of the filling lines is designed for aseptic filling of small batches of hazardous (e.g. cytotoxic) materials in vials, while the other has higher capacity and typically accommodates aseptic filling of recombinant proteins or antibody products in vials.
Aseptic filling of a small number of vials with low losses of the expensive active pharmaceutical ingredient is a challenge that only a few can meet. One of the few that can is Finnish contract manufacturer Biovian.
“With our cGMP certification and aseptic filling project experience spanning over ten years as backbone, we can offer the one-stop-shop concept to our customers who need flexible aseptic filling solutions, e.g. filling of small batches comprising of only a couple of hundred vials,” says Dr Knut Ringbom, director of projects and marketing at Biovian. “We have two validated automated filling lines that both comply with EMEA and USP standards.”
Biovian’s inspected and cGMP certified 1,600m² cGMP facilities contain EU grade A, B, C and D class clean rooms and warehouse under full quality control, as well as extensively equipped development laboratories.
The flexible approach with a combination of automated processes, disposable techniques and highly skilled personnel allows Biovian to handle cytotoxic and other hazardous compounds, as well as recombinant proteins, with a minimum loss in the process.
“Of course if the batches are as small as a hundred vials or less, simply the amount of material needed for quality control will become relatively high,” says Knut Ringbom. “We are not daunted by having to break new ground while at the same time fulfilling the regulatory requirements. Our highly competent quality staff knows where our limitation lies when discussing with our clients.”
“Naturally we also offer formulation, dilution, full QC testing, labelling, secondary packaging and warehousing of both active drug and placebo, and our Qualified Person can release vials from the same batch to clinical studies at several occasions, all in accordance to the needs of our client,” adds Knut Ringbom.
Summary
Biovian’s aseptic filling and finishing cGMP services include aseptic filling in vials using the company’s two stand-alone automated fill lines. Typical vial sizes are 2ml to 15ml. If required, lyophilization of the drug product is also offered. The sterile manufacture of injectables is offered for investigatioinal and commercial use. Biovian’s high-value package of aseptic filling services also includes dilution, formaulation, full QC testing, individual labelling, colour coding, secondary packaging and warehousing, as well as QP release and delivery to a designated trial site.