Your New Product Edge: Product & Process Development at Ben Venue

Q. What does Ben Venue need to get started on my project?

A. We must first determine what has already been done and what remains to be done. We do this through our Product Questionnaire.

Q. What kind of questions are asked?

A. First, we will ask if you prefer a lyophilized or a liquid formulation. Then, we ask if you have a formulation and analytical methods. We will also find out if you have selected packaging components and the status of any preformulation studies and storage criteria.

Q. What's the next step?

A. We will invite your technical staff to come to Ben Venue for a discussion to review the information you provided on the questionnaire and determine what is needed to fill in the gaps.

Q. What if we haven't done anything and can't answer any of the questions?

A. We will jointly develop a program to get the information required. Essentially, you will be entering the highway at entrance ramp 1. At this point, Ben Venue will:

·Establish formulation guidelines for sterile liquids, whether aseptically filled or terminally sterilized

· Establish formulation guidelines, precautions and controls that take advantage of our flexibility in manufacturing using lyophilization or vacuum-drying processes

· Develop, apply and validate analytical techniques for measuring concentrations of active ingredients and excipients

· Match drug, excipient and solvent systems with various filtration media to attain compatibility and efficiency

· Perform stability studies in temperature-controlled storage areas to establish product shelf life and expiration dating

Q. In your technical discussions, I've heard the term "PIP" often. What is this?

A. The PIP (Product Information Package) summarizes how to manufacture and test the product and is used as a framework for the preparation of manufacturing and QC documentation. It is the roadmap which guides Production and Quality Control.

Q. Tell me more about this "journey." I see that there are various entrance ramps to your highway. What are these for?

A. Although Ben Venue is the only place that can take your product from an active material ("test tube miracle") to commercial production, sometimes products enter our highway after work has been done elsewhere. However, if you are at the beginning of the journey (no development work has been done), you will travel fastest if you stay with us through completion.

Q. Why is that? I've heard that there are laboratories that can do the development work for us rather quickly.

A. There are some fine sources for development work in the U.S. Some are university-related; others independent. Many can even do pilot scale manufacturing after they have done your formulation and analytical work. But only Ben Venue can develop and then manufacture all of your clinical and commercial scale batches under cGMPs. (Remember, your Phase III batches are beyond pilot scale size.)

Q. What if we've already had some development work done before we come to Ben Venue?

A. We will compare what you've done versus what needs to be done in order to develop a program to get your product ready for commercial production. (We will produce a PIP to summarize your product's situation.)

Q. Will you recommend changes?

A. Yes. Where appropriate we will recommend changes. The lyophilization cycle may not be appropriate to our equipment. We may also know the cycle could be optimized.

Q. How much involvement will the customer have?

A. As much or as little as you wish, but as a minimum: approval of specifications for active drug substances and finished product, analytical methods, stability protocol, and production documents.

Q. What if we need assistance preparing regulatory documents?

A. Ben Venue has a staff of regulatory associates who can assist you in preparation of the CMC (Chemical Manufacturing and Control) section of a NDA, anda or 501K device submission. You are still responsible for your submission, but you will use the information generated by Ben Venue.

Q. Do you run stability studies?

A. Yes, we will do this for our customers for whom we have produced finished dosage forms and who are unable to do so for themselves.

Usually, Product Development performs a minimal stability study on formulations they develop. The results from this minimal study will determine if the formulation goes into production.

Q. Is there a limitation on batch size?

A. No, we'll do any size, even a single liter or less.

Q. What is Ben Venue's track record?

A. Ben Venue is the oldest and most experienced contract manufacturer of lyophilized products in the United States.

We have a history of excellence with numerous well-known, satisfied customer accounts and more than 300 individual pharmaceutical products.

As testimony to our proven capability, Ben Venue has held development and production contracts with the National Cancer Institute for over two decades. In addition to clinical dosages of antitumor agents, since 1985, we have been developing and manufacturing anti-AIDS products for the NCI.

Q. How can we be sure of confidentiality?

A. We never would have become the world's largest contract manufacturer of sterile products without trust. Over 500 products have been successfully developed and produced in complete confidence. Strict segregation of client products, supplies and records is our way of life.

Q. Can we be assured of long-term supply?

A. Ben Venue will enter into long-term supply agreements with customers to assure them a supply of consistently superior products. By knowing that they will be provided with a timely supply of product, customers can concentrate their efforts and capital on research rather than on production.