Finding the right biopharmaceutical manufacturer for your product can be quite a challenge. You need a company that has decades of experience, yet still values small batch productions just as much as large volume formulas.
At Exelead, we work hard to give you the best of both worlds. Because we handle all of the manufacturing stages in house, it’s easier for us to maintain control of your product. By monitoring every step of production, we’re even able to customize our process to meet your exact specifications for manufacturing, packaging, and distribution.
Stages of Commercial Manufacturing
Having a completely in-house manufacturing process isn’t typical in the pharmaceutical industry, but it offers a lot of benefits. Choosing a single contractor can often help minimize downtime and eliminate errors. But more importantly, it can increase quality control across every stage of production.
1. Liposomal Formulations
There are plenty of contract manufacturers out there, but without a nimble production process and GMP systems, they might not be right for you and your product. Exelead has more than 20 years of experience in commercial liposomal manufacturing. Since this is our core competency, we work well with both large and small-scale pharma companies and small-batch clients.
Commercial manufacturers who are well versed in PEGylation services will be able to scale their production to suit your needs. At Exelead, we’re able to create single batches ranging from 1 liter, all the way to 1,000 liters. We can also work with first, second, and third generation PEG derivatives.
3. Aseptic Filling
Sterile environments, accurate fill weights, and compliance with EU/US regulations are of the utmost importance in pharmaceutical manufacturing and require special equipment. Exelead has a uni-directional airflow (UDAF) system and a Restricted Access Barrier System (RABS) to help keep your products safe.
4. Packaging and Inspection
Consistent temperature conditions and checking vial weights helps ensure that every unit has the correct dosage. Exelead facilities are equipped with automated inspections and have specific packaging protocols for printing cartons and labels. Depending on your product, you might also need tamper evident sealing.
And as the industry moves toward serialization, we’ve already incorporated the serialization process into our facilities, putting Exelead ahead of the industry standard.
5. Quality Control
Pharmaceutical manufacturers should make quality control a priority at every stage. Exelead takes this a step further by offering a vast array of quality control testing solutions. Our labs can run your chemical compound through a variety of analytical equipment, including: Agilent Gas Chromatography (GC), Ultra High Performance Liquid Chromatography (UPLC), Metrohm Polarography Analyzer, and more. With an emphasis on quality control at each phase of the manufacturing process, you can be assured that your product meets all specification requirements.
6. Supply Chain
Does your commercial contract manufacturer have a global presence? Safe shipping practices and logistics expertise don’t happen overnight. At Exelead, we’re proud to partner with brands who ship products near and far. Our cold chain process and distribution service providers help get your pharmaceutical product where it’s needed most.
Commercial Contracts with Exelead
Keeping pharmaceutical manufacturing under one roof helps streamline our process and protect the integrity of our clients’ products at every stage. From formulation and aseptic fills to cold chain management and distribution, you need a contract manufacturer you can trust. Exelead aims to be just that.
For more information on our developmental and commercial contract services, please contact us directly to request a proposal. Our team is ready to assist you in any way we can!
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