The Definition of a Biologic Product

The Definition of a Biologic Product

What is a biologic? According to the US Food and Drug Administration the FDA defines a biologic as ‘any product that is derived from natural sources that is produced using biotechnology methods and other cutting-edge technologies’. Biologic products can be composed of proteins, sugars, nucleic acids, or combinations of these to produce drugs as vaccines, blood and blood derived product, allergenics, somatic cells, gene therapy, monoclonal antibodies, antibody drug conjugates, tissues, and recombinant therapeutic proteins to name a few. Read more ›

Ask A Bioprocess Consultant: What Are Recombinant Proteins?

Recombinant proteins are a type of modified protein whose amino acid sequence is encoded by recombinant DNA which has been cloned into an expression vector and expressed through host such as bacteria, yeast or mammalian cells. Read more ›

biologics manufacturing

Bioprocess Scale-Up Consideration

Yes, it is unavoidable that your manufacturing process will undergo a scale-up at least once in the life cycle of your product. Typically, the first significant bioprocess scale-up goes hand-in-hand with the technology transfer of the process into GMP biologics manufacturing. Scale-Up can be particularly challenging for biologics as there are many variables at play which differ between microbial and mammalian expression systems. At BPAI, we have learned that the challenges are also very different for upstream compared to downstream processing. Read more ›

Bioprocess Consultants

The Ever-Important Cell Bank in Biologics Manufacturing

No one in the biologics industry can deny the critical importance of a well characterized, biologic -producing cell line – it is the cornerstone of not only the technical program in that it produces the biologic, but also critical intellectual property for the company’s future. So, what considerations should be taken into account when thinking about laying down the ‘ever-important’ cell bank? Let’s explore! Read more ›

Bioprocessing Technology Transfer and Scale-up

Over the last few years, the bioprocessing industry has had a high throughput rate for new product candidates in its attempt to find the next pharmaceutical blockbusters. This had led to an acceleration in pharmaceutical outsourcing for process and analytical activities. Pharmaceutical outsourcing starts with a technology transfer, which is typically one of many during the life cycle of any biopharmaceutical product. Read more ›

BPAI Pharma Outsourcing

Pharmaceutical Outsourcing

Running a Tight Request for Proposal Process; Part 3

Previously, I discussed data normalization of the proposal information, short listing, and the process of qualifying a shortlisted service provider.  In this final blog on pharmaceutical outsourcing, I am going to focus on the quality audit, the contract review process, and project kick-off. Read more ›

Pharmaceutical Outsourcing

Running a Tight Request for Proposal Process; Part 2

In my last blog, I began discussing the front-end of the Request for Proposal (RFP) process that is typical in pharmaceutical outsourcing: research, confidentiality, publishing the RFP, and establishing clear deadlines. In Part 2 of this blog, I am going to discuss data normalization of the proposal information, shortlisting, and the process of qualifying a short-listed service provider.
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pharmaceutical outsourcing

Pharmaceutical Outsourcing

Running a Tight Request for Proposal Process; Part 1

With the continued trend of increased outsourcing in the biopharma industry, a significant level of importance is being placed on the Request for Proposal (RFP) process. This makes sense – without a systematic approach to developing the RFP, soliciting bids from service providers, and then normalizing the bid information into a comprehensive package, it is possible to get muddled during contract award. Over the years, Bio-Processing Alliance has run more than 40 RFP processes, amounting to more than $40 million dollars in awarded contracts through our pharmaceutical outsourcing service. Read more ›

4 Things You Need To Know About Bio Processing Alliance

In the last seven years, Bio Processing Alliance, Inc. (BPAI) has established itself as a leader in the biologics consulting business.  Since the company’s inception, our commitment has been to enhance our client’s company value by awarding and effectively delivering,  biopharma development and manufacturing programs all over the world in support of clinical and commercial phase products. If you are just learning about our company, here are four things we want you to know about working with Bio-Processing Alliance. Read more ›