Ensuring the identity, purity, safety and quality of your biopharmaceutical at every stage.

RSSL is your trusted partner for:

yy Analytical testing yy Consultancyyy Training

Outstanding quality, scientific excellence and customer satisfaction

Biopharma Boom Brings Benefits to CROs

Visit RSSL on stand 32624th–25th April, Ricoh Arena, Coventry

Tel: +44 (0)118 918 4076 Email: enquiries@rssl.com Web: www.rssl.com

see pages 36-37

DRUG DEVELOPMENT Improved outcomes during clinical trials fordrug candidates using tailor-made molecules

LABELLINGAddressing future regulations with quality coding for pharmaceutical packaging

REGULATION GDPR versus privacy: what you need to know to become compliant

Volume 89 Number 4 April 2018

THE LEADING JOURNAL FOR THE PHARMACEUTICAL INDUSTRY

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disease targets continues to improve, the focus hasmoved from chemical hits on disease molecules tobiological hits. Capacity has increased steadily,and the processes for making biopharmaceuticaldrugs have now become part of the everydayindustry toolbox.“This is probably the time of greatest change in

the industry,” says Phil Kuhlman, TechnicalSpecialist, Biopharmaceutical Analysis, at RSSL.

RSSL’s Phil Kuhlman, Technical Specialist,Biopharmaceutical Analysis, and DaleHreczuk-Hirst, Biopharmaceutical BusinessDevelopment Manager, look at the advantages ofusing an outsourcing partner and, mostimportantly, how to find the right one. During thepast 20 years, the biopharma market hasexpanded rapidly and there is no sign of thisgrowth slowing down. As the understanding of

36 manufacturing chemist April 2018

The analytical outsourcing sector is well placed to benefit fromthe continuing rise in biopharmaceutical manufacturing

Biopharma boombrings benefits to CROs

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“There is a move from small molecule to largermolecular drugs as the biologics toolkit createsnew approaches to treat diseases that smallmolecule drugs could not address a decade ago. Weare now able to tackle diseases that wereuntreatable 10 years ago.”Furthermore, the regulatory environment for

getting drugs to market is changing: productionruns are much smaller and there is an increasingfocus on orphan drugs aimed at far lower patientpopulations. Typically, these drugs have a shortenedregulatory path so they can get to market quicker,and the companies that are developing them andtaking them through Phase III trials and on tocommercialisation are often much smaller than waspreviously the case. Smaller companies may nothave much experience in the analytical side ofresearch and is likely to turn to an outsourcingpartner to support its activities.“In light of these trends, an outsourcing partner

needs to be more technically adept and moreflexible than ever before,” says RSSL’s DaleHreczuk-Hirst, Biopharmaceutical BusinessDevelopment Manager. Targeting rarer and rarerdiseases with smaller numbers of patients willinvolve greater flexibility … and will require anoutsourcing partner that is not only able to keepup but has the ability to drive the product tomarket more quickly.

Burgeoning biosimilars“Another major area of opportunity for theoutsourcing sector is biosimilars. The growth inthe number of biosimilars coming onto the marketwill drive down prices” Hirst suggests, andmanufacturers will turn to outsourcing partnersas a more cost-effective alternative to having theirown analytical team or making a significantcapital investment in analytical instrumentation.Furthermore, biosimilars require a large number

of tests. Seven years ago, it was necessary tocompare three lots of the biosimilar against threelots of the innovator molecule in a full barrage ofapproximately 20 tests. But, for the last 3 years,everything that comes onto the market has to betested at the beginning, middle and end of its shelf-life. “So, we’ve moved from a three-lot comparisonto a comparison of up to 30 or more lots, each ofwhich must be tested three times,” Hirst explains.“With biosimilars, it all revolves around knowingeverything about the innovator molecule.”

Quality and experienceNot only can using an outsourcing partner be cost-effective, it can also bring a level of expertise thatmay not be present within the biosimilarmanufacturing company. Executing a comparativestudy for the first time is a very differentproposition from using a partner who has done itmany times and built up considerable experience,Kuhlman points out.Knowledge and technical expertise are two of

the most important considerations whenbiopharma companies are looking for a suitableanalytical outsourcing partner, along withflexibility and range of equipment. For Hirst, thekey is technical expertise: in the first place, to save

April 2018 manufacturing chemist 37

time so that costly errors don’t occur; andsecondly, to advise the client and avoid expensivetime delays.The quality side of outsourcing is, of course, the

bedrock of any partnership, but these days it’s agiven: provided the partner is FDA inspected andMHRA approved, it is guaranteed to operate at ahigh quality standard. RSSL is not only FDA andMHRA approved, it’s also one of the best equippedservice providers across a wide range of analyticaltechnologies. The company covers 95% of theneeds of most clients, although it stillsubcontracts some activities, such as tissueculture and bioassays to specialist partners.Of course, not all players in the biopharma sector

are looking for the same things from their analyticaloutsourcing partner. Small, spinout companies, forexample, who have taken their idea as far asPhase II, may need further support in the form ofexpertise in getting to market and navigating theregulatory pathway. Alternatively, medium-sizedcompanies and contract manufacturers may justneed additional capacity to cope with peaks inworkload, whereas larger biopharma companiesmay be looking for extra capacity or to scale-downtheir own operations to reduce costs.But there’s more to selecting an outsourcing

partner than merely finding a laboratory that canoffer the required testing services. The focusshould not just be on the immediate need for aservice but should take into account the broaderpicture and how that relationship might grow inthe future. “The selection of your outsourcingpartner is critical,” says Kuhlman. “If you find apartner that can do the tests, that’s great; but, ifanything goes wrong and that partner can’tcomplete the investigation or can’t discover whyproduct is out of specification, then it ultimatelyends up being more costly in the long run.Reliability and the building of trust in therelationship is absolutely crucial, and that’s whatwe offer.”Customer service is seen as something of a

cliché these days, but flexibility, goodcommunication, consistently meeting deadlinesand putting the client first whenever possible areall prerequisites for a long-term relationship. It’snot all about the tests, Hirst agrees, it’s aboutwhen clients are in trouble and need help. Andthat help is available 24/7, 365 days a year.RSSL offers a wide range of expertise,

concerning not only the large molecule but alsoraw materials, contamination issues and packaginganalysis throughout the product lifecycle. For anygiven project, a multidisciplinary team will be puttogether, with consultants on hand to fill in anyareas not covered in-house. The reliability of apotential outsourcing partner is another factor totake into consideration. RSSL is financially stable,has been in the industry for many years andintends to be around for many more.“It’s a matter of trust,” Kuhlman stresses. “If

you are trying to release your multimillion poundproduct onto the market, you really don’t want aCRO to hold that up. You need to have the trustthat they are going to get the job done. That is thekey to successful partnerships.”

FOR MOREINFORMATIONPhil KuhlmanTechnical Specialist,Biopharmaceutical AnalysisDale Hreczuk-HirstBiopharmaceutical BusinessDevelopment ManagerRSSLT: +44 118 918 4076E: enquiries@rssl.comW: www.rssl.com

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